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Industry News - June 13, 2013
By: Kristen N. Reabe, PharmD
Industry News
UPCOMING POTENTIAL LAUNCHES
Aciphex: Potential launch 11/8/13.
Asacol: Potential launch 7/30/13.
Cymbalta: Potential launch 12/11/13.
Focalin XR: Potential launch in Q3 2013.
Lidoderm: Potential launch in Q3 2013.
Niaspan: Potential launch 9/20/13.
Retin-A Micro Gel: Potential in Q2 2013.
Soriatane: Potential multi-supplier launch in Q2 2013.
INDUSTRY UPDATES
Glenmark recalls three drugs
Glenmark voluntarily recalled several lots of Gabapentin, Pravastatin, and Topiramate from the U.S. market primarily due to an "odd smell". The drugs include 33,138 bottles of Gabapentin Tablets 600mg, 9,278 bottles of Gabapentin 800mg, 246,528 bottles of Pravastatin, and 9624 bottles of Topiramate tablets. Citing insignificant financial implications of these recalls, a company spokesperson said, "All recalls pertain to off-odour complaints from bottles supplied by one HDPE bottle supplier whose services are not being used by the company anymore." The company had recalled many lots of Montelukast Sodium Tablets, 10mg packaged in 30 and 90 count tablets per bottle in February 2013 from the U.S. market, due to similar reasons. (PRB Regulatory Affairs News 5/27/13)
Valeant confirms $8.7 billion deal to buy Bausch + Lomb
Valeant is buying Bausch + Lomb in a $8.7 billion cash deal that will boost the Canadian drug maker's presence in the eye-care sector. Valeant will hire some of Bausch + Lomb's senior executives to the U.S.-based global business, which is best known for its contact lenses and solutions. Bausch + Lomb's chief medical officer, Dr. Calvin Roberts, will join Valeant in a similar role as will Dan Wechsler, who will become a Valeant executive vice-president and group chairman of ophthalmology and eye health. Valeant said it expects additional members of the Bausch + Lomb management team will join later. About half the purchase price will be used to repay Bausch + Lomb's outstanding debt and $4.5 billion will go to an investor group led by Warburg Pincus, which bought the company in 2007. The acquisition will put Valeant in competition with established players like Novartis, Allergan, and Johnson & Johnson, which lead Bausch & Lomb in most product categories. (Canadian Press 5/27/13)
FDA raises concerns at Hospira facility
Hospira announced it received a warning letter from the FDA, raising concerns about contamination of drugs manufactured at its facility in India. The letter followed an October inspection of the facility in Tamil Nadu, where the FDA said it found significant violations of quality regulations for finished drugs. The FDA stated it found that surfaces in the facility were not always sanitized prior to use and that sterile drug products were not protected from contamination. Hospira entered into an agreement in August to buy a factory and research center from India-based Orchid in a bid to reduce costs. Hospira has been facing multiple regulatory issues at its manufacturing plants since 2010, and withdrew its 2013 profit and revenue outlook in February after the FDA banned the import of some of its products. (Reuters 5/30/13)
Industry News - May 24, 2013
By: Kristen N. Reabe
Industry News
UPCOMING POTENTIAL LAUNCHES
Aciphex: Potential launch 11/8/13.
Asacol: Potential launch 7/30/13.
Cymbalta: Potential launch 12/11/13.
FocalinXR: Potential launch in Q3 2013.
Lidoderm: Potential launch in Q3 2013.
Niaspan: Potential launch 9/20/13.
Retin-AMicro Gel: Potential in Q2 2013.
Soriatane: Potential multi-supplier launch in Q2 2013.
RECENT LAUNCHES
FDA approves generic Zomig and Zomig-ZMT
The FDA has approved generic versions of IPR Pharmaceuticals' Zomig and Zomig-ZMT. Mylan announced the approval of zolmitriptan 2.5mg and 5mg tablets and plans to launch the product immediately. Apotex's products are AB-rated Zomig and Zomig-ZMT and will be distributed by Impax Laboratories. According to IMS, sales were $153 million for the regular tablets, and $44million for the orally disintegrating tablets, for the 12 month period thatended in March. (DrugStoreNews 5/15/13, Apotex Press Release 5/15/13)
Sandoz launches generic Atacand
The FDA has approved Sandoz's candesartan cilexetil tablets, a genericversion of AstraZeneca's Atacand. Thedrug is used to treat some types of heart failure in adults with left ventricular systolic dysfunction, as well as high blood pressure in adults and children as young as 1. Atacand had sales of $120.3 million in 2012, accordingto IMS Health. (DrugStoreNews 5/22/13)
INDUSTRY UPDATES
Generic use reached 84% in 2012,according to new study
Declining overall use of healthcare services drove down U.S. drug spendingby 3.5% per capita last year, according to a new study by IMS Health. The study showed total spending on medications reached $325.8 billion last year, or $898 per capita, down by $33 per capita from 2011. Fewer patient visits to physician offices, fewer non-emergency admissions to hospitals and outpatient centers and a less severe flu season in early 2012 were all factors in the decline, according to the report, titled Declining Medicine Use and Costs: For Better or Worse? However, $28.9 billion of the reduction came from brand patent expirations, which IMS called the"largest-ever impact" as patients moved to cheaper generic drugs. Per capita medication use declined by 0.1%, partly due to milder cough, cold and flu seasons in the first months of 2012. Meanwhile, use of generics has increased to 84% of all prescriptions, while price increases and lower spending on recently launched drugs have driven spending down as well. Healthcare costs remain concentrated among patients with multiple chronic conditions, cancer and other complex conditions normally treated with specialty drugs; among those with commercial insurance, 5% of those younger than 65 incurred 51% of total healthcare costs, using more than $15,684 per person. (DrugStoreNews 5/9/1
U.S. specialty drug spending forecast to rise 67% by 2015
U.S. spending on specialty prescription drugs is projected to increase 67% by the end of 2015, according to new forecasts. U.S. prescription drug spending on eight of the top 10 specialty therapy classes will continue to increase overthe next three years, due to the robust pipeline of new biologicals and to physicians delaying treatment of patients until the new drugs are on the market, according to the study from Express Scripts. By the end of 2015, cancer, Multiple Sclerosis and Rheumatoid Arthritis will each command higher drug spending than any other therapy class in the U.S. except diabetes, the company forecasts. It also expects spending on hepatitis C treatments to quadruple over the next three years - the largest percentage increase by far among therapy classes. By the end of 2015, spending on hepatitis C drugs will exceed that of more common conditions, such as hypertension, as a result of the new interferon-free medications which are expected to gain FDA approval next year, as well as greater numbers of diagnoses resulting from new screening guidelines. (World News 5/22/13)
Ranbaxy to pay $500 million on felony charges
Ranbaxy Laboratories pleaded guilty to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the U.S. Department ofJustice. The settlement is the largest ever with a generic drug manufacturer over drug safety, according to the U.S. government. It includes $150 million in payments for a criminal fine and forfeiture and $350 million in payments for civil claims. Ranbaxy pleaded guilty to three felony counts related to the manufacture of drugs at two Indian locations that did not meet safety standards and to four counts of making material false statements. In the civil settlement, Ranbaxy has agreed to pay $350-million to resolve allegations that drugs from the two Indian plants did not meet specifications and that false claims were submitted to U.S. government health-care programs between April 1, 2003, and September 16, 2010.In 2008, the FDA banned the company from selling more than 30 drugs inthe U.S. after it found manufacturing deficiencies at facilities in India. In 2009, the FDA accused the company of falsifying data and test results in drug applications and halted reviews of drugs made at a plant in northern India. (The Globe & Mail, Associated Press5/13/13)
Drug shortages persist despite federal efforts to stop them
The number of ongoing prescription drug shortages has remained constant since July 2012, when a law designed to address the issue was enacted, according to new data from the University of Utah Drug Information Service(DIS). However, the data also show that the number of new shortages has dropped sharply. Although the FDA has received more notifications of production disruptions and shortages each month since the law was enacted, shortages of certain drugs have continued. Most recently, pediatricians have reported shortages of several essential electrolytes and other nutrients. The FDA and some observers state manufacturers' lack of quality is the cause of the shortages, noting that production problems at some sterile injectable drug manufacturing plants have forced their closures, resulting in shortages of such drugs. (The Daily Briefing 5/16/13)
Actavis to Buy Warner Chilcott for $5 Billion
Actavis agreed to acquire Warner Chilcott for approximately $5 billion excluding net debt in a deal to expand in women's health and urology. The combined company will have $11 billion in annual revenue as Actavis also adds gastroenterology and dermatology businesses, according to the statement. More than a year ago, Warner Chilcott, based in Dublin, disclosed that it was in discussions with potential bidders and conducting a strategic review. "The combination of Actavis and Warner Chilcott creates a strong specialty brand portfolio focused on therapeutic categories with strong growth potential and is supported by a deep pipeline of development programs," Actavis Chief Executive Officer Paul Bisaro said in the statement. (Bloomberg 5/20/13)
Industry News - May 9, 2013
By: Kristen N. Reabe, Pharm.D
Industry News
PRODUCT UPDATES
Ranbaxy sued by Acura over Oxecta
Acura sued Ranbaxy over its plan to market a generic version of Oxecta. Acura claimed Ranbaxy wrongly plans to market a copy of the short-acting oxycodone product before Acura's patent expires in 2025, according to papers filed in federal court. (Bloomberg 5/2/13)
Actavis can launch generic OxyContin in January 2014 under settlement with Purdue
Actavis is settling a patent-infringement suit with Purdue concerning OxyContin, Actavis announced, saying it expected to make more than $100 million in the deal between 2014 and 2015. Under the settlement, Actavis will be able to market a limited quantity of its version of oxycodone extended-release tablets, starting on January 1, 2014, pending FDA approval. If Actavis is unable to get approval from the FDA, it will be allowed to market an authorized generic version starting in October 2014. Actavis' generic, like Purdue's brand version, includes abuse-deterrent properties designed to make the drug less useful if it is crushed or dissolved. The announcement comes less than two weeks after the FDA announced that it would not approve any generic of the old version of OxyContin, which did not include abuse-deterrent features. Purdue withdrew that version of the drug in 2010. (DrugStoreNews 4/26/13)
Actavis to launch generic Intuniv in December 2014
Actavis can launch a generic version of Shire's Intuniv next year under an agreement between the two companies. The drug manufacturers announced they settled a patent-litigation suit concerning Intuniv (guanfacine hydrochloride), allowing Actavis to launch in December 2014 and also settling outstanding litigation against a regulatory filing by Actavis predecessor Watson for FDA approval of a generic version of the drug. The FDA approved Actavis' version of the drug in October 2012 and, as the first company to file a complete ANDA, Actavis is entitled to 180 days of market exclusivity in which to compete directly with the branded version after launching it. Under the terms of the deal, Shire will receive a 25% royalty on Actavis' gross profits from the drug.
Intuniv had sales of approximately $475 million during the 12-month period that ended in January, according to IMS Health. (DrugStoreNews 4/25/13)
Prasco to distribute authorized generic of Dibenzyline
Prasco has signed a deal with WellSpring Pharmaceutical to market an authorized generic version of phenoxybenzamine hydrochloride capsules, used to control episodes of hypertension and sweating associated with pheochromocytoma. The drug is an authorized generic version of WellSpring's Dibenzyline. An authorized generic is a branded drug marketed under its generic name at a discount, usually under a deal between the branded drug's manufacturer and a third-party company. (DrugStoreNews 5/1/13)
INDUSTRY UPDATES
U.S. drug spending down in 2012
Patent expirations on brand drugs such as Lipitor and Plavix has resulted in modestly less spending on medications in the United States for the first time in at least 55 years, according to a report released from the IMS Institute of Healthcare Informatics. Overall U.S. drug spending totaled $325.8 billion in 2012, down 1 percent from 2011, according to the report. Adjusting for population, per capita spending fell 3.5 percent to $898. The drop - the first since IMS began tracking drug prices in 1957 - marks the beginning of what is expected to be several years in which U.S. spending on prescription drugs will grow more slowly than overall healthcare costs, according to Michael Kleinrock, director of research development at IMS. The biggest factor behind the drop was the availability of lower-cost generic versions of drugs such as Pfizer's Lipitor. New generics contributed $28.9 billion to last year's reduction in drug spending. (The Globe & Mail 5/8/13)
Industry News - April 23, 2013
By: Kristen N. Reabe, Pharm.D
Industry News
RECENT LAUNCHES
Actavis relaunches generic Yaz
A federal court ruling has allowed Actavis to relaunch Vestura (drospirenone 3 mg and ethinyl estradiol 0.02 mg), a generic version of Bayer's Yaz. The relaunch follows a ruling by the U.S. Court of Appeals for the Federal Circuit that invalidated one of Bayer's patents on Yaz. Actavis originally launched its product in January last year, but a ruling by the U.S. District Court for the District of Nevada forced it to stop marketing the product two months later. Branded and generic versions of Yaz had sales of approximately $347 million during the 12-month period that ended in February 2013, according to Actavis. (DrugStoreNews 4/18/13)
PRODUCT UPDATES
FDA bars generic OxyContin
The FDA announced that they will not approve any generic versions of the original form of OxyContin, which was widely abused when crushed then sorted or injected. At the same time, the FDA approved new labeling for a reformulated OxyContin, which was introduced by Purdue in 2010. The label will indicate that the tablets' physical and chemical properties make them more difficult to crush, meaning abuse is less likely than the original version. (Reuters 4/16/13)
FDA grants tentative approval to two Sun generics
Sun announced tentative FDA approvals of sitagliptin and metformin hydrochloride extended-release tablets, generic versions of Merck's Januvia and Santarus' Glumetza, respectively. Tentative approval means that the drugs meet the FDA's requirements for approval, but the agency cannot give final approval until the brand-name drugs' patents have expired. Patents covering Januvia are scheduled to expire starting in April 2017, while those covering Glumetza are expected to expire starting in September 2016, according to FDA records.Sitagliptin tablets have annual sales of approximately $2.7 billion, while metformin hydrochloride extended-release tablets have sales of about $140 million, according to Sun. (DrugStoreNews 4/19/13)
Industry News - April 5, 2013
By: Kristen N. Reabe, PharmD
Industry News
UPCOMING POTENTIAL LAUNCHES
Oxycontin: Potential multi-supplier on 4/16/13. Generic may not launch due to formulation issues.
Soriatane: Potential launch in April by Teva and an authorized generic.
Zomig: Potential launch in mid-May be multiple suppliers.
RECENT LAUNCHES
Mylan launches generic Zovirax
Mylan announced the approval of acyclovir ointment 5%, a generic version of Valeant's Zovirax, used to manage initial genital herpes and in limited, non-life-threatening mucocutaneous herpes simplex virus infections in patients with compromised immune systems. Various versions of the drug had sales of approximately $230 million in 2012, according to IMS Health. Mylan stated it would start shipping the drug immediately. (DrugStoreNews 4/3/13)
PRODUCT UPDATES
Mylan can launch generic Fortamet in August
Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of Fortamet. Mylan stated that under the agreement, it can launch its metformin hydrochloride extended-release tablets in the 500mg and 1,000mg strengths on August 1. Metforminhydrochloride extended-release tablets in those two strengths had sales of approximately $125 million during the 12-month period that ended in September, according to IMS Health. (DrugStoreNews 3/14/13, PharmaLive 3/14/13)
Actavis can launch generic Crestor in2016
Undera deal with AstraZeneca to settle a patent-infringement lawsuit, Actavis willbe allowed to launch its generic version of Crestor (rosuvastatin calcium)tablets 67 days before July 8, 2016, when the drug's market exclusivity for usein children expires, at a fee of 39% of net sales to AstraZeneca. Actavis can also launch rosuvastatin zincalternate salt starting on May 2, 2016, but the company stated it had made no decision regarding a potential launch. "This agreement ensures that consumers will benefit from an earlier launch of arosuvastatin calcium product and eliminates ongoing litigation and uncertainty of marketplace acceptance of a non-generically substitutable product if Actavishad proceeded to launch the alternative product," Actavis president and CEO Paul Bisaro said. Crestor had sales of $4.4 billion in 2011, according to IMS Health. (DrugStoreNews3/25/13)
March 27, 2013
PPSC Attends NCAP Day in the Legislature
PPSC attended the North Carolina Association of Pharmacists' (NCAP) "Day in the Legislature" in Raleigh, NC in order to promote pharmacy and educate lawmakers.
April 3, 2013
2014 CMS Part D Call Letter (Final)
CMS has released the final 2014 Part D Call letter which describes the parameters by which CMS expects plans to operate for 2014.
Attachment: NCPA_2014 CMS_Final_Call_Letter.pdf
Industry News - March 20, 2013
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Oxycontin: Potential multi-supplier on 4/16/13. Generic may not launch due to formulation issues.
Soriatane: Potential launch in April by Teva and an authorized generic.
Zomig: Potential launch in mid-May be multiple suppliers.
RECENT LAUNCHES
Dr. Reddy's launches generic Zometa
Dr.Reddy's announced the launch of injectable zoledronic acid 5mg/5mL, a generic version of Novartis' Zometa. The drug is used to treat cancers that have spread to the bones and multiple myeloma. (DrugStoreNews 3/5/13)
FDA approves Par's generic Luvox CR
Par announced the approval and shipment of fluvoxamine maleate extended-release capsules, a generic version of Jazz Pharmaceuticals' Luvox CR. Par stated it was the first company to file a complete regulatory approval application for a generic version of the drug, thus entitling it to 180 days of market exclusivity in which to compete directly with the brand. Luvox CR has annual sales of approximately $51 million, according to IMS Health. (DrugStoreNews 3/15/13)
Perrigo to launch generic Mucinex Extended Release Tablets Perrigo announced that it has begun shipments of Guaifenesin 600mg Extended-Release tablets, the generic equivalent of Mucinex 600mg Extended Release tablets. The product will be packaged and marketed under store and proprietary brands. (PharmaLive3/19/13)
PRODUCT UPDATES
Mylan can launch generic Fortamet in August
Mylan has settled a patent-infringement lawsuit filed by Shionogi over its generic version of Fortamet. Mylan stated that under the agreement, it can launch its metformin hydrochloride extended-release tablets in the 500mg and1,000mg strengths on August 1. Metforminhydrochloride extended-release tablets in those two strengths had sales of approximately $125 million during the 12-month period that ended in September, according to IMS Health. (DrugStoreNews 3/14/13, PharmaLive 3/14/13)
Actavis seeks approval for generic Exelon
Actavisis challenging Novartis' patent on its Exelon patch used to treat Alzheimer's disease. Actavis filed an amendment with the FDA to its regulatory application for rivastigmine transdermal system to include the 13.3mg/24 hour. Novartis filed suit against Actavis seeking to prevent commercialization of the generic version of Exelon. In November 2011, the company, then known as Watson, filed an application with the FDA for a generic version of Exelon in the 4.6mg/24-hours and 9.5mg/24-hours strengths. Novartis sued to prevent commercialization of those strengths separately. Actavis stated it was likely the first company to file applications for generic versions of Exelon, which would entitle it to 180 days of market exclusivity in which to compete directly against the brand. Exelon had sales of approximately $521 million during the12-month period that ended in January, according to IMS Health. (DrugStoreNews 3/12/13)
INDUSTRY UPDATES
Walgreen signs AmerisourceBergen deal
Walgreen and Alliance Boots GmbH agreed to have AmerisourceBergen Corp. handle their pharmaceutical distribution and gained the option to acquire aminority stake in the company. The agreement with AmerisourceBergen to distribute branded and generic pharmaceuticals will start in September and last 10 years, the companies said in a statement. Cardinal Health, whose contract with Walgreen to distribute drugs won't be renewed, dropped the most since June 2009. The partnership will reduce costs, provide daily delivery of drugs to stores and boost sales of cancer and other specialty medicines for Walgreen, which last year bought a 45 percent stake in Alliance Boots for $6.7 billion tocreate a global chain of pharmacies. Cardinal Health said its contract with Walgreen had generated 21 percent of revenue in fiscal 2012. (Bloomberg 3/20/13)
Industry News - March 7, 2013
By: Kristen N. Reabe
Industry News
UPCOMING POTENTIAL LAUNCHES
Fosrenol: Potential launch in first quarter by Lupin, Mylan, Teva.
Oxycontin: Potential multi-supplier on 4/16/13. Generic may not launch due to formulation issues.
Soriatane: Potential multi-supplier launch in Q2 2013.
Taclonex Ointment: Potential co-exclusive launch expected in first quarter with Sandoz and Perrigo.
Valcyte: Launch was originally expected 3/1/13, but has been delayed until September due to pediatric extension.
RECENT LAUNCHES
Actavis' generic Suboxone receives FDA approval
Actavis announced that it has received FDA approval on its Abbreviated New Drug Application (ANDA) for Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, the generic equivalent to Reckitt Benckiser's Suboxone.
Actavis intends to begin shipping the product immediately. Suboxone is indicated for maintenance treatment of opioid dependence. (PharmaLive 3/1/13)
Amneal receives FDA approval for generic Suboxone
Amneal has received FDA approval for its generic version of Reckitt Benckiser's Suboxone (buprenorphine HCl and naloxone HCl Dihydrate) sublingual tablets for maintenance treatment of opioid drug dependence. Annual U.S. sales of Suboxone in all dosage forms are approximately $1.5 billion, according to December 2012 IMS Health data. (PharmaLive 2/25/13)
Mylan launches generic Antara
Mylan has begun shipping fenofibrate capsules, a generic version of Lupin's Antara. Various versions of the drug had sales of approximately $60 million during the 12-month period that ended in September 2012, according to IMS Health. (DrugStoreNews 3/1/13)
PRODUCT UPDATES
Shire pays $48 million to end Adderall lawsuit
Shire has settled all litigation with Impax concerning a dispute over a generic version of Adderall XR (mixed amphetamine salts). Shire has been supplying Impax with an authorized generic of Adderall XR since October 2009 but a year later the former filed suit claiming a breach of supply obligations. Shire responded with a counterclaim relating to Impax' ordering practices under the agreement. Now the two suits have been dismissed and the companies have entered into an amended agreement until the end of the supply term, September 30, 2014. As part of the settlement, Shire will make a one-time cash payment to Impax of $48.0 million. Teva has also been selling an authorized generic version and the FDA approved Actavis' generic last June. Impax will continue to pursue FDA approval for its own generic, which was filed with the agency in September 2003. (Pharmatimes 2/11/13)
Teva gets FDA approval for generic Adderall XR
Teva announced that it received marketing approval for its generic version of Shire's Adderall XR. Teva sells an authorized version of the drug supplied by Shire and is not launching its own generic at this time. The product supply agreement between the companies ends April 1, 2014. Teva stated U.S. sales of the brand and generic versions of Adderall XR totaled $2 billion in 2012. (Bloomberg 2/15/13)
US appeals court upholds patent on AstraZeneca's Seroquel XR
AstraZeneca announced that the US Court of Appeals for the Federal Circuit upheld an earlier ruling that the formulation patent on the extended-release version of Seroquel (quetiapine) is valid. The court determined that the patent, which was upheld last year by the District Court of New Jersey, had been infringed by Par's Anchen unit, Osmotica, Torrent and Mylan. AstraZeneca contends that its patent on the extended-release version of the drug is valid until 2017. (FirstWord 2/15/13)
Actavis reaches settlement with Mallinckrodt over Exalgo 32mg
Actavis and Mallinckrodt have settled patent litigation regarding Actavis' generic version of Mallinckrodt's Exalgo (hydromorphone hydrochloride) extended-release tablets in the 32mg strength. The companies settled litigation regarding the 8mg, 12mg and 16mg strengths in January. Under the terms of the settlement, Mallinckrodt granted Actavis a loyalty-free license to its U.S. patents on Exalgo, allowing Actavis to start selling a generic version of the 32mg strength in May 2014. Actavis believes it may be a "first applicant" to file an ANDA for the generic version of the 32mg strength of Exalgo and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. (DrugStoreNews 2/14/13, PRNewswire 2/15/13)
Gilead Settles Viread Patent Suit
Teva and Gilead agreed to settle a patent dispute over Viread, a treatment for HIV infection and chronic Hepatitis B, avoiding a trial that was scheduled to start February 19, Gilead said. Teva will be permitted to begin sales of a generic version of Viread on December 15, 2017, according to a statement released by Gilead. (Bloomberg 2/19/13)
Mylan and Biocon enter deal on generic analog insulins
Mylan and Biocon have a deal to develop and sell generic insulin-analog products. Under the terms of the deal, Mylan will have the rights to develop and market Biocon's Glargine, Lispro and Aspart, respectively generic versions of Sanofi's Lantus, Eli Lilly's Humalog and Novo Nordisk's NovoLog. "This collaboration builds off our existing successful partnership for generic biologics with Biocon and brings Mylan a portfolio of high-value insulin analog products," Mylan CEO Heather Bresch said. "This collaboration further expands and diversifies our pipeline of complex, difficult-to-manufacture products with strong future growth potential." (DrugStoreNews 2/20/13)
Ranbaxy resumes Atorvastatin production for U.S.
Ranbaxy announced it has restarted production of atorvastatin as it looks to resume supplies to U.S. market. In November last year Ranbaxy recalled its atorvastatin, the generic version of Pfizer's Lipitor, for select batches in the strengths of 10mg, 20mg and 40mg tablets from the U.S. market due to presence of foreign particles. Since then it has been working with the FDA to implement multiple corrective and preventive actions. (business-standard.com 2/25/13)
February 25, 2013
CMS Proposes 2014 Payment and Policy Updates
CMS has released their Medicare Plan Call letter which proposes payment and policy updates for Medicare Health & Drug Plans. Comments are due by March 1.
February 25, 2013
APRx Lawsuit Update with CVS-Caremark
American Pharmacies wins again as CVS fails to keep RICO suit out of court.
Industry News - February 8, 2013
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Focalin XR: Launch now expected in Q3 2013 by multiple suppliers.
Fosrenol: Potential launch in first quarter by Lupin, Mylan, Teva.
Lidoderm: Exclusive launch now expected in Q3 2013.
Oxycontin: Potential multi-supplier on 4/16/13.
Soriatane: Potential multi-supplier launch in Q2 2013.
Taclonex Ointment: Potential co-exclusive launch expected in first quarter with Sandoz and Perrigo.
Valcyte: Potential exclusive launch on 3/1/13.
RECENT LAUNCHES
Dr. Reddy's launches generic Clarinex Reditabs
Dr. Reddy's has launched desloratadine orally disintegrating tablets, a generic version of Merck's Clarinex Reditabs. The branded version of the drug had sales of approximately $5.3 million during the 12-month period that ended in November 2012, according to IMS Health. (DrugStoreNews 1/25/13)
Perrigo launches generic Olux-E Foam
Perrigo launched clobetasol emulsion propionate foam, a generic version of GlaxoSmithKline's Olux-E. The drug is used to treat moderate to severe dermatosis of the scalp. As the first company to file a regulatory approval application for the drug, Perrigo is entitled to 180 days in which to compete exclusively with GlaxoSmithKline's version. The drug has annual sales of $38 million, according to Symphony Health Solutions. (DrugStoreNews 2/4/13)
FDA approves generic Doxil
The FDA approved Sun's generic version of Johnson and Johnson's cancer drug Doxil in a move that could ease a months-long shortage that has threatened the lives of thousands of patients. Sun's product is the first generic version of Doxil, which was approved in 1995 and is used to treat ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma. Doxil fell into short supply after manufacturing problems at an outside contract manufacturer, Ben Venue Laboratories, a unit of Boehringer Ingelheim, suspended operations in November 2011 due to quality control problems. Last February, the FDA allowed for the temporary importation of Lipodox, which is made by Sun and contains the same active ingredient as Doxil. The agency said it intends to continue allowing the importation of Lipodox until Sun has made enough generic Doxil to meet demand. Late last month a federal judge approved a consent decree under which Ben Venue must bring its Bedford, Ohio facility into compliance with regulatory requirements or face fines and other penalties. Recent inspections found that poorly maintained equipment deteriorated to the point that it shed particles into injectable drugs, according to the FDA. (Reuters 2/4/13)
PRODUCT UPDATES
FDA approves OTC version of Oxytrol
The FDA approved Merck's nonprescription version of Oxytrol to treat overactive bladder in women ages 18 and older. The FDA stated the over-the-counter (OTC) version of Oxytrol would be available for women only and that the drug remained available to men by prescription. Oxytrol will be the first drug in its class to be sold OTC. Merck licensed exclusive rights to sell OTC Oxytrol from Actavis and expects the OTC patch to be available in the fall. The FDA decided to approve the OTC version, based on the results of nine studies of women that demonstrated that consumers can understand the information on the label, properly determine whether the product is right for them, and use the drug appropriately. (Reuters 1/28/13)
Merck wins court ruling blocking generics of Zetia and Vytorin
A U.S. Court of Appeals upheld the validity of Merck's patent on Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin), affirming a lower court ruling and preventing Mylan from marketing a generic version of these drugs until April 2017. Merck previously revealed that it is also suing Impax and Actavis over their plans to sell generic versions of Vytorin, although those cases were put on hold pending the outcome of the Mylan case. Zetia and Vytorin had combined U.S. sales of approximately $2 billion in 2012. (FirstWord 2/8/13)
INDUSTRY UPDATES
Watson changes name to Actavis
Watson announced it has formally changed its name to Actavis. The generic drug manufacturer, now the world's third largest, announced its plan to change the name last year after it acquired Actavis. The combined company expects combined 2012 sales to exceed $8 billion."Today marks an historic day for Actavis and a milestone in our evolution into a global pharmaceutical leader," Actavis president and CEO Paul Bisaro said. "While we have been operating as one company since last year, today we unite all of our 17,000 employees under a single name, trademarked and protected around the world." (DrugStoreNews 1/25/13)
Survey: 1-in-5 Americans received flu shots at a retail pharmacy
Most Americans who reported getting a flu shot in the past season received that vaccination in their physician's office. However, approximately 20% received their flu shot at a retail pharmacy and 12.6% at a walk-in clinic, according to an Ipsos Public Affairs poll. That suggests that as many as 18.5 million flu shots were administered to adults at retail pharmacy and another 11.7 million to adults at walk-in clinics. (DrugStoreNews 2/4/13)
January 28, 2013
Compounding Survey Results
The Florida Board of Pharmacy has released a report on the compounding survey that all licensed Florida pharmacies were required to complete in December.
January 17, 2013
FL BOP Compounding Call
The Florida Board of Pharmacy held a Compounding Committee meeting conference call on Wednesday, January 16 at 9:30 a.m.
Click here to hear a recording of the call
January 18, 2013
In Memoriam - Jane Davies
PPSC extends its condolences to John Davies on the recent loss of his wife, Jane. John has been a PPSC Board member since 1986 and is the owner of Orlando Pharmacy.
Make a donation in Jane's memory
Industry News - January 16, 2013
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Atacand: Launch originally was expected 12/4/12, but has now been delayed until January or February. The generic is expected to be launched by multiple suppliers.
Taclonex Ointment: Potential launch expected 1/1/13, by multiple suppliers including G&W and Perrigo.
RECENT LAUNCHES
Generic Dilantin Infatabs launches
Mylan announced that it received final FDA approval for its Phenytoin Chewable Tablets USP 50 mg, a generic version of Pfizer's Dilantin Infatabs. Pfizer's product is indicated for the control of generalized tonic-clonic (i.e., grand mal) and complex partial (i.e., psychomotor, temporal lobe) seizures, and prevention and treatment of seizures occurring during or following neurosurgery. Greenstone, Pfizer's generic division, launched an authorized generic of the brand product. Dilantin Infatabs had U.S. sales of approximately $16.5 million for the 12 months ending September 30, 2012, according to IMS Health. (PRNewswire 12/28/12, DrugStoreNews 1/4/13)
Generic Maxalt and Maxalt MLT launches
The FDA approved Mylan's ANDAs for Rizatriptan Benzoate orally disintegrating tablets, 5mg (base) and 10mg (base), and Rizatriptan Benzoate tablets, 5mg (base) and 10mg (base),the generic versions of Maxalt MLT Tablets and Maxalt Tablets respectively. The generic products are indicated as migraine therapy for adults with or without aura. The FDA granted Mylan 180 days of marketing exclusivity for Rizatriptan Benzoate Orally Disintegrating Tablets, 5mg (base) and 10mg (base). Apotex and Breckenridge also launched their generic versions of Maxalt, while Par is the authorized generic for both formulations. (PBR Staff Writer 1/3/13, PBR Staff Writer 12/31/12, DrugStoreNews 1/3/13, Apotex Press Release 1/2/13)
Generic Propecia launches
Dr. Reddy's announced the launch of finasteride tablets 1mg, a generic version of Merck's Propecia. As the first company to successfully file for approval of a generic version of the drug, Dr. Reddy's is entitled to 180 days of market exclusivity in which to compete directly with the branded version. Propecia had sales of approximately $136 million during the 12-month period that ended in October 2012, according to IMS Health. (DrugStoreNews 1/3/13)
Generic Lysteda launches
The FDA approved Watson's tranexamid acid for heavy menstrual bleeding, a generic version of Ferring's Lysteda. Ferring has filed suit against Watson, alleging that the generic drug infringes two of its patents. In additional, Prasco has launched the authorized generic. Lysteda had sales of appoximately $25 million during the 12-month period that ended in November, according to IMS Health. (DrugStoreNews 1/4/13, DrugStoreNews 1/7/13)
Generic Opana ER launches
Impax announced that it commenced shipment of Oxymorphone Hydrochloride Extended-Release Tablets, through its Global division. The drug is a generic version of Endo's Opana ER. In June 2010, Impax reached an agreement with Endo and Penwest to settle U.S. patent litigation with regard to the production and sale of its FDA-approved Oxymorphone Hydrochloride Extended-Release Tablets. Under the terms of the settlement, Endo agreed to grant Impax a license to sell Impax's approved product on January 1, 2013. (PharmaLive 1/7/13)
PRODUCT UPDATES
Wockhardt Launches Generic Version of Anti-convulsant Drug Lamictal XR
(PharmaLive1/9/13)
PARSIPPANY, N.J. and MUMBAI, India - Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 25mg, 50mg, 100mg, 200mg and 300mg extended release tablets of Lamotrigine, which is used in treatment of epilepsy. Lamotrigine is the generic name for the brand Lamictal XR®, marketed in the United States by Glaxo SmithKline. Wockhardt is launching the product immediately and will be amongst the earliest generic versions of this product in the market.
Generic Lamictal XR launches
The FDA has approved Wockhardt's lamotrigine extended-release tablets, a generic version of GlaxoSmithKline's Lamictal XR. The U.S. market for the drug is approximately $250 million, according to IMS Health. (Pharmalive 1/9/13, DrugStoreNews 1/10/13)
Generic Duetact launches
Sandoz received final FDA approval for and commenced shipping pioglitazone, a generic equivalent for Takeda's Duetact. Duetact is an oral antihyperglyemic agent that acts primarily by decreasing insulin resistance, and is used in the management of type 2 diabetes. Sandoz has 180 days of marketing exclusivity. Duetact had estimated total U.S. annual sales of approximately $30 million. (Press Release 1/14/13)
INDUSTRY UPDATES
FDA approves 39 new drugs in 2012
The FDA approved 39 new drugs in 2012, with 8 approved in December alone, marking the largest increase in 16 years. The wave of approvals positions pharmaceutical manufacturers to see large gains after billions in losses in recent years to generic competition due to patent expirations. In comparison, 30 new drugs were approved in 2011 and only 21 in 2010. The year 2012 saw the highest number of approvals since 1996, when 53 so-called new molecule entities received approval. (Reuters 12/31/12)
January 14, 2013
Fiscal Cliff Update
NCPA has provided an update on the Fiscal Cliff and how it will impact community pharmacies.
January 14, 2013
OutcomesMTM CMR Changes
Many changes to the Comprehensive Medication Review (CMR) service are taking effect in 2013. OutcomesMTM & PPSC want to make sure you are prepared.
Industry News - December 28, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Atacand: Launch originally was expected 12/4/12, but has now been delayed until January or February. The generic is expected to be launched by multiple suppliers.
Duetact: Launch was expected 12/14/12 exclusively by Sandoz, with no authorized generic.
Lysteda: Launch by Apotex has been delayed due to audit. Uncertain whether a launch by Watson and Prasco (the authorized generic) will occur.
Lamictal XR: Launch originally expected 11/29/12. Now delayed due to labeling issues. Potential launch by multiple suppliers in December.
Maxalt/Maxalt MLT: Potential launch expected 12/29/12.
Opana: Potential launch expected 1/1/13 by Global, with Endo as the authorized generic. There may be a delay due to complaints by the brand company regarding the crushable form of the generic.
Propecia: Potential launch expected 1/1/13.
Taclonex Ointment: Potential launch expected 1/1/13, by multiple suppliers including G&W and Perrigo.
RECENT LAUNCHES
FDA approves generic Qualaquin
Mylan announced that it received final FDA approval for its ANDA for Quinine Sulfate Capsules USP, 324 mg, the generic version of Mutual's Qualaquin. Qualaquin is an antimalarial drug indicated only for the treatment of uncomplicated Plasmodium falciparum malaria. Various versions of the drug had U.S. sales of approximately $31.9 million for the 12 months ending September 30, 2012, according to IMS Health. (PRNewswire 12/19/12, DrugStoreNews 12/18/12)
PRODUCT UPDATES
U.S. appeals court upholds Crestor patent, blocking generics until 2016
AstraZeneca announced that a U.S. appeals court upheld an earlier district court ruling that the substance patent protecting Crestor (rosuvastatin) is valid and enforceable. The company noted that applications to market generic versions of the product from Apotex, Aurobindo, Cobalt, Glenmark, Mylan, Par, Sandoz, Sun, Teva and Torrent are not to be approved by the FDA until the patent expires in 2016. However, AstraZeneca stated the manufacturers may seek a rehearing of the case or a review by the US Supreme Court. In their lawsuit, while all the generic companies excluding Apotex conceded that their versions infringed upon Crestor's patent, they claimed that the patent covered an obvious variation of earlier compounds. They also alleged that AstraZeneca and patent partner Shionogi withheld important information about the medication from the patent office. Crestor had sales of $2.2 billion through the first nine months of 2012. (FirstWord 12/17/12)
FDA denies Merck request to block generic Nasonex
The FDA denied Merck's petition asking the agency not to approve applications by generic drug manufacturers to sell proposed generic versions of Nasonex. Merck argued the FDA shouldn't approve any generic that has a different formulation than Nasonex. The FDA denial of Merck's petition follows a federal court ruling earlier this year finding that Apotex's proposed generic of Nasonex doesn't violate a Merck patent for the drug. Merck has appealed that patent ruling. Both developments remove some obstacles to the market entry of competing generic versions of Nasonex before patent expiration in 2018. The drug, which Merck obtained in its 2009 purchase of Schering-Plough, generated $960 million in sales for the first nine months of 2012. (Fox Business 12/20/12)
INDUSTRY UPDATES
Takeda sells URL Pharma to Sun
Takeda is selling its USA-based URL Pharma generic business, excluding Colcrys, to Sun Pharmaceutical's Caraco unit. Takeda only bought URL in June, in an $800 million deal that was principally driven by the desire to get access to Colcrys (colchicine). Net sales for the gout treatment reached $155 million from June 1 to September 30 this year. The Japan-headquartered firm is now divesting the non-Colcrys assets of URL before the Takeda buy. Financial details have not been disclosed and Caraco will now take over the reins, subject to regulatory approvals. (PharmaTimes 12/18/12)
December 19, 2012
Medicaid HMO Pharmacy Network Closure Litigation Update
Settlement letter from AHCA clarifying Medicaid pharmacy patients are free to access the Medicaid pharmacy care provider and the Medicaid health care plan of their choice.
Industry News - December 12, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Atacand: Launch originally was expected 12/4/12, but has now been delayed until January or February. The generic is expected to be launched by multiple suppliers.
Duetact: Potential launch expected 12/14/12 exclusively by Sandoz, with no authorized generic.
Lysteda: Launch by Apotex has been delayed due to audit. Uncertain whether a launch by Watson and Prasco (the authorized generic) will occur.
Lamictal XR: Launch originally expected 11/29/12. Now delayed due to labeling issues. Potential launch by multiple suppliers in December.
Maxalt/Maxalt MLT: Potential launch expected 12/29/12.
Opana: Potential launch expected 1/1/13 by Global, with Endo as the authorized generic. There may be a delay due to complaints by the brand company regarding the crushable form of the generic.
Propecia: Potential launch expected 1/1/13.
Taclonex Ointment: Potential launch expected 1/1/13, by multiple suppliers including G&W and Perrigo.
RECENT LAUNCHES
Lupin launches generic Tricor
Lupin received final FDA approval and has launched its Fenofibrate Tablets, 48mg and 145mg, the AB rated generic of Abbott's Tricor.a and severe Hypertriglyceridemia. Tricor had sales of $1.26 billion during the 12-month period that ended in June, according to IMS Health. (CNBC 11/20/12, DrugStoreNews 11/21/12)
Generic Atacand HCT launches
Mylan received final FDA approval for its ANDA for Candesartan Cilexetil and Hydrochlorothiazide tablets, 16/12.5mg, 32/12.5mg and 32/25mg, the generic version of AstraZeneca's Atacand HCT. Mylan was the first company to have submitted a substantially complete ANDA to the FDA containing a Paragraph IV certification for Candesartan Cilexetil and hydrochlorothiazide tablets, 32/25 mg, and was awarded 180 days of generic marketing exclusivity for this strength. Apotex also received FDA approval and has launched the 16/12.5mg and 32/12.5mg strengths. Par announced that it had entered a supply and distribution agreement with AstraZeneca to distribute an authorized generic version of Atacand HCT in all three strengths. Atacand HCT had U.S. sales of $56.3 million for the 12 months ending September 30, 2012, according to IMS Health. (PharmaBiz 12/7/12, Apotex Press Release 12/5/12, DrugStoreNews 12/6/12)
PRODUCT UPDATES
FDA approves generic Luxiq Foam
Perrigo announced that Cobrek, with which it is partnering, received FDA approval for betamethasone validate foam 0.12%, a generic version of GlaxoSmithKline's Luxiq foam. Perrigo has manufactured the product and is preparing to commence commercial shipments on January 15, 2013. Cobrek was first to file, making the product eligible for 180 days of marketing exclusivity. The branded version of the drug has annual sales of approximately $40 million, according to Perrigo. (DrugStoreNews 11/28/12, Perrigo Press Release 11/27/12)
INDUSTRY UPDATES
Generic drugs market predicted to reach $127.8 billion in 2013
The value of the world prescription generic drug industry stands at $110.8 billion in 2011 and is forecasted to grow to $127.8 billion in 2013. If a more general definition of off-patent medicines is used to define generics, some estimates put the size of the industry at over $150 billion, according to a new report from business information group Visiongain. U.S. generic drug sales have more than tripled since 2000. Sales of generics account for approximately 70% of the prescriptions dispensed in the U.S. This percentage is likely to increase as novel branded drugs face further competition from generic products. Other countries will experience similar trends, the report finds. (ThePharmaLetter 11/21/12)
Ranbaxy halts manufacturing of Atorvastatin
Ranbaxy will temporarily stop manufacturing its generic atorvastatin. On November 9, 2012 the company announced a voluntary recall of some lots of atorvastatin due to possible contamination with glass particles. An FDA statement said that Ranbaxy will discontinue making the drug "until it has thoroughly investigated the cause of the glass particulates and remedied the problem." To date, no reports of harm from the contamination have been received by the FDA. Both FDA and Ranbaxy believe there is only a low likelihood that there will be adverse events related to the problem. The FDA stated it does not anticipate a shortage of atorvastatin as a result of the recall, but that it "is working with other manufacturers of atorvastatin to ensure adequate market supply." (Forbes 11/30/12)
Qualitest issues voluntary recall of Hydrocodone Bitartrate and Acetaminophen Tablets
Qualitest issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. It is possible that a number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for acetaminophen. The recall affects lots that were distributed from February 20, 2012 to November 19, 2012 and includes bottles with 30 to 1,000 count tablets. (PharmaLive 12/6/12, MedPage Today 12/8/12)
December 5, 2012
FL BOP Emergency Rule Compounding Survey
All licensed Florida pharmacies are required to complete the FL BOP's emergency rule mandatory compounding survey by December 11, 2012.
Click here to read more
November 14, 2012
FL Pharmacists Head to State Capitol
Pharmacists from across the state of Florida visited the State Capitol on Thursday, November 8 to present issues of urgency facing independent pharmacies today.
November 7, 2012
Media Release: Ameridose Halts Shipments
State Regulators reach agreement with Ameridose halting company's shipments to Florida.
10/31/2012
PPSC Signs Agreement with Mevesi
PPSC members can now utilize Mevesi's data tools to help build their businesses and manage their pharmacies.
Click here to read more Attachment: PPSC_Mevesi.pdf
10/22/2012
PPSC partners with RxSelect
PPSC Bronze members are now eligible for discounts on third party contracting, electonic reconciliation, and audit protection.
Attachment: PPSC_PPOK.pdf
Industry News - October 19, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Arthrotec: Potential launch in mid-October with possible coexclusivity with Teva and Watson.
Focalin XR: Potential launch expected 10/23/12 by multiple suppliers. (25mg and 30mg delayed until 2014.)
Revatio: Launch by multiple suppliers now delayed until approximately 10/27/12.
RECENT LAUNCHES
Apotex launches generic Evoxac
Apotex has been awarded 180 days of marketing exclusivity and has commenced commercial launch of Cevimeline Capsules, the AB-rated generic to Daiichi Sankyo's Evoxac. Annual sales for Evoxac were approximately $62.4 million, for the period that ended June 2012, according to IMS Health. (Apotex Press Release 10/8/12)
PRODUCT UPDATES
FDA withdraws approval of Teva's generic of Wellbutrin XL 300mg
The FDA has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) 300mg, manufactured by Impax and Teva, is not therapeutically equivalent to Wellbutrin XL 300mg. The FDA said that when it approved five generic versions of the antidepressant in the 300mg strength, each of these generics was approved based on bioequivalence studies comparing the 150mg strength of the products with Wellbutrin XL 150mg. Studies were not performed directly on the 300mg strength of the products, but rather, bioequivalence study results were extrapolated from the 150mg product to the 300mg product. "[The] FDA has determined that this approach is no longer appropriate to establish bioequivalence study results of 300mg bupropion hydrochloride extended-release tablets to Wellbutrin XL 300mg, and the agency is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products," the FDA said in a statement. The FDA said the 150mg Budeprion XL drug marketed by Teva, as well as other generic extended-release Wellbutrin products made by other drug manufacturers, are not impacted. (Wall Street Journal 10/3/12, DrugStoreNews 10/5/12)
Mylan sues FDA for approval of generic Diovan
Mylan sued the FDA for approval to sell a generic version of Novartis' Diovan after a competitor failed to get the drug on the market in time. Mylan stated Ranbaxy forfeited its right to six-month exclusivity to sell the generic drug by not winning FDA approval. Mylan argues the FDA's refusal to approve its sale of the drug is arbitrary and capricious and an abuse of discretion. "Ranbaxy failed to receive tentative approval prior to the statutory 30-month forfeiture deadline, and no statutory exception to forfeiture applies," Mylan said in its complaint. Diovan generated $5.7 billion in revenue around the world last year, according to Novartis' annual report. (Bloomberg 10/4/12)
Mylan announces settlement agreement for generic version of Orapred ODT
Mylan announced that it has entered into a settlement agreement with Shionogi and CIMA Labs that will resolve patent litigation related to Prednisolone Sodium Phosphate Orally Disintegrating Tablets (ODT), the generic version of Shionogi's Orapred ODT. According to the terms of the settlement, Mylan will be licensed to sell its Prednisolone Sodium Phosphate ODT product on April 1, 2014, or earlier under certain circumstances. Other details of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. Mylan believes it was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification with the FDA for Prednisolone Sodium Phosphate ODT, and anticipates that it will be entitled to 180 days of generic market exclusivity. This product had U.S. sales of $33.1 million for the 12 months ending June 30, 2012, according to IMS Health. (FirstWord 10/10/12)
Industry News - October 3, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Arthrotec: Potential launch in mid-October with possible coexclusivity with Teva and Watson.
Diovan: Launch now expected on 10/17/12 by multiple suppliers.
Focalin XR: Potential launch expected 10/23/12 by multiple suppliers. (25mg and 30mg delayed until 2014.)
Lescol XL: Potential exclusive launch expected sometime in September by Par.
Revatio: Launch by multiple suppliers now delayed until approximately 10/27/12.
RECENT LAUNCHES
Sandoz launches authorized generic of Diovan HCT
Sandoz announced the launch of an authorized generic version of Novartis' Diovan HCT (valsartan and hydrochlorothiazide tablets. Novartis will continue marketing the branded version of the drug, which had sales of $2.3 billion in 2011 together with Diovan (valsartan). An authorized generic is a branded drug sold under its generic name at a reduced price. (DrugStoreNews 9/24/12)
Mylan launches generic version of Diovan HCT Tablets
Mylan announced that it received final FDA approval for its ANDA for Valsartan and Hydrochlorothiazide Tablets, the generic version of Novartis' Diovan HCT Tablets. Various versions of the drug had sales of approximately $1.6 billion during the 12-month period that ended in June, according to IMS Health. (PRNewswire 9/21/12, DrugStoreNews 9/21/12)
PRODUCT UPDATES
Watson issues voluntary nationwide recall of Hydrocodone Bitartrate and Acetaminophen Tablets
Watson issued a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, USP 10 mg/500 mg. A customer complaint was received for tablets that were thicker and of a darker shade than the other tablets. It is possible that some tablets from lots 519406A and 521759A exceed the weight specification and may contain higher than indicated amounts of the ingredients Hydrocodone Bitartrate and/or Acetaminophen. (PRNewswire 9/25/12)
INDUSTRY UPDATES
Generic drugs saved almost $2 billion in 2011
Generic prescription drugs saved $193 billion in drug costs in the U.S. last year, according to a report produced by the Generic Pharmaceutical Association. The fourth annual report, which was produced with data from IMS Health, showed that savings were up from $158 billion in 2010 and $60 billion in 2002. Nearly 80% of the prescriptions dispensed in the U.S. in 2011 were generics. The report showed that consumers opted for the generic version of a drug 94% of the time. It also noted that drugs for heart conditions and central nervous system disorders, such as depression and convulsions, accounted for 57% of the annual savings. (Canadian Healthcare Network 9/17/12)
Industry News - September 10, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Cipro OS: Potential exclusive launch by Lupin expected late August.
Comtan: Potential exclusive launch expected by Wockhardt due to a settlement agreement on 9/30/12.
Detrol LA: Launch originally expected 9/25/12, but now delayed to 2014.
Diovan/Diovan HCT: Launch expected 9/21/12, with coexclusivity.
Exforge: Potential launch expected 9/21/12, with coexclusivity.
Lescol XL: Potential exclusive launch expected sometime in September by Par.
Revatio: Launch expected by multiple suppliers with the expiration of pediatric exclusivity on 9/27/12.
PRODUCT UPDATES
Teva loses Alimta patent appeal
Teva has lost its appeal against Eli Lilly in the patent infringement case over its lung cancer drug Alimta. The U.S. Court of Appeals ruled that Eli Lilly's patents are valid through 2017, affirming the prior district court ruling. Teva had argued that Eli Lilly had patented a compound that was little different from what was covered by two earlier patents. The three-judge panel said the lower court was correct to rule that the 2017 patent is distinct from the earlier inventions. Alimta had $2.5 billion in annual sales in 2011, making it Eli Lilly's third largest product. (Globes 8/26/12)
FDA approves Teva version of Amgen's Neupogen
The FDA approved Teva’s version of Amgen’s Neupogen, which faces the expiration of its U.S. patent next year. As part of the settlement of patent litigation, Teva agreed last year to refrain from launching its versions of Neupogen and Neulasta in the United States until November 2013. Amgen's U.S. sales of Neupogen were $959 million last year, while sales of Neulasta were $3 billion. The FDA stated Teva's drug, called tbo-filgrastim, stimulates bone marrow to increase production of white blood cells, which may help cancer patients recover more quickly from the side effects of chemotherapy. Teva received its approval under a standard U.S. Food and Drug Administration review. (Reuters 8/30/12)
Impax settles litigation relating to Renvela and Renagel
Impax announced that it has reached agreement with Genzyme to settle pending U.S. litigation with regard to the production and sale of generic formulations of Renvela (sevelamer carbonate 800mg tablets and oral suspension) and Renagel tablets (sevelamer hydrochloride 400mg and 800mg tablets). Under the terms of the settlement, Genzyme has agreed to grant Impax a license to sell a generic version of Renvela tablets on March 16, 2014 or earlier under certain circumstances. Genzyme has also agreed to grant Impax a license to sell a generic version of Renvela for oral suspension and of Renagel on September 16, 2014 or earlier under certain circumstances.
Impax believes that it is the first to file an ANDA with a paragraph IV certification with respect to the sevelamer carbonate 800mg tablet product, and expects to be entitled to 180-days of market exclusivity. (FirstWord 9/5/12)
Mylan and Pfizer settle patent suit over generic Detrol LA
Mylan announced it settled litigation with Pfizer over Detrol LA. Under the terms of the settlement, Mylan can start selling its generic versions on January 1, 2014, or earlier under some limited circumstances, but not after March 1, 2014, if the FDA approves. The settlement with Mylan comes days after Pfizer resolved a similar dispute with Impax late last month. (Reuters 9/10/12)
Industry News - August 24, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Cipro OS: Potential exclusive launch by Lupin expected late August.
Comtan: Potential exclusive launch expected by Wockhardt due to a settlement agreement on 9/30/12.
Detrol LA: Launch originally expected 9/25/12, but now delayed to 2014.
Diovan/Diovan HCT: Launch expected 9/21/12, with coexclusivity.
Exforge: Potential launch expected 9/21/12, with coexclusivity.
Lescol XL: Potential exclusive launch expected sometime in September by Par.
Revatio: Launch expected by multiple suppliers with the expiration of pediatric exclusivity on 9/27/12.
PRODUCT UPDATES
Teva loses Alimta patent appeal
Teva has lost its appeal against Eli Lilly in the patent infringement case over its lung cancer drug Alimta. The U.S. Court of Appeals ruled that Eli Lilly's patents are valid through 2017, affirming the prior district court ruling. Teva had argued that Eli Lilly had patented a compound that was little different from what was covered by two earlier patents. The three-judge panel said the lower court was correct to rule that the 2017 patent is distinct from the earlier inventions. Alimta had $2.5 billion in annual sales in 2011, making it Eli Lilly's third largest product. (Globes 8/26/12)
FDA approves Teva version of Amgen's Neupogen
The FDA approved Teva’s version of Amgen’s Neupogen, which faces the expiration of its U.S. patent next year. As part of the settlement of patent litigation, Teva agreed last year to refrain from launching its versions of Neupogen and Neulasta in the United States until November 2013. Amgen's U.S. sales of Neupogen were $959 million last year, while sales of Neulasta were $3 billion. The FDA stated Teva's drug, called tbo-filgrastim, stimulates bone marrow to increase production of white blood cells, which may help cancer patients recover more quickly from the side effects of chemotherapy. Teva received its approval under a standard U.S. Food and Drug Administration review. (Reuters 8/30/12)
Impax settles litigation relating to Renvela and Renagel
Impax announced that it has reached agreement with Genzyme to settle pending U.S. litigation with regard to the production and sale of generic formulations of Renvela (sevelamer carbonate 800mg tablets and oral suspension) and Renagel tablets (sevelamer hydrochloride 400mg and 800mg tablets). Under the terms of the settlement, Genzyme has agreed to grant Impax a license to sell a generic version of Renvela tablets on March 16, 2014 or earlier under certain circumstances. Genzyme has also agreed to grant Impax a license to sell a generic version of Renvela for oral suspension and of Renagel on September 16, 2014 or earlier under certain circumstances.
Impax believes that it is the first to file an ANDA with a paragraph IV certification with respect to the sevelamer carbonate 800mg tablet product, and expects to be entitled to 180-days of market exclusivity. (FirstWord 9/5/12)
Mylan and Pfizer settle patent suit over generic Detrol LA
Mylan announced it settled litigation with Pfizer over Detrol LA. Under the terms of the settlement, Mylan can start selling its generic versions on January 1, 2014, or earlier under some limited circumstances, but not after March 1, 2014, if the FDA approves. The settlement with Mylan comes days after Pfizer resolved a similar dispute with Impax late last month. (Reuters 9/10/12)
UPCOMING POTENTIAL LAUNCHES
Cipro OS: Potential exclusive launch by Lupin expected late August.
Comtan: Potential exclusive launch expected by Wockhardt due to a settlement agreement on 9/30/12.
Detrol LA: Launch originally expected 9/25/12, but now delayed to 2014.
Diovan/Diovan HCT: Launch expected 9/21/12, with coexclusivity.
Exforge: Potential launch expected 9/21/12, with coexclusivity.
Lescol XL: Potential exclusive launch expected sometime in September by Par.
Revatio: Launch expected by multiple suppliers with the expiration of pediatric exclusivity on 9/27/12.
PRODUCT UPDATES
Teva loses Alimta patent appeal
Teva has lost its appeal against Eli Lilly in the patent infringement case over its lung cancer drug Alimta. The U.S. Court of Appeals ruled that Eli Lilly's patents are valid through 2017, affirming the prior district court ruling. Teva had argued that Eli Lilly had patented a compound that was little different from what was covered by two earlier patents. The three-judge panel said the lower court was correct to rule that the 2017 patent is distinct from the earlier inventions. Alimta had $2.5 billion in annual sales in 2011, making it Eli Lilly's third largest product. (Globes 8/26/12)
FDA approves Teva version of Amgen's Neupogen
The FDA approved Teva’s version of Amgen’s Neupogen, which faces the expiration of its U.S. patent next year. As part of the settlement of patent litigation, Teva agreed last year to refrain from launching its versions of Neupogen and Neulasta in the United States until November 2013. Amgen's U.S. sales of Neupogen were $959 million last year, while sales of Neulasta were $3 billion. The FDA stated Teva's drug, called tbo-filgrastim, stimulates bone marrow to increase production of white blood cells, which may help cancer patients recover more quickly from the side effects of chemotherapy. Teva received its approval under a standard U.S. Food and Drug Administration review. (Reuters 8/30/12)
Impax settles litigation relating to Renvela and Renagel
Impax announced that it has reached agreement with Genzyme to settle pending U.S. litigation with regard to the production and sale of generic formulations of Renvela (sevelamer carbonate 800mg tablets and oral suspension) and Renagel tablets (sevelamer hydrochloride 400mg and 800mg tablets). Under the terms of the settlement, Genzyme has agreed to grant Impax a license to sell a generic version of Renvela tablets on March 16, 2014 or earlier under certain circumstances. Genzyme has also agreed to grant Impax a license to sell a generic version of Renvela for oral suspension and of Renagel on September 16, 2014 or earlier under certain circumstances.
Impax believes that it is the first to file an ANDA with a paragraph IV certification with respect to the sevelamer carbonate 800mg tablet product, and expects to be entitled to 180-days of market exclusivity. (FirstWord 9/5/12)
Mylan and Pfizer settle patent suit over generic Detrol LA
Mylan announced it settled litigation with Pfizer over Detrol LA. Under the terms of the settlement, Mylan can start selling its generic versions on January 1, 2014, or earlier under some limited circumstances, but not after March 1, 2014, if the FDA approves. The settlement with Mylan comes days after Pfizer resolved a similar dispute with Impax late last month. (Reuters 9/10/12)
Industry News - August 13, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Actoplus MET:
Launch expected 12/14/12 with co-exclusivity.
Actos: Launch expected 8/17/12 by multiple suppliers including Watson, Ranbaxy, Mylan, and Teva.
Cipro OS: Potential exclusive launch by Lupin expected late August.
Comtan: Potential exclusive launch expected by Wockhardt due to a settlement agreement on 9/30/12.
Detrol: Launch expected 9/25/12.
Diovan/Diovan HCT: Launch expected 9/21/12, with coexclusivity.
Lidoderm: Launch was originally expected in July but has been delayed until January 2013.
Lescol XL: Potential exclusive launch expected sometime in September by Par.
Revatio: Launch expected by multiple suppliers with the expiration of pediatric exclusivity on 9/27/12.
Xopenex: Launch expected 8/20/12 by Watson, with Prasco as the authorized generic.
RECENT LAUNCHES
Sandoz launches generic Dovonex Cream
On August 1, Sandoz received final FDA approval and commenced shipping their AB-rated generic for Leo’s Dovonex cream (calcipotriene). Dovonex had sales of approximately $118.8 million during the 12-month period that ended in May, according to IMS Health. Dovonex is a synthetic vitamin D3 derivative, for topical dermatological use. (Press Release 8/3/12, DrugStoreNews 8/6/12)
Generic Singulair launched
On August 3, several generic suppliers received final FDA approval and commenced shipping their AB-rated generic versions of Merck’s Singulair chewable tablets and immediate release (IR) tablets (montelukast sodium). Singulair is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.Annual sales of the brand IR tablets were nearly $3.5 billion and sales of Singulair chewable tablets were approximately $1.1 billion, for the twelve months ending March 2012. The FDA stated it approved versions of the tablet and chewable tablet formulations of the drug made by Apotex, Aurobindo, Endo, Kudco, Mylan, Roxane, Sandoz, Teva and Torrent. Teva also received approval for the oral granule formulation. (Zee News 8/6/12, DrugStoreNews 8/6/12)
PRODUCT UPDATES
Watson confirms Epiduo Gel patent challenge
Watson confirmed that it filed an ANDA with the FDA seeking approval to market adapalene and benzoyl peroxide Gel, a generic version of Galderma’s Epiduo Gel. Epiduo is a topical ointment prescription drug that combines a retinoid (adapalene) and an antimicrobial (benzoyl peroxide) for the treatment of acne vulgaris in people who are at least 12 years old. Galderma filed suit against Watson on July 27, 2012 seeking to prevent Watson from commercializing its generic prior to the expiration of certain U.S. patents. Epiduo Gel had sales of approximately $199 million during the 12-month period that ended in March, according to IMS Health. (sacbee.com 7/31/12, DrugStoreNews 7/30/12)
Watson confirms Xopenex HFA patent challenge
Watson confirmed that it filed an ANDA with the FDA seeking approval to market Levalbuterol Tartrate Inhalation Aerosol, a generic version of Sunovion's Xopenex HFA. Xopenex HFA is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease. Sunovion filed suit against Watson on July 27, 2012 seeking to prevent Watson from commercializing its ANDA product prior to the expiration of certain U.S. patents. Xopenox HFA had sales of approximately $148 million during the 12-month period that ended in March, according to IMS Health data. (FirstWord 7/31/12, DrugStoreNews 7/30/12)
INDUSTRY UPDATES
Report: Generic drugs saved $193 billion in 2011
A report from the Generic Pharmaceutical Association (GPhA) suggests that use of generic drugs has reduced U.S. healthcare spending by more than $1 trillion over the past decade, including $193 billion in 2011 alone. That amount was up 22 percent from the $158 billion in savings from generics in 2010, and was more than three times the $60 billion in savings in 2002, the report states. The report also notes that using generic versions of pricier brand prescription drugs now saves the country about $1 billion every other day. Last year, nearly 80 percent of the 4 billion prescriptions dispensed in the U.S. were generic drugs, but accounted for only 27 percent of total U.S. spending on prescription medications. In categories where both brand and generic drugs are available, consumers opted for the generic version 94 percent of the time last year. According to the report, drugs for cardiovascular conditions and disorders of the central nervous system accounted for 57 percent of the annual savings. (Associated Press 8/2/12, FirstWord 8/2/12)
August 5, 2012
Urgent Independent Pharmacy Meeting - Tampa, FL
Pharmacists stand up for your patients and profession! Join us for an urgent pharmacy meeting this Sunday in Tampa.
Industry News - July 30, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Actoplus MET: Launch expected 12/14/12 with co-exclusivity.
Actos: Launch expected 8/17/12 by multiple suppliers including Watson, Ranbaxy, Mylan, and Teva.
Cipro OS: Potential exclusive launch by Lupin expected late August.
Comtan: Potential exclusive launch expected by Wockhardt due to a settlement agreement on 9/30/12.
Diovan/Diovan HCT: Launch expected 9/21/12, with coexclusivity.
Lidoderm: Launch was originally expected in July but has been delayed until January 2013.
Lescol XL: Potential exclusive launch expected sometime in September by Par.
Revatio: Launch expected by multiple suppliers with the expiration of pediatric exclusivity on 9/27/12.
Singulair: All formulations are expected to launch 8/3/12 by multiple suppliers including Dr. Reddy’s, Mylan, Teva, Endo, and Sandoz.
Xopenex: Launch expected 8/20/12 by Watson.
RECENT LAUNCHES AND APPROVALS
Watson receives approval for generic Arthrotec
Watson announced that the FDA approved a subsidiary's application for diclofenac sodium and misoprostol delayed-release tablets, a generic version of G.D. Searle's Arthrotec. Arthrotec is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. Arthrotec had sales of approximately $130 million during the 12-month period that ended in May, according to IMS Health data. Watson plans to launch the product in the fourth quarter of 2012. (DrugStoreNews 7/12/12, PharmaLive 7/12/12)
FDA approves generic Plan B One-Step
Watson announced the approval of Next Choice One Dose (levonorgestrel) tablets in the 1.5-mg strength, a generic version of Teva’s Plan B One-Step. The drug is an emergency contraceptive used to prevent pregnancy following unprotected sex or contraceptive failure. Plan B One-Step had sales of approximately $88 million during the 12-month period that ended in March, according to IMS Health. Watson plans to launch immediately. (DrugStoreNews 7/13/12, FirstWord 7/13/12)
PRODUCT UPDATES
Actavis receives tentative approval for generic Intuniv
Actavis announced the FDA granted tentative approval to guanfacine extended-release tablets, a generic version of Shire's Intuniv. Tentative approval means a generic drug meets the basic regulatory requirements for final FDA approval, but the FDA can't approve it as the patents covering the brand version have not yet expired. Actavis stated it was likely the first company to file an application for generic Intuniv with a paragraph IV certification, a legal assertion that one or more patents covering Intuniv are invalid, unenforceable or not in danger of being infringed. Intuniv had sales of approximately $342 million during the 12-month period that ended in March, according to IMS Health. (DrugStoreNews 7/15/12)
Pfizer stops Teva selling generic Lyrica
A U.S. district court ruled in favor of Pfizer in a patent infringement case relating to Lyrica (pregabalin). The court upheld Pfizer’s composition of matter patent and pain and seizure use patents covering Lyrica and ruled the patents were valid through 2018. Lyrica had U.S. sales of $3.7 billion in 2011. Litigation on the same patents remains pending against other generic companies, but no trials have been scheduled in these later cases. (Globes 7/23/12, DrugStoreNews 7/24/12)
Mylan and Somaxon settle suit over Silenor
Mylan has settled a patent litigation suit filed by Somaxon concerning Silenor. Mylan stated that under the settlement, it would have the right to sell doxepin hydrochloride tablets, a generic version of Silenor, starting in January 2020. Mylan will have the right to sell an authorized generic of Silenor for 180 days under a license from Somaxon, a period that may be extended for up to 360 days, after which Mylan can sell its version of the drug under its own regulatory approval application. (DrugStoreNews 7/19/12, Mylan Press Release 7/19/12)
INDUSTRY UPDATES
FDA announces crack down on unapproved Oxycodone
Companies manufacturing and distributing unapproved oxycodone products have 45 days to stop producing the pain medications and 90 days to cease shipping them or risk increased FDA enforcement. The agency warning, published in the July 6 Federal Register, covers oral forms of unapproved single-ingredient, immediate-release oxycodone products. Failure to comply could result in seizure, injunction or other judicial or administrative proceedings, the agency announced. (FDA News 7/11/12)
Sanofi Pasteur begins shipping Fluzone®
Sanofi Pasteur announced that the first lots of Fluzone vaccine began shipping to U.S. health care providers following FDA licensure of the 2012-2013 formulation. This initial shipment represents the first of more than 60 million doses of seasonal influenza vaccine the company plans to deliver to health care providers in the U.S. this influenza season. (Sanofi Pasteur Press Release 7/17/12)
Walgreens and Express Scripts end dispute
Walgreens and Express Scripts ended their nearly year-long dispute with a multiyear pharmacy network agreement that includes rates and terms under which Walgreens will participate in what the companies are calling the broadest Express Scripts retail pharmacy network available. It will include 64,000 pharmacies nationwide as of September 15. "As I've said, we are in the business of providing a broad range of pharmacy, health and wellness services to help meet the needs of all of our customers,” Walgreens president and CEO Greg Wasson said. “I am pleased that Walgreens and Express Scripts have been able to reach an agreement that works for both parties and is consistent with our company’s principles." The companies are not disclosing the terms of the new contract. (DrugStoreNews 7/19/12)
July 27, 2012
Lawsuit Press Release
The Florida Pharmacy Association has filed a lawsuit against AHCA (Agency of HealthCare Administration.)
Industry News - July 10, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Actoplus MET: Launch expected 12/14/12 with co-exclusivity.
Actos: Launch expected 8/17/12 by multiple suppliers including Watson, Ranbaxy, Mylan, and Teva.
Diovan/Diovan HCT: Launch expected 9/21/12, with coexclusivity.
Singulair: All formulations are expected to launch 8/3/12 by multiple suppliers including Dr. Reddy’s, Mylan, Teva, Endo, and Sandoz.
Xopenex: Launch expected 8/20/12 by Watson.
RECENT LAUNCHES
Teva launches generic Symbyax
Teva has launched olanzapine and fluoxetine capsules, a generic version of Eli Lilly’s Symbyax. The branded product had annual U.S. sales of approximately $82 million, according to on IMS sales data. (DrugStoreNews 6/22/12)
FDA approves Perrigo’s generic Duac
Perrigo announced the approval of clindamycin phosphate and benzoyl peroxide topical gel, a generic version of GlaxoSmithKline’s Duac. Perrigo's 2009 regulatory application for the drug included a paragraph IV certification, a legal assertion that the branded drug's patent protection is invalid, unenforceable or won't be infringed. The approval entitles Perrigo to 180 days of market exclusivity in which to directly compete with the branded version. (DrugStoreNews 6/28/12)
Virtus launches generic equivalent of Clarinex
Virtus Pharmaceuticals commenced shipping desloratadine tablets, the AB-rated generic version of Merck’s Clarinex. U.S. annual brand sales were approximately $300 million. Clarinex is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older.(Press Release 7/3/12)
PRODUCT UPDATES
FDA approves generic Lyrica
The FDA has approved Lupin’s pregabalin, a generic version of Pfizer’s Lyrica. A spokesman for Lupin stated it has not yet launched its version of Lyrica, whose U.S. patents expire between October 2013 and the end of 2018, according to the FDA’s Orange Book. Lyrica had sales of approximately $1.8 billion during the 12-month period that ended in March, according to IMS Health. (DrugStoreNews 7/5/12, FirstWord 7/5/12)
Lilly gains pediatric exclusivity for Cymbalta
Eli Lilly announced that it has met FDA requirements for pediatric exclusivity for Cymbalta. Based on this decision by the FDA, Lilly has gained an additional six months of U.S. market exclusivity for Cymbalta (duloxetine hydrochloride), which now will expire in December 2013. Lilly noted, however, that the approval of pediatric exclusivity does not mean that Cymbalta is approved for use in pediatric patients. Cymbalta is only approved for use in adults ages 18 years and older. Based on study results, Lilly will not be seeking a pediatric indication for Cymbalta. (DrugStoreNews 7/5/12)
FDA approves Lupin’s generic Ortho Tri-Cyclen Lo
Lupin announced the approval of norgestimate and ethinyl estradiol tablet, a generic version of Johnson & Johnson’s Ortho Tri-Cyclen Lo. The branded version of the drug had sales of approximately $421 million during the 12-month period that ended in March, according to IMS Health. (DrugStoreNews 7/3/12)
Teva wins patent infringement case over Copaxone
A U.S. district court ruled that patents on Teva's Copaxone (glatiramer acetate) are valid and enforceable, and that the FDA applications that were submitted by Sandoz and Momenta Pharmaceuticals "infringe all of the asserted claims." Teva stated that the court decision covers several patents for the drug, the last of which deals with the manufacturing process and expires on September 2015. (FirstWord 6/25/12)
Mylan confirms patent challenge of Pristiq
Mylan confirmed that the company has been sued by Pfizer in connection with the filing of an ANDA with the FDA for Desvenlafaxine Succinate Extended-release Tablets, the generic version of Pfizer's Pristiq. Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for both strengths and expects to share 180 days of marketing exclusivity upon final FDA approval. For the 12 months ending March 31, 2012, Pristiq had total sales of approximately $559.4 million, according to IMS Health. (PharmaLive 6/28/12)
Watson seeks FDA approval of generic Pristiq
Watson announced it has filed an ANDA with the FDA to market a generic version of Pfizer’s Pristiq. Watson stated Pfizer filed suit against the company concerning its patents on Pristiq, which could result in a stay of final FDA approval until August 2015. Watson said it believes it may be a "first applicant" to file an ANDA for Pristiq and may be entitled to 180 days of market exclusivity, if the application is approved. (Dow Jones Newswires 6/25/12)
INDUSTRY UPDATES
U.S. Supreme Court upholds healthcare law
The US Supreme Court voted 5-4 in favor of a requirement in President Obama's healthcare law for all individuals to hold health insurance by 2014 or pay a fine. However, the court ruled that Congress cannot regulate interstate commerce to require people to buy insurance. The Supreme Court also modified one key provision of the measure, ruling that states may decide not to participate in a broad expansion of Medicaid eligibility without losing their existing funding for the program. While the individual insurance mandate will not be implemented until 2014, many other provisions of the health care law already have gone into effect, including allowing children up to age 26 to remain on their parents' health insurance policies. Starting in 18 months, the court ruling allows those on Medicare to obtain free mammograms; and prevents insurance companies from denying coverage to patients, even those with pre-existing conditions, among other changes. (FirstWord 6/29/12)
FDA orders unapproved oxycodone drugs off market
The FDA is asking companies to stop manufacturing and distributing unapproved drugs containing the oxycodone. The FDA stated it issued the Federal Register notice as part of the Unapproved Drugs Initiative, a program started in June 2006 to remove drugs from the market that have largely avoided regulatory scrutiny generally because their availability predates the agency's current regulatory standards. All the drugs in the current notice are single-ingredient, immediate-release products with oxycodone. (DrugStoreNews 7/6/12)
Industry News - June 20, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Actos: Launch expected mid-August by multiple suppliers.
Cipro OS: Launch delayed until late August.
Clarinex: Potential launch in July by multiple suppliers.
Diovan: Launch expected late September.
Lescol XR: Potential launch still expected until August or September, with co-exclusivity and Sandoz as the authorized generic.
Lidoderm: Launch delayed until January due to a settlement agreement.
Singulair: Launch expected the end of August.
Ziagan: Launch expected June 18th.
PRODUCT UPDATES
Mylan settles Provigil suit with Teva
Mylan has settled all disputes with Teva stemming from litigation brought by Mylan against the FDA, concerning Mylan's ANDA for Modafinil Tablets, the generic version of Cephalon's Provigil. Mylan stated that pursuant to the terms of the agreement with Teva, it is allowed to launch its Modafinil Tablets on August 10, 2012, which is prior to the expiration of the 180-day marketing exclusivity period granted to Teva. Provigil sales totaled $1.2 billion in the United States for the year that ended in March, Mylan stated, citing figures from IMS Health. (rttnews.com 6/8/12)
Sandoz recalls some Introvale birth control pills Sandoz is voluntarily recalling 10 lots of Introvale birth control pills after a consumer recently reported a packaging flaw. Sandoz stated that it decided on the recall after a consumer reported that white placebo tablets were mistakenly placed in the wrong row of a 13-row card. "While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded," Sandoz said, noting it is not aware of any adverse events stemming from the flaw.
The lot numbers involved in the recall are: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the United States between January 2011 and May 2012, Sandoz said.
If a patient finds a white placebo tablet in any position other than the 13th and final row, for the 13th week, she should immediately start using a non-hormonal form of contraception, according to a notice sent out on Wednesday by the U.S. Food and Drug Administration. (Reuters 6/8/12)
Merck loses patent suit against Apotex for generic Nasonex Merck announced that a U.S. district court ruled against the company in a patent infringement lawsuit against Apotex regarding Nasonex (mometasone). In the ruling, the judge stated that Merck's Schering unit had "failed to present credible evidence" of infringement, but also denied Apotex's claim that the patent was invalid. Apotex is seeking FDA approval to sell a generic version of Nasonex, whose patent Merck claims is scheduled to expire in April 2018. Merck filed the lawsuit in 2009 seeking to prevent Apotex from marketing a generic version of the drug prior to patent expiration. However, according to court documents, Apotex claimed that its proposed product has a different active ingredient to that found in Nasonex. Global sales of Nasonex reached $1.2 billion in 2010. (FirstWord 6/18/12)
INDUSTRY UPDATES
Walgreen to Acquire 45% Alliance Boots Stake For $6.7 Billion
Walgreen announced it will pay $6.7 billion for a 45 percent stake in the U.K.’s Alliance Boots as part of a deal that may see it gain full control within three years. Walgreen, will pay $4 billion cash and the remainder in stock, according to a statement issued today. The company will have an option to buy the remaining 55 percent in about three years. (Bloomberg 6/19/12)
Industry News - June 5, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Lescol XR: Potential launch still expected, with co-exclusivity and Sandoz as the authorized generic.
Ziagan: Launch expected June 18th.
RECENT LAUNCHES
Generic versions of Plavix launched
The FDA announced the approval of the 75mg and 300mg formulations of clopidogrel bisulfate, the generic version of Sanofi’s Plavix. Apotex, Aurobindo, Mylan, Roxane, Sun, Teva and Torrent all received approval to market the 75mg formulation, while Teva, Mylan and Gate will make the 300mg formulation. Dr. Reddy's also received FDA approval for the 75mg and 300mg strengths, including exclusivity for the latter. Plavix had sales of $6.74 billion during the 12 month period that ended in March, according to IMS Health. (Drug Store News 5/17/12)
Generic versions of Viramune launched
The FDA announced the approval of the 200mg tablets and 50mg/5mL oral suspension of nevirapine, the generic version of Boehringer Ingelheim’s Viramune. Apotex, Aurobindo, and Mylan all received approval to market their generic versions, while Dr. Reddy’s will market the authorized generic. Viramune had annual U.S. brand sales of approximately $117 million for the 12 month period that ended in March, according to IMS Health. (Press Trust of India 5/23/12, Apotex Press Release 5/23/12, DrugStoreNews 5/23/12)
Actavis launches generic Requip XL
Actavis announced the FDA approval and launch of ropinirole extended-release tablets, the generic version of GlaxoSmithKline's Requip XL. The branded product had sales of approximately $59.4 million in 2011, according to IMS Health. (Drug Store News 5/21/12)
Dr. Reddy’s launches generic Prevacid 24 HR
Dr. Reddy’s Laboratories announced that it has launched over-the-counter (OTC) Lansoprazole delayed-release capsules following FDA approval. Dr. Reddy’s will market the product under store brand labels in the U.S. market. The product is the bioequivalent version of Novartis Consumer Health’s Prevacid 24 HR capsule which received Rx-to-OTC switch approval with 3 years of exclusivity from the FDA on March 18, 2009. (Dr. Reddy’s Press Release 5/21/12)
PRODUCT UPDATES
FDA approves generic Gynazole-1
Perrigo announced the FDA approval of butoconazole nitrate 2% vaginal cream, a generic version of KV Pharmaceutical's Gynazole-1. KV voluntarily discontinued selling the drug in January 2009 due to manufacturing problems. Perrigo stated it was the first company to file a complete regulatory application for the drug with the FDA, thus entitling it to 180 days of market exclusivity. Perrigo will launch the drug at the end of the year under collaboration with KV. (DrugStoreNews 5/24/12)
Watson and Endo settle Lidoderm litigation
Watson announced that it entered into an agreement with Endo to settle all outstanding patent litigation related to Watson's generic version of Lidoderm. The agreement allows Watson to launch its lidocaine topical patch 5% product on September 15, 2013, if approved by the FDA, or earlier under certain circumstances. Watson will have an exclusive license until another company introduces its own generic or seven and one half months after Watson's generic launch. Endo will receive 25% of the gross profit generated on Watson's sales of its generic version of Lidoderm during Watson's period of exclusivity. The agreement also calls for Endo to provide progressively larger amounts of branded Lidoderm the longer it takes the FDA to approve Watson’s application. (Endo Press Release 5/30/12, Dow Jones Newswire 5/30/12)
Perrigo announces FDA approval generic Delsym
Perrigo announced that the FDA has granted final approval to Tris Pharma for its ANDA for Dextromethorphan Polistirex Extended-Release Oral Suspension, the store brand equivalent to Reckitt Benckiser's Delsym suspension. As the exclusive marketer and distributor of this product for the store brand over-the-counter market, Perrigo expects to begin shipping its product during its first fiscal quarter of 2013. (PharmaLive 5/30/12)
INDUSTRY UPDATES
More than a third of prescriptions now electronic
According to new statistics, more than a third of the nation's prescriptions are now electronic. The government has been pushing doctors to e-prescribe, partly due to patient safety concerns. This year, holdouts will start to see cuts in their Medicare payments. A recent report from Surescripts, the largest network for paperless prescribing, shows more doctors are signing up. At the end of 2011, 36 per cent of all prescriptions were electronic, an increase from 22 per cent a year earlier. New research by Surescripts and some pharmacies and pharmacy benefit managers revealed that more patients pick up a new prescription when it's filed electronically. The new research examined 40 million prescriptions, a mix of paper, phoned, faxed or electronic ones — and found a 10 per cent increase in patients who fill a prescription when it's e-prescribed. (Associated Press 5/17/12)
Industry News - May 17, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Fortamet: Watson may launch as the Authorized Generic.
Lescol XR: Potential launch still expected, with co-exclusivity and Sandoz as the authorized generic.
Lidoderm Patches: Potential launch by Watson or Mylan in early July. However, there may be bioequivalency issues with Watson’s product due to Endo’s Citizen’s Petition.
Lovaza: Potential at risk launch in May.
Plavix: Launch expected to be on 5/17/12. Dr. Reddy’s is expected to be exclusive on the 300mg, with multiple suppliers launching the 75mg.
Viramune: Launch expected by multiple suppliers on 5/22 for tablets and oral solution.
Ziagan: Launch expected June 18th.
RECENT LAUNCHES
Mylan launches generic Doryx
Mylan has launched doxycycline hyclate delayed-release (DR) tablets, the generic version of Mayne Pharma's Doryx. Doryx is indicated for the treatment or prevention of infections that are proven or strongly suspected to be caused by susceptible bacteria, including those that cause acne. Doxycycline hyclate DR tablets had U.S. sales of approximately $264 million for 2011, according to IMS Health. (DrugStoreNews 5/1/12)
INDUSTRY UPDATES
Novartis to buy Fougera for $1.5 billion
Novartis AG announced it will spend $1.5 billion for Fougera Pharmaceuticals, in a deal to become the top seller of generic skin medications. Fougera had sales of about $429 million in 2011 and is owned by private equity funds. The all-cash acquisition will make Sandoz, the generic drug unit of Novartis, the global leader in generic dermatology medicines with estimated revenue of $620 million, the companies stated. (Bloomberg 5/3/12)
US court upholds patent on Abilify
Otsuka announced that the U.S. Court of Appeals for the Federal Circuit ruled in favor of the company and partner Bristol-Myers Squibb in litigation concerning generic versions of Abilify (aripiprazole). Otsuka noted that the court affirmed that a patent covering the active ingredient in Abilify is valid, maintaining U.S. patent protection until at least April 20, 2015. The patent had been challenged by Teva and Apotex. (FirstWord 5/9/12)
Watson seeks approval for generic Lialda
Watson announced that it had filed an ANDA with the FDA for melamine delayed-release tablets, a generic version of Shire’s Lialda. Watson's filing included a Paragraph IV certification, a legal assertion that Lialda's patent protection is invalid, unenforceable or won't be infringed. In response, Shire and two other companies filed suit against Watson seeking to prevent Watson from commercializing its drug, alleging that it infringes a patent that expires in June 2020, according to the FDA. Under laws governing generic drugs, the lawsuit puts a stay of final FDA approval on Watson's drug for up to 30 months or until the companies settle. Lialda had sales of approximately $390 million during the 12-month period that ended in March, according to IMS Health. (DrugStoreNews 5/10/12)
May 15, 2012
Outcomes Announces Provider-Focused Webinar Series
Participants will discuss Outcomes Medication Therapy Management opportunities.
May 8, 2012
Improve Quality Reduce Legal Risk - Free Seminar
Join the Alliance for Patient Medication Safety (APMS) for a FREE seminar on May 16th! During the seminar you will learn why you should be working with a Patient Safety Organization (PSO).
May 2, 2012
Community Florida Pharmacy Re-Permitting
Effective July 1, 2012, a community pharmacy must be re-permitted by the Florida Board of Pharmacy in order to dispense C II's & C III's, as provided in section 893.03, Florida Statutes. Click here to read more
April 26, 2012
Outcomes CMR Video #5
Outcomes, a preferred vendor of PPSC, has filmed an educational series of Comprehensive Medication Review (CMR) videos. This is the final video in the series.
April 20, 2012
Outcomes CMR Video #4
Outcomes, a preferred vendor of PPSC, has filmed an educational series of Comprehensive Medication Review (CMR) videos. Check back next week for the final video.
April 16, 2012
Outcomes CMR Video #3
Outcomes, a preferred vendor of PPSC, has filmed an educational series of Comprehensive Medication Review (CMR) videos. We will continue to post this series over the next few days.
Industry News - April 12, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Fosrenol: Potential launch early May by Perrigo, Patriot
Lescol XR: Potential launch 4/12/12, with co-exclusivity and Sandoz as the authorized generic.
Plavix: Potnetial launch 5/17/12. Dr. Reddy's is expected to be exclusive on the 300mg, with multiple suppliers launching the 75mg
Prandamet: Was originally expected to launch 3/24/12, but now is delayed.
Revatio: Received pediatric extension and will no longer be launching on 3/27/12. Potential launch late September.
Viramune: Potential launch early May. Lupin is expected to have 180 days of exclusivity due to a settlement agreement.
RECENT LAUNCHES
Apotex launches generic Boniva
Apotex received final FDA approval and has launched Ibandronate Sodium 150mg Tablets, a generic version of Roche's Boniva. Apotex, Mylan and Orchid all received FDA For the twelve months that ended December 31, 2011, Boniva had total U.S. sales of approximately $516,769,000, according to IMS Health data. (Apotex Press Release 3/20/12)
FDA approves Watson's generic version of Boniva
The FDA has approved Watson's ibandronate 150mg tablets, a generic version of Genentech's Boniva. Watson plans to launch its version in second quarter 2012 Boniva had sales of $510 million during the 12-month period ended in January, according to IMS Health. (DrugStoreNews 3/21/12)
Glenmark launches generic Cutivate
Based on a settlement agreement, Glenmark began shipping their AB-rated generic equivalent of Nycomed's Cutivate (fluticasone propionate) Lotion on March 26 The brand is currently sold in a 120mL size, while Glenmark has launched a 60mL tube Glenmark will be wholly exclusive for 180 days, with no authorized generic Annual U.S. brand sales were approximately $48 million for 2010, according to IPD. Cutivate lotion is indicated for the relief of the inflammatory and pruritic manifestations of atopic dermatitis in patients one year of age or older. (Press Release 3/26/12)
Generic versions of Seroquel launched
Three drug manufacturers have launched generic versions of AstraZeneca's Seroquel following a court decision turning down the brand company's request for an injunction against the FDA Dr. Reddy's, Teva and Mylan announced the launch of their respective versions of quetiapine fumarate tablets, generic formulations of AstraZeneca's Seroquel, in strengths ranging from 25 mg to 400 mg Lupin and Sun also announced they had received FDA approval Seroquel is used to treat schizophrenia, bipolar disorder and depression. The branded product had sales of $4.6 billion in 2011, according to IMS Health. (DrugStoreNews 3/28/12, DowJones 3/29/12)
Teva launches authorized generic of Provigil
Teva announced the launch of the authorized generic of Cephalon's Provigil (modafinil) Shipping of the product has commenced The brand product had annual U.S. sales of approximately $1.1 billion, based upon IMS data. (Teva Press Release 4/2/12)
Teva launches generic versions of Sanofi's Avapro and Avalide
Teva announced that it has launched generic versions of Sanofi's Avapro (irbesartan) and Avalide (irbesartan/hydrochlorothiazide) in the US. Teva also noted that it has 180 days of marketing exclusivity for the two hypertension products, which generated annual sales of $464 million and $124 million, respectively, in the US. (FirstWord 4/2/12)
Caraco launches Stalevo
Caraco launched the authorized generic Stalevo (carbidopa, levodopa and entacapone) in the 100mg and 150mg strengths, under the terms of a settlement agreement with Orion Additional strengths are anticipated to launch in late April from Wockhardt Stalevo is indicated to treat patients with idiopathic Parkinson's disease The two strengths that are launching had annual U.S. brand sales of approximately $204 million. (Press Release 4/5/12)
FDA launches generic Vancocin
The FDA approved both Watson's and Akorn's vancomycin hydrochloride capsules in the 125-mg and 250-mg strengths, generic versions of ViroPharma's Vancocin In addition, Prasco announced that it had signed a deal with ViroPharma to market an authorized generic version of Vancocin Vancomycin hydrochloride is used to treat diarrhea associated with Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains Vancocin had sales of $332 million during the 12-month period that ended in February, according to IMS Health. (DrugStoreNews 4/10/12, PharmaLive 4/10/12, DrugStoreNews 4/12/12)
INDUSTRY UPDATES
Abbott sues Watson over Niaspan
Abbott has sued Watson for allegedly infringing two patents for Niaspan Abbott contends that Watson is planning to market a generic version of Niaspan prior to patent expiration, according to a complaint filed March 16 Watson's effort to sell the generic tablets "has led to foreseeable harm and injury to Abbott," according to the lawsuit, which seeks a ruling of infringement and an order to stop Watson's premature sale of the drug Niaspan had U.S. sales of approximately $1.2 billion in the 12 months that ended January 31, according to Watson in a statement citing IMS Health data Watson confirmed in the statement that it has filed an application with the FDA for approval to sell its version of the extended-release tablets. (Bloomberg News 3/19/12)
Watson said to be in close to buying Actavis
Watson is nearing an agreement to purchase Actavis, creating one of the world's largest producers of generic drugs, according to people familiar with the process Watson may pay approximately 4.5 billion euros ($6 billion) for Actavis, two of the people said, declining to be identified because the talks are private. Proceeds from a sale would allow Deutsche Bank to recover money it loaned to Icelandic billionaire Bjorgolfur Thor Bjorgolfsson to acquire the company in 2007. Actavis refinanced its debt in 2010 and Deutsche Bank posted an impairment of 407 million euros related to the manufacturer last year Mylan also approached Actavis, but hasn't made a formal bid, a person familiar with the situation said. The complexity of Actavis's businesses, which were cobbled together through a series of acquisitions, has been holding back other companies from making competing bids, the person said. (Bloomberg 3/29/12)
Bausch + Lomb to acquire ISTA Pharmaceuticals
Bausch + Lomb and ISTA Pharmaceuticals announced that they have signed a definitive agreement under which Bausch + Lomb will acquire ISTA for approximately $500 million. The transaction, which has been unanimously approved by the boards of directors of both companies, is expected to close in the second quarter of 2012 Bausch + Lomb's acquisition of ISTA accelerates the company's strategy to strengthen its pipeline and marketed products and capabilities. The transaction is expected to drive growth and high performance for the long term "ISTA is an excellent strategic fit with Bausch + Lomb's rapidly growing pharmaceutical business, and this combination represents an important step in Bausch + Lomb's commitment to becoming the best global eye health company," said Brent Saunders, president and chief executive officer, Bausch + Lomb. "Because Bausch + Lomb already manufactures nearly all of ISTA's current U.S. products, our companies have known each other well for many years. "The transaction, which is expected to be accretive to Bausch + Lomb's EBITDA in the first year after close, is subject to regulatory approval and other customary closing conditions, including the approval of ISTA's shareholders. The companies will continue to operate independently until completion of the transaction. (Marketwire 3/26/12)
Mylan sues FDA to overturn Teva exclusivity for Provigil
Mylan sued the FDA to overturn a decision that gives Teva 180days of exclusivity to market a generic version of Provigil Mylan applied for FDA approval of its generic version of Provigil and planned to start marketing it on April 6, 2012 Teva acquired the rights to Provigil through its acquisition of Cephalon. Provigil, used to improve daytime wakefulness in people suffering from narcolepsy and sleep apnea, had U.S. sales of approximately $1.1 billion last year, according to a Mylan statement, citing data from IMS Health. The FDA's decision prevents other companies from introducing generic versions of the drug. Mylan stated in its complaint that Teva can't be granted exclusivity because it didn't maintain valid paragraph IV certifications when it purchased Cephalon. Federal law encourages generic-drug companies to challenge patents held by a branded-drug company, Mylan said. "Upon acquiring such control of Cephalon, Teva no longer had standing to challenge the validity, unenforceability or infringement of patents that it indirectly owns," Mylan said in the lawsuit. (Bloomberg 4/5/12)
Express Scripts completes acquisition of Medco
Express Scripts announced that it completed its $29.1 billion acquisition of Medco Health Solutions, creating the largest pharmacy benefits manager (PBM) in the country The closing came after the Federal Trade Commission voted to close its investigation into the deal, clearing the last hurdle in its path. The deal creates a PBM so large that it will handle the prescriptions of approximately 135 million people, or more than one in three Americans Both companies touted the savings and efficiency that the combination would create, while others in the industry have voiced concerns about competition An alliance of drugstores and community pharmacists filed a federal lawsuit to prevent the deal from going through, saying it would create a giant PBM with too much leverage and market share Express Scripts Chairman and CEO George Paz stated the combination of the two companies will both lower costs and improve patient care. (The Canadian Press 4/2/12)
April 11, 2012
Outcomes CMR Video #2
Outcomes, a preferred vendor of PPSC, has filmed an educational series of Comprehensive Medication Review (CMR) videos. We will continue to post these videos over the next few days.
April 10, 2012
Governor Signs Florida's Vaccine Access Act
Effective July 1, 2012 Florida pharmacists will be qualified and certified to administer vaccines for pneumonia & Zostavax for shingles.
April 6, 2012
Outcomes CMR Video #1
Outcomes, a preferred vendor of PPSC, has filmed an educational series of Comprehensive Medication Review (CMR) videos. We will continue to post this series over the next few weeks.
April 4, 2012
NCPA Sues PBM's
NCPA, NACDS, and nine other pharmacy companies, recently filed a lawsuit in federal court to stop the ESI-Medco merger.
March 28, 2012
Fillmaster Plus Video
Check out this great video from one of PPSC's preferred vendors, FLAVORx. Keep your pharmacy thriving by purchasing FLAVORx products. Visit their ad on page 27 in the interactive Buyers Guide.
Industry News - March 19, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
UPCOMING POTENTIAL LAUNCHES
Avalide: Many potential suppliers expected to launch on 3/30/12, including Teva, Ranbaxy, and Prasco.
Avandia: Was expected to launch 3/12/12, but probably will not due to issues with REMS program.
Avapro: Teva expected to launch exclusively on 3/30/12 with Prasco as the Authorized Generic.
Cutivate: Glenmark expected to launch on 3/25/12.
Prandamet: Was originally expected to launch 3/24/12, but believed now to be delayed.
Provigil: Several suppliers are expected to launch on 4/6/12 including Sandoz, Par, Mylan, and Ranbaxy.
Revatio: Received pediatric extension and will no longer be launching on 3/27/12.
Seroquel: Many suppliers are expected to launch on 3/26/12.
RECENT LAUNCHES
Mylan launches generic Lexapro
Mylan announced the launch of escitalopram tablets, the first generic version of Forest's Lexapro. Lexapro had U.S. sales of approximately $2.9 billion in 2011, according to IMS Health. Mylan stated it would market its version exclusively until Lexapro's period of market exclusivity for use in children expires, according to an agreement between Forest Labs and Mylan's Alphapharm subsidiary. (DrugStoreNews 2/29/12)
Teva launches generic Lexapro
Teva received FDA approval to sell its generic version of Lexapro for depression and anxiety. Teva will have 180 days to exclusively sell its generic, according to the FDA. (Bloomberg 3/15/12)
Amneal Launches generic Lexapro Oral Solution
Amneal announced the launch of Escitalopram Oxalate Oral Solution, a therapeutically equivalent alternative to Lexapro Oral Solution. Annual U.S. sales of Lexapro Oral Solution are $7.3 million according to December 2011 IMS Health market data. (PharmaLive 3/15/12)
Perrigo launches store-brand equivalent to Claritin-D
Perrigo announced that it has begun shipping Loratadine-D 12-hour extended-release tablets, the store brand equivalent to Merck Consumer's Claritin-D 12-hour extended-release tablets. The brand product generates approximately $111 million annually, according to Perrigo citing data provided by Wolters Kluwer. (DrugStoreNews 2/14/12)
Teva launches generic version of Prometrium
Teva launched progesterone capsules, a generic version of Abbott's Prometrium. Prometrium is indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogen tablets. The drug also is indicated for use in secondary amenorrhea. For the 12 months that ended January 31, Prometrium had sales of approximately $198 million, according to IMS Health data. (Teva Press Release 3/1/12, DrugStoreNews 3/2/12)
Watson launches authorized generic of Prometrium
Watson has launched progesterone capsules, an authorized generic drug Abbott's Prometrium.Uunder an agreement with Abbott, Abbott will manufacture the drug and supply it to Watson, which will market and distribute it and share profits. Other terms of the agreement were not disclosed. (DrugStoreNews 3/2/12)
Dr. Reddy's launces generic Geodon
Dr. Reddy's announced that it has launched Ziprasidone Hydrochloride Capsules, a generic version of Pfizer's Geodon. Geodon had U.S. sales of approximately $1.34 billion for the most recent twelve months ending December 2011, according to IMS Health. Greenstone also started shipping the authorized generic of Geodon. (Press Release 3/5/12)
PRODUCT UPDATES
Santarus and Depomed settle with Lupin over Glumetza
Santarus and Depomed announced that they have entered into a settlement agreement with Lupin to resolve pending patent litigation involving Glumetza (extended release metformin tablets) 1000mg and 500mg. The settlement agreement grants Lupin the right to begin selling a generic version of Glumetza on February 1, 2016, or earlier under certain circumstances. Last month, Lupin stated it received tentative FDA approval for its generic version of Glumetza. (Reuters 2/22/12)
Mylan targets 2013 launch of generic Copaxone
Mylan indicated at an investor meeting that that it expects to launch a generic version of Teva's Copaxone in the second half of 2013. The company noted that patent litigation and FDA approval of the product, which garnered sales of nearly $3.6 billion last year, are pending. (FirstWord 2/22/12)
Managed care plans prefer generic over branded Lipitor
Managed care and prescription plans are working to switch patients to generic versions of Pfizer's Lipitor despite the manufacturer's efforts to reduce costs for the branded version, a new study suggested. According to a report released by Wolters Kluwer Pharma Solutions' inThought research group, while Lipitor (atorvastatin) has 41% of the market share of all dispensed prescriptions of atorvastatin, it has 35% of the payer approval volume. The report noted that Pfizer has used several managed care strategies to maintain its brand share of the drug, which lost patent protection in November 2011 and now faces competition from a generic version made by Ranbaxy. But despite Pfizer's efforts to lower patient costs, it has retained less than half the total atorvastatin pill count, 10 weeks after the generic became available. "Since the 35% approval volume is lower than Lipitor's current market share, the claims data suggest that Lipitor volumes will continue to decline," Wolters Kluwer inThought analyst and author of the report Rusty Jones said. "Despite the discounts, managed care plans are still financially motivated to put their patients on generic atorvastatin." (DrugStoreNews 2/15/12)
INDUSTRY UPDATES
Mylan rebrands Dey unit
Mylan announced that it would change the name of Dey Pharma, its branded specialty pharmaceutical business, to Mylan Specialty. Dey makes treatments for respiratory diseases, psychiatric disorders and severe allergic reactions, including the EpiPen (epinephrine). (DrugStoreNews 2/16/12)
March 7, 2012
Florida Pharmacists Get Shot At More Vaccinations
The Senate approved HB 509 allowing Floridians to visit their neighborhood pharmacies to get vaccinations for pneumonia and shingles.
February 24, 2012
Outcomes Announces Medicare-Focused Webinars
Participants to discuss 2013 MTM compliance, opportunities.
February 17, 2012
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The Winner Is...
February 17, 2012
ESI-Medco Merger
David Balto, leading Washington PBM advocate, is opposing the Express-Scripts Medco Merger and needs your support today.
February 17, 2012
PCAN Newsletter
Pharmacy Choice and Access Now (PCAN) Newsletter
Industry News - February 15, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
RECENT LAUNCHES
Apotex launches generic Zanaflex Capsules
Apotex received final FDA approval for their AB-rated generic to Acorda Therapeutics Zanaflex (tizanidinehydrochloride) capsules. Annual brand sales are approximately $45M,according to IMS. Watson may enter themarket as an authorized generic. (Press Release 2/9/12)
PRODUCT UPDATES
Perrigo files ANDA for generic Astepro Nasal Spray
Perrigo announced that it filed an ANDA with the FDA forazelastine hydrochloride nasal spray (0.15%), a generic version of Meda's Astepro. On January 19, 2012, Meda filed suit against Perrigo, alleging patentinfringement and formally initiating the process under the Hatch-WaxmanAct. Annual sales of Astepro were approximately $114 million annually, asmeasured by Wolters Kluwer Health. (Perrigo Press Release 1/23/12)
Watson seeks FDA approval for generic Beyaz
Watson has filed an ANDA with the FDA for its genericversion of Bayer's Beyaz oral contraceptive. Bayer and Merck filed a lawsuitagainst Watson to prevent Watson from launching a generic version of Beyazprior to the expiration of its patent. Watson stated it believes it may be a"first applicant" to file an ANDA for a generic version of Beyaz andmay be entitled to 180 days of market exclusivity, if the application isapproved. (Wall Street Journal 2/10/12)
Mylan to challenge court decision over generic Xopenex
Mylan plans to challenge a court decisionthat requires it to pay almost $20 million to Sunovion, whose product it triedto market as a generic. Sunovion suedMylan when Mylan sought to market a generic version of Sunovion's Xopenex(levalbuterol hydrochloride) inhalation solution. The jury's verdict includesan $18 million award. "While thisis not a significant product for Mylan, we firmly believe that the jury haserred and intend to seek reversal through post-trial motions and, if necessary,an appeal of the verdict and the damages award," Mylan CEO Heather Breschsaid. (Drugstore News 2/15/12)
Watson and J&J settle lawsuitover generic Ortho Tri-Cyclen Lo
Subsidiaries of Watson and Johnson &Johnson have settled a lawsuit filed by J&J in 2008 when Watson attemptedto market a generic version of Ortho Tri-Cyclen Lo (norgestimate and ethinylestradiol). Janssen filed the suit after Watson sought FDA approval for thedrug prior to the expiration of a patent covering it. The patent covering thedrug's use in adults is scheduled to expire in June 2019, according to FDArecords. Under the settlement, Janssenwill manufacture and supply Watson with an authorized generic version of thedrug, while Watson will have the right to market and distribute it at the endof 2015. Other terms of the deal were not disclosed. (Drugstore News 2/8/12)
Watson and Mallinckrodt settle over generic Exalgo
Watson and Mallinckrodt have reached asettlement concerning Exalgo, for which Watson had sought FDA approval. Mallinckrodt filed a patent-infringement suitagainst Watson in December 2010 after Watson applied for FDA approval for ageneric version of the drug in the 8mg, 12mg and 1-mg strengths. Under the settlement, Watson receives aroyalty-free license to patents related to Exalgo and can launch a genericversion in November 2013. Other terms of the settlement were not disclosed.Watson stated it was probably the first company to seek approval for a genericversion, which would entitle it to 180 days of market exclusivity. (DrugStoreNews1/30/12)
Lupin receives tentative FDA approval for generic Glumetza ER
Lupin announced it received tentative FDA approval for its metforminhydrochloride extended release tablets, the AB-rated generic version ofSantarus’ Glumetza ER. The brand hadannual U.S. sales of approximately $58 million, for the twelve months endingSeptember 2011, according to IMS Health Data. Lupin believes it is the first applicant to file an ANDA for a genericversion of Glumetza ER and will be entitled to 180 days of marketingexclusivity. (PharmaBiz 1/30/12)
FDA approves Mylan's generic Doryx
The FDA approved Mylan's doxycycline hyalitedelayed-release tablets, a generic version of Warner Chilcott's Doryx. Warner Chilcott launched a patentinfringement suit against Mylan in response to the latter's filing for FDAapproval of the drug. The court is expected to reach a decision in March, andMylan stated it agreed not to launch the drug until then, though it expected tobe the first to launch a generic version. Doryx had sales of approximately $264.1 million in 2011, according toIMS Health. (Drugstore News 2/9/12)
February 14, 2012
FPA Stat News
Read a copy of FPA's Stat News
February 14, 2012
SB 1602
Attachment: SB_1602.pdf
Industry News - January 20, 2011
By: Kristen N. Reabe, Pharm.D
Industry News
POTENTIAL UPCOMING GENERIC LAUNCHES
ClarinexReditab: Launch expected early January bymultiple suppliers, including Dr. Reddy’s and Greenstone as the authorizedgeneric.
Gastrocrom: Launch could occur anytime byPerrigo with Prasco as the authorized generic.
Prometrium: Potential launch may occur inearly January by Teva.
ZanaflexCapsule: Launch may occur sometime infourth quarter.
PRODUCT UPDATES
Mylan confirms patent challenge to Actoplus Met XR
Mylan confirmedthat it has been sued by Takeda, Watson and Andrx in connection with the filingof an ANDA with the FDA for Pioglitazone Hydrochloride and Extended-releaseMetformin Hydrochloride tablets, 15mg/1000mg and 30mg/1000mg, the genericversion of Actoplus Met XR. Mylanbelieves it is the first company to have filed a substantially complete ANDAcontaining a Paragraph IV certification for all strengths and expects toqualify for 180 days of marketing exclusivity upon final FDA approval. For the12 months that ended September 30, 2011, Actoplus Met XR had U.S. sales ofapproximately $13.9 million for the 15mg/1000mg product and $7.5 million forthe 30mg/1000mg product, according to IMS Health. (PR Newswire 1/9/12)
FDAwarns of pill mix-up
TheFDA is warning patients about a potential mix-up between prescription paindrugs and common OTC medications made at a Novartis manufacturing plant. Theissue stems from manufacturing problems at a Lincoln, Nebraska facility whichtriggered a recall of 1,645 lots of Novartis' OTC drugs, including Excedrin,Bufferin, NoDoz and Gas-X. Novartis has received hundreds of complaints ofbroken and chipped pills and inconsistent bottle packaging that could causepills to be mixed up. Consumers are advised to stop using the products andcontact the company for a refund. FDA officials warned that some of Novartis' OTCpills may have accidentally been packaged with prescription painkillers made atthe same facility. The opioid products are sold by Endo as Percocet, Endocet,Opana and Zydone. Endo stated it is not aware of any confirmed product mix-upsthat reached patients or caused any injuries. The FDA and Endo recommend patients examine theirprescriptions to make sure all the tablets are similar in shape, color, sizeand marking. If one or more of the tablets look different, patients shouldreturn the medicine to their pharmacist.FDA officials say they are not recalling thepainkillers as they are essential medications for many patients and the risksof stray pills are low. (Associated Press 1/9/12)
Endo addresses possible short-term supply constraint of OpanaER
Endo announced a short-term supply constraint ofanalgesic products, including Opana ER, due to the temporary shutdown of amanufacturing facility operated by Novartis Consumer Health. "We areworking collaboratively with the [Food and Drug Administration] to minimize thedisruption to patients currently on therapy. Given existing inventories, theexpected restart of Novartis production and our ability to shift production toother facilities we believe the supply constraints of our products should belimited," Endo COO Julie McHugh said. "With Novartis as the solemanufacturer of the current formulation of Opana ER, we plan to temporarilymoderate demand of the product by asking physicians torefrain from starting new patients on Opana ER in order to minimize disruptionfor patients currently on the product. (DrugStoreNews1/10/12)
Lipitor sales level off after genericlaunch
Sales of Lipitor have leveled off after a steep plunge followingthe start of U.S. generic competition. New figures from IMS Health show that atthe end of December, sales of Pfizer's Lipitor were at just above a 37 percentmarket share. Two new generic versions werelaunched at the beginning of December, and in the first full week of the monththey had a combined share of 59 percent of sales. By the last week of December,atorvastatin from Ranbaxy and the authorized generic from Watson only gainedanother 4 percent between them. (Associated Press 1/13/12)
January 18, 2011
Re-Permitting for Florida Community Pharmacies
Effective July 1, 2012 Florida community pharmacies dispensing Schedule II or Schedule III controlled substances must be re-permitted.
January 18, 2011
Outcomes Announces MTM Provider Fee Increase
Comprehensive Medication Review rate reflects growing focus on key service.
Industry News - January 6, 2012
By: Kristen N. Reabe, Pharm.D
Industry News
POTENTIAL UPCOMING GENERIC LAUNCHES
Clarinex Reditab: Launch expected early January by multiple suppliers, including Dr. Reddy’s and Greenstone as the authorized generic.
Gastrocrom: Launch could occur anytime by Perrigo with Prasco as the authorized generic.
Prometrium: Potential launch may occur in early January by Teva.
Zanaflex Capsule: Launch may occur sometime in fourth quarter.
RECENT LAUNCHES
Teva launches generic Combivir
Teva announced they received final FDA approval for their ANDA for lamivudine and zidovudine tablets, the AB-rated generic version of GlaxoSmithKline’s Combivir. Teva is expected to be the exclusive generic supplier of this product. (Press Release 12/27/11)
Mylan launches generic Teveten
Mylan announced that it received final FDA approval for its ANDA for Eprosartan Mesylate 400mg and 600mg Tablets, the generic version of Abbott’s Teveten. Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification to the FDA for Eprosartan Mesylate and was awarded180 days of marketing exclusivity. Mylan is shipping this product immediately.
(Mylan Press Release 1/2/12)
Rhodes launches authorized generic of Ryzolt
Rhodes received final FDA approval for its ANDA for tramadol hydrochloride extended-release tablets, the authorized generic of Purdue’s Ryzolt. Rhodes has begun shipping this product. Ryzolt is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Ryzolt had annual sales of approximately $4.9 million, according to IMS Health data. (Press Release 1/2/12)
Actavis launches generic Clobex Lotion and Shampoo
Based on a settlement agreement, Actavis commenced shipping of their AB-rated generic version of Clobex (Clobetasol) lotion and shampoo. Annual brand sales are approximately $60M combined for both the shampoo and lotion. Actavis has 180 days of marketing exclusivity, while Sandoz will supply the authorized generic for the lotion and Perrigo will supply the authorized generic for the shampoo. (Press Release 1/3/12)
Actavislaunches generic Ritalin LA
Actavis announced the FDA approval of methylphenidate hydrochloride 20mg, 30mg, and 40mg extended-release capsules, the generic version of Novartis's Ritalin LA. Actavis stated it was the first to file for regulatory approval of the drug in those three strengths,thus entitling it to 180 days of market exclusivity. Ritalin LA had sales of$80.7 million during the 12-month period that ended in September, according to IMS Health. (DrugStoreNews 1/4/12)
PRODUCT UPDATES
Perrigo announces final FDA approval for generic Clarinex
Perrigo announced that it has received final FDA approval for its ANDA for Desloratadine 5mg tablets, the generic version of Schering-Plough’s Clarinex. Perrigo had been sued for patent infringement based upon its filing of an ANDA containing a Paragraph IV certification ands ettled the case in 2008. Under the terms of the settlement, Perrigo can commercially launch its generic Desloratadine on July 1, 2012, or earlier in certain circumstances. The new product launch may be a prescription or over-the-counter product depending on its status at the time of launch. (Perrigo Company Press Release 1/2/12)
Industry News - December 16, 2011
By: PPSC
Industry News
POTENTIAL UPCOMING GENERIC LAUNCHES
Clarinex Reditab: Launch expected early January by multiple suppliers, including Dr. Reddy’s and Greenstone as the authorized generic.
Clobex Lotion/Shampoo: Launch expected in first quarter of 2012.
Combivir: Exclusive launch expected late December by Teva.
Gastrocrom: Launch could occur anytime by Perrigo with Prasco as the authorized generic.
Ryzolt: Product is expected to lose exclusivity at the end of December, so a launch is possible.
Zanaflex Capsule: Launch may occur sometime in fourth quarter.
RECENT LAUNCHES
Watson launches generic LoSEASONIQUE
Watson announced that under a settlement with TevaWomen's Health, Watson has launched Amethia Lo (levonorgestrel/ethinylestradiol (0.1mg/0.02mg) and ethinyl estradiol (0.01mg)) tablets, the generic equivalent of Teva's LoSEASONIQUE. Terms of the settlement were not disclosed. As a "first applicant" to submit a substantially complete ANDA, Watson is eligible for 180 days ofshared generic market exclusivity. LoSEASONIQUE had U.S. sales of approximately $28million for the twelve months ending September 30, 2011, according to IMSHealth. (PharmaLive12/8/11)
Ranbaxy launches generic Lipitor
The FDA announced the approval of Ranbaxy's atorvastatincalcium tablets, the generic version of Pfizer’s Lipitor. Ranbaxy’s U.S. unitOhm Laboratories in New Brunswick, N.J. will manufacture the drug. Ranbaxy had been scheduled to launch earlierin the day on November 30th to coincide with the expiration ofPfizer's patent on Lipitor, but the FDA held off approval until the resolutionof quality-control issues related to two of its manufacturing plants in India.Watson announced the launch of its authorized generic version in themorning. Under federal law, Ranbaxy isentitled to 180 days of market exclusivity in which to compete directly withPfizer. While the FDA is not allowed to give final approval to any other genericversion until the exclusivity period is over, Watson still can market itsauthorized generic as it is the branded version of the drug marketed under itsgeneric name and is thus not subject to regulatory approval. Lipitor had sales of $7.8 billion during the12-month period that ended in September, according to IMS Health. (Drug Store News 12/1/11)
Watsonlaunches generic Lipitor
Watson has launched anauthorized generic version of Lipitor (atorvastatin calcium tablets) as part ofan exclusive agreement with Pfizer. Under the terms of the exclusive supply anddistribution agreement, Pfizer manufactures and supplies Watson with all dosagestrengths of the authorized generic product. Watson markets and distributes theproduct in the United States. Pfizer will receive a share of the net sales fromWatson's sales of the product. The agreement runs until November 30, 2016.Other terms of the agreement have not been disclosed.(FirstWord 11/30/11)
Teva receives tentative FDA approval for generic Lipitor
The FDA hasgranted Teva tentative approval to sell a generic version of Pfizer’s Lipitor. The FDA cannot grant final approval until May31. Ranbaxy has the exclusive right to sell generic Lipitor, or atorvastatin,for 180 days after Lipitor’s patent expired on November 30, because it was thefirst company to successfully challenge Lipitor’s patent. Teva plans to begin selling its generic inlate May, after the exclusivity period ends. Ranbaxy began shipping its version after getting FDA approval. Watson isselling an authorized generic under a partnership with Pfizer.(Associated Press 12/1/11, Reuters 12/2/11)
Apotex launches generic Epivir
On December 2, Apotex received final FDA approval for their AB-rated generic version of GlaxoSmithKline’s Epivir (lamivudine)tablets. Annual U.S brand sales for this drug in 2010 were approximately $75 million. Apotex has begun shipping (Press Release 12/2/11)
Mylan launches generic Caduet
Mylan launched and began shipping amlodipine besylate andatorvastatin calcium tablets, a generic version of Pfizer's Caduet. Caduet tablets had U.S. sales ofapproximately $339 million for the 12 months that ended September 30, accordingto IMS Health. (Drug Store News 12/1/11)
Lupin launches generic Solodyn
Lupin has received final FDA approval for its ANDA to market its Minocycline hydrochloride extended-release tablets, a generic version of Medicis's Solodyn. In July this year, Lupin had settled the litigation over Solodyn with Medicis. At the time, Lupin stated the settlement meant it could start selling the drug in 45mg, 90mg and13 mg strengths under a license from Medicis in November. The settlement also entitles Lupin to start selling Solodyn in other strengths from February 2018and 2019. Solodyn had sales of $ 750million for the year that ended September 2011, Lupin stated citing IMS Healthdata. (Moneycontrol.com 12/2/11)
Watson launches genericKadian
Watson received FDA approval for its ANDA for morphine sulfate extended-release capsules, the generic equivalent of Actavis' Kadian. Kadian is used for management of moderate to severe pain that lasts for an extended period of time. Watson has started shipping the product. According to data by IMS Health, Kadian had sales of approximately $275m in the twelvemonths ending September 30, 2011. (PBR11/11/11)
Amneal launches generic Dermotic andDerma-Smoothe/FS
Amneal announced that the FDA granted final approval for its ANDA for first to market Fluocinolone Acetonide oils, the AT-rated generic versions of Hill Dermaceutical’s DermOtic and Derma-Smoothe/FS. Annual U.S. brand sales are approximately $22.1 million for all three items. (Press Release 11/23/11)
Actavis launches generic Surmontil
Actavis announced that the FDA granted final approval for its ANDA for TrimipramineMaleate capsules, the AB-rated generic version of Duramed’s Surmontil. Annual U.S. brand sales are approximately $2.5 million for all three strengths. (Press Release 11/23/11)
PRODUCT AND LITIGATION UPDATES
Cephalon wins appeal againstWatson over generic Fentora
Teva’s Cephalon unit won an appeals court decision thatprevents Watson from selling a generic version of Fentora until 2019. The U.S. Court of Appeals for the FederalCircuit in Washington upheld the validity of a Cephalon patent on Fentora andbacked a lower court ruling that Watson infringed the patent. Fentora isapproved to relieve sudden episodes of cancer pain in adults already takingopioids, or morphine-like drugs. Cephalon has said the patent that was upheldexpires in 2019 and is for a process of making the tablet dissolve. Fentora had U.S. sales of approximately $81 million,Cephalon stated in August. (Bloomberg12/8/11)
Warner Chilcott sues Mylan over Generess Fe
Mylan announced that it and Famy Care had been sued byWarner Chilcott following their filing of an ANDA with the FDA for its genericversion of Warner Chilcott's Generess Fe. The application contains a paragraphIV certification, a legal assertion that patents covering Generess Fe areinvalid, unenforceable or won't be infringed. Between its April 2011 launch andSeptember 30, Generess Fe had sales of $4.5 million, according to IMS Health. (Drug Store News 12/1/11)
Perrigo receives final FDA approval for genericMucinex
Perrigo announced that it received final FDA approval for its ANDA for Guaifenesin Extended-Release Tablets, 600 mg. The new product will be packaged under store and proprietary brands that will compare to Mucinex tablets. Perrigo is still in litigation with Reckitt Benckiser, the New Drug Application holder and patent owner of Mucinex. Mucinex had sales of approximately $146 million through food, drug and mass merchandisers for thelast 12 months, as measured by Information Resources, Inc. (Perrigo Press Release 11/28/11)
Enbrel patent may undercut health care plan
Amgen announced that a new patent had been granted that could protect Enbrel from generic competition for 17 more years, a development that could undermine some of the savings contemplated in the federal health care legislation. The 2010 health care law established a way for biologic drugs, which can cost tens of thousands of dollars a year, to face competition from near generic versions, which are often called bio similars. A new law was needed as biologic drugs, which are made in living cells, were not covered by the 1984law governing most pharmaceutical competition. The main patent on Enbrel was set to expire in October of next year. But the new patent could delay biosimilar competition until November 22, 2028. By that time, Enbrel will have been on the market 30 years, far longer than the 20years of protection expected in patent law. The application for the new patent was filed in 1995, but it took until now to get through the Patent Office because it was reworked and at one point rejected, forcing Amgen to appeal. Patents now run 20 years from the date of application, to avoid situations where an invention gets extended protection due to delays or maneuvers at the patent office. However, since this patent was filed prior to the law changing, it is governed by the old rules and lasts for 17 years from the date of issuance. Amgen benefited from a similar situation with Epogen, which is still protected by patents even though it has been on the market since 1989. Enbrel had sales of $3.5 billion in the United States and Canada in 2010. (New York Times 11/23/11)
FDA approves Endo’s crush-resistantOpana ER
Endo announced the FDA approved a newformulation of Opana ER that is designed to be crush-resistant. Any alteration of the tablet in any mannercould pose significant risks of overdose or death. It isn't established thatthe new formulation is less subject to misuse, abuse, overdose or addiction,according to the company. Endo plans to transition its product in 2012 from thecurrent formulation to the new one. The new formulation will continue to becalled Opana ER with the same dosage strengths, color and packaging and similartablet size and shape. The company stated the FDA approval found no significantdifference in how the medication acts in its new form. (Wall Street Journal 12/12/11)
December 13, 2011
Pharmacy Administrative Account Information
Florida registration for 'Pharmacy Administrator Account'.
December 7, 2011
Caremark Pharmacy Audit Tips
Accurate Allowance for Partial Fills and Submission of Schedule II Medications.
December 7, 2011
Medicare Part D Newsletter
Medicare Part D Compliance Update for Community Pharmacies.
December 7, 2011
National Journal Report on ESI-Medco Hearing
PPSC would like to thank all the Senators that expressed their concerns during yesterday's Senate ESI-Medco merger hearing.
Read the Story
November 29, 2011
Congratulations Triangle Pharmacy & Twin City Pharmacy
Winners of the $2,500 Good Neighbor Pharmacy for Store Merchandising Support during PPSC's Appreciation Reception on July 21. PPSC hopes you enjoy the merchandise!
View Before & After Photos
Industry News - November 23, 2011
By: Kristen N. Reabe, Pharm.D
Industry News
POTENTIAL UPCOMING GENERIC LAUNCHES
Caduet: Launch expected December 1 by Mylan, with Ranbaxy as the authorized generic.
Clarinex Reditab: Launch expected early January by multiple suppliers, including Dr. Reddy's and Greenstone as the authorized generic.
Combivir: Exclusive launch expected late December by Teva.
Epivir: Launch may occur sometime in fourth quarter by Apotex.
Gastrocrom: Launch could occur anytime by Perrigo with Prasco as the authorized generic.
Lipitor: Launch expected November 30thby Watson, the authorized generic, and potentially Ranbaxy if granted FDA approval. Teva may also launch on this day.
Solodyn: Relaunch expected November 26 bymultiple suppliers including Global, Teva, Sandoz, Ranbaxy, Lupin, and Mylan.
Zanaflex Capsule: Launch may occur sometime infourth quarter.
RECENT LAUNCHES
Watson launches generic Kadian
Watson announced that it has received FDA approval for its ANDA for morphine sulfate extended-release capsules, the generic equivalent of Actavis' Kadian. Watson began shipping the product. Kadian is indicated to manage moderate to severe pain that continues around-the-clock and is expected to last for an extended period of time. For the most recent twelve months ending September 30, 2011, Kadian had sales of approximately $275 million, according to IMS Health data. (Watson PressRelease 11/11/11)
Actavis launches Kadian authorized generic
Actavis has launched morphine sulfate extended-release capsules, an authorized generic version of Kadian, which it also manufactures.The authorized generic product was launched on the same day as Watson's generic version. (DrugStoreNews 11/16/11)
PRODUCT AND LITIGATION UPDATES
Watson files for approval of generic Exelon
Watson filed for FDA approval for rivastigminetransdermal system patches, a generic version of Novartis' Exelon. The patches are used to treat mild to moderate dementia associated with Alzheimer's or Parkinson's disease. Exelon had sales of approximately $424 million during the 12-month period that ended in September, according to IMS Health. Novartis responded by filing a patent-infringement suit against Watson in order to prevent Watson from commercializing the patches before the expirations of three patents, which are set to occur in 2014 and 2019, according to FDA records. (DrugStoreNews 11/11/11)
Industry News - November 9, 2011
By: Kristen N. Reabe, Pharm.D
Industry News
POTENTIAL UPCOMING GENERIC LAUNCHES
Caduet: Launch expected December 1 byMylan, with Ranbaxy as the authorized generic.
Clarinex Reditab: Launch expected January 1 bymultiple suppliers, including Dr. Reddy’s.
Combivir: Exclusive launch expectedDecember 26 by Teva.
Gastrocrom: Launch could occur anytime byPerrigo with Prasco as the authorized generic.
Lipitor: Launch expected November 30thby Watson, the authorized generic, and potentially Ranbaxy if granted FDAapproval.
Solodyn: Relaunch expected in November bymultiple suppliers including Global, Teva, Sandoz, Ranbaxy, Lupin, and Mylan.
Xyzal OS: Launch expected November
RECENT LAUNCHES
FDA approves generic versions of Zyprexa
The FDA announced the approval of generic olanzapinetablets and olanzapine orally disintegrating tablets, respectively genericversions of Lilly's Zyprexa and Zyprexa Zydus. Dr. Reddy's and Teva will manufactureolanzapine tablets, while Dr. Reddy's, Apotex and Par will manufacture theorally disintegrating version. Prasco announced that it would partner with Lilly to makeauthorized generic versions of Zyprexa and Zyprexa Zydus, scheduled to launchat the same time as the generic versions. (DrugStore News 10/24/11)
GenericElestat launches
Apotexand Perrigo both received final FDA approval and are launching EpinastineOphthalmic Solution, generic versions of Allergan’s Elestat. Elestat is used toprevent ocular itching associated with allergic conjunctivitis. (Apotex Press Release 11/1/11, PBR 11/2/11)
Perrigolaunches generic Xyzal
Perrigoannounced they received final FDA approval for their ANDA for levocetirizinedihydrochloride oral solution, the AB-rated generic version of UCB’s Xyzal oralsolution. Xyzalis indicatedfor the treatment of indoor and outdoor allergies. This product had U.S. annualbrand sales of approximately $12 million. Prasco is the Authorized Generic. (Press Release 11/7/11)
PRODUCT AND LITIGATION UPDATES
Novenfiles lawsuit against Watson over generic Daytrana
NovenPharmaceuticals announced that it has filed a lawsuit against WatsonPharmaceuticals for infringement of certain Noven patents. The lawsuit wasfiled as a result of an ANDA submission by Watson seeking FDA approval tomarket and sell a generic version of Daytrana (methylphenidate transdermalsystem) prior to patent expiration in 2018. Under the Hatch-Waxman Act, the suit puts a stay of FDA approval onWatson's product for 30 months, or until Noven and Watson settle the matter.Watson is likely the first company to file for approval of a generic version ofDaytrana and as such, will have 180 days in which to compete directly withNoven once it wins final FDA approval. Daytranahad sales of more than $87 million during the 12-month period that ended inJuly, according to IMS Health.(PharmaLive10/14/11, Drug Store News 10/17/11)
Watson files ANDA for generic Atelvia
Watson has filed an ANDA with the FDA for risedronatesodium delayed-release tablet, a generic version of Warner Chilcott’s Atelvia.In response to the ANDA filing, Warner Chilcott filed suit to block Watson fromcommercializing generic Atelvia prior to patent expiration. The suit was filedunder the Hatch-Waxman Act, which puts a stay of FDA approval on Watson's productfor 30 months, or until the companies settle the matter. (DrugStoreNews 10/19/11)
Abbott and Impax settle patentlitigation over TriLipix
Abbott and Impax announced that they reached a deal tosettle patent litigation under which Impax is authorized to launch a genericversion of Abbott’s TriLipix (fenofibric acid) in January 2014, or as early asJuly 15, 2013 under certain circumstances. Abbott spokesman Scott Stoffel statedthe deal "allows Abbott to obtain certainty for our product and avoidcostly litigation around our patent." Abbott filed a lawsuit against Impaxlast year, alleging that Impax's planned generic version of the product wouldinfringe a US patent that is due to expire in 2025. Impax stated it believes itwas the first generic manufacturer to file an application with the FDA for ageneric version of TriLipix. Company spokesman Mark Donohue said that thesettlement removes the litigation risk surrounding their planned version of thedrug, and provides certainty on the launch date. TriLipix and TriCor, togetherhad combined sales of $1.2 billion for the first nine months of 2011. (FirstWord 10/21/11)
October 31, 2011
Radio Advertisements
Listen for radio advertising funded by PPSC, FIPN & AmerisourceBergen GNP encouraging all State of Florida Employees/Retirees patients to choose an HMO plan.
October 17, 2011
Medisca Press Release/Response
Darian Zaccardo, Medisca's VP Business Development & Sales, has offered a response to the court proceedings.
Read More
October 11, 2011
iPad 2 Winner - Congratulations, John Higgins from NC!
Pharmacists that registered for PPSC's advocacy network, PPSCAction, during the NCPA Tradeshow October 8-11, were all entered into a drawing for an iPad 2!
Industry News - September 29, 2011
By: Kristen N. Reabe, Pharm.D
Industry News
POTENTIAL UPCOMING GENERIC LAUNCHES
Gabitril: Launch expected September 30th by Caraco, who has 180 days of marketing exclusivity. An authorized generic is possible as well.
Lipitor: Launch expected November 30th by Watson, the authorized generic, and potentially Ranbaxy if granted FDA approval.
Zyprexa: Launch expected October 23rd for all formulations. Teva is expectedto be exclusive on the tablets, with an authorized generic possible.
RECENT LAUNCHES
Glenmark launches generic Malarone
Glenmark announced that the FDA granted final approval for their ANDA for atovaquone tablets, a generic version of GlaxoSmithKline’s Malarone. Glenmark is launching with 180 days of marketing exclusivity. Annual sales of Malarone areapproximately $60 million. (Press Release 9/15/11)
Par launches generic Ultram ER
Par announced that the FDA granted final approval for their ANDA for Tramadol Hydrochloride extended release Tablets in the 300mg strength. Par launched the generic 100mg and 200mg strength Ultram ER tablets in November 2009. This product is the AB-rated generic version of Johnson & Johnson’s UltramER. Patriot will launch as the authorized generic. Annual sales of Ultram ER are approximately $60 million. (Press Release 9/21/11)
PRODUCT AND LITIGATION UPDATES
Qualitest recalls oral contraceptives
Qualitest has recalled multiple lots of oral contraceptives due to a packaging error that could lead to incorrect dosing and unintended pregnancies. The company stated the error caused the weekly tablet orientation to be reversed and obscured thelot number and expiration date on certain packages. The problem could lead to inadequate contraception if women don't get the proper daily regimen of the drug. The recall affects certain lots of Cyclafem, Emoquette, Gildess, Orsythia, Previfem and Tri-Previfem. Doctors, pharmacists and patients seeking more information can contact Qualitest at 1-877-300-6153. (Associated Press 9/16/11)
Cephalon sues Sandoz over Fentora
Cephalon has filed suit against Sandoz, accusing it of trying to infringe two patents related to Fentora. In a complaint filed in the U.S. District Court in Wilmington, Delaware, Cephalon stated Sandoz has applied with the FDA to sell fentanyl citrate buccal tablets, a generic version of Fentora. Cephalon said it advised Sandoz in June that its generic version would infringe two patents held by Cima Labs, a unit ofCephalon. Sandoz nonetheless "has made, and continues to make, substantial preparation to sell the generic version in the United States," and Cephalon and Cima will be "irreparably harmed" if this were to continue, the complaint said. The lawsuit seeks a permanent halt to any infringement, monetary damages and other remedies. Sales of Fentora totaled $97.8 million from January to June. (Reuters 9/16/11)
FDA approves second Lovenox generic
The FDA approved a second generic version of Lovenox from Amphastar and Watson. The approval comes a year after the FDA approved Momenta's generic formulation, called enoxaparin. Amphastar plans to start selling its product in the fourth quarter of this year, according to Watson. Working in a partnership, Amphastar will provide the drug to Watson, which will market it in the U.S. In the year that ended on July 30, Lovenoxand its generic equivalents had U.S. sales of approximately $2.6 billion, according to IMS Health. (Reuters 9/19/11)
OTC asthma inhalers containing CFCs will no longer be sold after Dec. 31, 2011
The FDA stated users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product as these inhalers will not be made or sold after December 31, 2011. Epinephrine inhalers, marketed by Armstrong as Primatene Mist, are the only FDA-approved inhalers for the temporary relief of occasional symptoms of mild asthma that are sold over-the-counter in retail stores without a prescription. The product uses CFCs as a propellant and will no longer beavailable by year’s end to comply with an international agreement to phase-out substances that deplete the ozone layer, including CFCs, after certain dates. (PharmaLive 9/23/11)
October 7, 2011
Changes to AWP Reimbursement for Medicaid
Florida Medicaid SMAC Pricing Changes From AHCA Staff.
Read More
September 30, 2011
State of Florida's Employee & Retiree - FAQ HMO Procurement
Important Enrollment Changes Regarding The State of Florida's Employee and Retiree Program.
Read More
September 30, 2011
State of Florida's Employee & Retiree - FAQ Prescription Drug Plan Network
Important Enrollment Changes Regarding The State of Florida's Employee and Retiree Program.
Read More
Industry News - September 14, 2011
By: Kristen N. Reabe, Pharm.D
Industry News
POTENTIAL UPCOMING GENERIC LAUNCHES
Gabitril: Launch expected September 30th by Caraco, who has 180 days of marketing exclusivity. An authorized generic is possible as well.
Lipitor: Launch expected November 30th by Watson, the authorized generic, and potentially Ranbaxy if granted FDAapproval.
Malarone: Launch expected September 30th by Glenmark exclusively. An authorizedgeneric is possible as well.
Zyprexa: Launch expected October 23rdfor all formulations. Teva is expected to be exclusive on the tablets, with an authorized generic possible.
RECENT LAUNCHES
Perrigoreceives FDA generic drug approval
Perrigo announced the FDA approved its genericversion of Extina foam. Perrigo stated it started shipping the product. Extinafoam has annual sales of approximately $10 million. (Associated Press 8/30/11)
Watson Launchesgeneric Keppra XR
Watson confirmedthat it has launched Levetiracetam Extended-Release 500mg and 750mg tablets,the generic version of UCB's Keppra XR following FDA approval of its ANDA. Watson has begun shipping the product. Keppra XR is indicated totreat partial onset seizures in people 16 years of age and older with epilepsy.For the twelve months ending July 31, 2011, Keppra XR had total U.S. sales ofapproximately $163 million, according to IMS Health data. (Watson Press Release 9/14/11)
Lupin launches generic Keppra XR
Lupin announced it received final FDA approval ANDA to market ageneric version of UCB's Keppra XR Tablets. Lupin stated the commercialshipment of the product had commenced.(RTTNews 9/14/11)
Amneal launches generic version of Felbatol
Amneal announced that the FDA granted final approval for their ANDA for felbamate tablets, thegeneric version of Meda’sFelbatol. Annual sales of Felbatol areapproximately $30 million. (Press Release 9/13/11)
PRODUCT AND LITIGATION UPDATES
Lupin receives final approval for generic Ultram ER
Lupin Pharmaceuticals announced that it received final FDA approval for its ANDA forTramadol Hydrochloride Extended-Release 100mg, 200mg, and 300mg Tablets, thegeneric equivalent to Ortho-McNeil's Ultram ER. According to IMS Health data, Tramadol HCl ER tablets had annual salesof approximately $132 million for the twelve months that ended June 2011. (PharmaLive 8/31/11)
Pfizer settlesLipitor suit With Dr. Reddy’s
Pfizer settled a patent-infringement lawsuit with Dr. Reddy’s overLipitor and the specific terms were not disclosed. Pfizer sued Dr. Reddy’s inDecember 2009 to prevent a generic launch of Lipitor prior to Pfizer’s patent expirationin 2017. The companies settled on August 19, and a U.S. District Judgedismissed the case August 29, according to court records. The agreement issubject to review by the U.S. Justice Department and the Federal TradeCommission. Teva and Mylan also have reached settlements with Pfizer for theirgeneric versions of Lipitor. Ranbaxy was the first company to seek regulatoryapproval for a generic and had planned to enter the market on November 30, withTeva, Mylan and other generic suppliers beginning sales six months later aspart of its deal with Pfizer. An FDA investigation into quality standards attwo Ranbaxy plants and a federal probe of its testing practices have delayedapproval. Analysts have stated that Ranbaxy may have to sell its rights to bethe only approved generic on the market if it can’t pass regulatory approval byNovember. Watson has a separate agreement with Pfizer that would allow it tosell the authorized generic beginning November 30. The Watson product doesn’t requireFDA approval and would not be affected by the Ranbaxy deal. (Bloomberg 8/31/11)
Ranbaxy to launch generic Lipitor at end of November
Ranbaxy will launch its generic version of Lipitor as originally planned atthe end of November, according to published reports. Though the November launchhad long been anticipated, speculation arose that Ranbaxy would have to sellrights to the drug due to manufacturing problems in India that had led the FDAto ban imports of some of its products. According to IMS Health, Lipitor hadU.S. sales of $7.2 billion last year. Under the Hatch-Waxman Act of 1984, asthe first company to win approval of a generic version of Lipitor, Ranbaxy willhave exclusive marketing rights for the generic for 180 days, in directcompetition with Pfizer. Ranbaxy is expected to face additional competition inthe form of an authorized generic marketed by Watson. (Drug Store News 9/9/11)
Federal courtrules for Allergan in patent dispute over Lumigan
A federal judge has ruledthat Allergan’s patent on Lumigan is valid and was infringed upon by twogeneric versions. U.S. District CourtJudge Sue Robison ruled that Barr and Sandoz failed to prove that Allergan’spatents protecting Lumigan were invalid. Barr and Sandoz filed regulatoryapplications to make generic versions in 2009 and Allergan then sued thecompanies for patent infringement. Lumigan has annual sales of approximately$650 million. (Reuters 9/9/11)
August 26, 2011
Pharmacy Select Customers: Covidien has redesigned the bottle on the Hydrocodone Solution.
August 16, 2011
Important information regarding tamper resistant pads for Medicaid prescriptions.
August 16, 2011
User Guide for the Controlled Substances Reporting System Version 3
August 3, 2011
Outcomes' Medication Therapy Management (MTM) Program announces immunization-related services are now covered
July 19, 2011
PCAN Press Conference: Coalition Calls on AHCA to Protect Taxpayers, Medicaid Patients & Community Based Pharmacies
July 6, 2011
By: Kristen N. Reabe, Pharm.D; Vice President of Pharmacy Select
Potential Upcoming Generic Launches
Uroxatral: Launch expected July 18th by multiple suppliers including Ranbaxy, Apotex, Mylan, Actavis, Greenstone, Teva, and Aurobindo.
Zyprexa: Launch expected October 23rd with Teva having exclusivity on certain strengths and Dr. Reddy’s exclusive on others.
PRODUCT AND LITIGATION UPDATES
Pfizer sues Aurobindo over Lipitor
On June 27, Pfizer sued Aurobindo over its generic version of Lipitor. Aurobindo may opt for out-of-court settlement with Pfizer. Pfizer has sued several generics manufacturers over Lipitor and argued that patents covering Lipitor grant it exclusive production right until 2017. Pfizer requested the court to refrain Aurobindo from manufacturing and marketing of its generic version prior to January 8, 2017, the date of expiration of the patent, including the period of exclusivity granted to Lipitor. Ranbaxy reached an agreement with Pfizer to settle most of their patent litigations over Lipitor in 2008. The pact allows Ranbaxy to sell its generic versions of Lipitor and Caduet in the U.S. effective November 30, 2011. Dr. Reddy's is also facing a patent infringement suit from Pfizer over Lipitor. (PTI 6/30/11)
Impax settles suit with Daiichi and Genzyme
Impax announced it settled a lawsuit with Daiichi Sankyo and Genzyme, related to Impax's generic version of Welchol. According to the terms of the settlement, Impax will be permitted to launch its tablet product on March 2, 2015 or earlier, under certain circumstances. The litigation will also be dismissed. Impax believes it was the first to file for approval of a generic version, and expects to get at least three months of market exclusivity prior to the launch of additional generics. According to Wolters Kluwer Health, U.S. sales of Welchol tablets and Welchol oral suspension were approximately $325 million and $65 million for the year that ended May 2011. (Reuters 6/30/11)
INDUSTRY UPDATES
Errors occur in 12% of Electronic Drug Prescriptions
As many as 12% of the drug prescriptions sent electronically to pharmacies contain errors, according to a report published in the Journal of the American Medical Informatics Association. The rate was consistent with past studies reviewing the risk of errors when a doctor writes a prescription and gives it to the patient, according to the researchers. The results undermine the expected safety benefits from computer-generated prescriptions. (Bloomberg 7/5/11)
FDA bans import of drugs from Dr. Reddy's Mexico plant
The FDA has imposed an import ban on products made at Dr. Reddy's Mexican plant for violation of current good manufacturing practices. The company's Mexican facility, which produces intermediates and active pharmaceutical ingredients had received a warning a letter from the FDA last month. The import ban follows a warning letter issued by the FDA on June 3. The regulator cited "lack of corrective actions" by the firm after it had sought certain explanations following an inspection of the company's Mexico facility in November 2010. (The Economic Times 7/6/11)
July 1, 2011
Important notice from the Florida Department of Health concerning Florida's Prescription Drug Monitoring Program
Industry News - June 29, 2011
Recent Launches
Mylan's launches generic Entocort EC
Mylan announced the U.S. District Court for the District of Delaware ruled that Mylan’s ANDA for budesonide capsules does not violate the patent for AstraZeneca’s Entocort EC. The FDA approved Mylan’s product last month, and the company stated it plans to launch immediately. Par is also launching as the authorized generic. Budesonide capsules had sales of approximately $350 million for the 12 months that ended in March, according to IMS Health. (Drug Stores News 6/24/11)
PRODUCT AND LITIGATION UPDATES
Depomed files lawsuit against Sun
Depome has filed a lawsuit against Sun Pharmaceuticals for infringement of patents for Depomed's 500mg and 1000mg Glumetza (metformin hydrochloride extended release tablets). The lawsuit is in response to an ANDA filed by Sun with the FDA regarding Sun's intent to market generic versions of the 500mg and 1000mg strengths of Glumetza prior to the expiration of the five listed US patents. Depomed has commenced the lawsuit within the 45 days required to automatically delay the FDA from approving Sun's ANDA for 30 months or until a district court decision that is adverse to the patents, whichever may occur earlier. (American Chronicle 6/23/11)
INDUSTRY UPDATES
Walgreens to no longer participate in Express Scripts network in 2012
Walgreens announced the company will no longer participate in the Express Scripts network beginning January 1, 2012, citing unsuccessful renewal negotiations. "Under the terms proposed by Express Scripts, it would not make good business sense for the strategic direction of our company to continue our relationship with them,” Walgreens president and CEO Greg Wasson said. “As the largest retail provider in their pharmacy network, we were surprised by Express Scripts' ultimate stance during our talks, which made it clear to us that they no longer had an interest in continuing a meaningful relationship." The move eliminates nearly 8,000 pharmacies from the PBM’s network, including all Walgreens locations and Duane Reade locations in New York. According to Walgreens, negotiations broke down for several reasons. For example, Express Scripts insisted on being able to unilaterally define contract terms, including what does and does not constitute a branded and generic drug. Walgreens also charged that Express Scripts proposed to cut reimbursement rates to “unacceptable levels” below the industry average cost to provide each prescription. (Drug Store News 6/21/11)
Industry News - June 22, 2011
Recent Launches
Teva launches generic Nasacort AQ
Teva began shipping a generic version of Sanofi’s Nasacort AQ (triamcinolone acetonide nasal spray). Nasacort AQ is used to treat nasal symptoms of seasonal and year-round allergies in patients ages 6 years and older. Winthrop also launched the authorized generic. Nasacort AQ had sales of $226 million during the 12-month period that ended in May, according to Wolters Kluwer. (Drug Store News 6/15/11)
Generic Levaquin launches
The FDA approved the first generic versions of Johnson & Johnson's Levaquin, which treats bacterial infections that cause bronchitis or pneumonia as well as infections of the skin, sinuses, kidney, bladder and prostate. Regulators approved applications from 12 manufacturers for generic versions of the drug. Those companies include Akorn, Dr. Reddy's, Mylan, Aurobindo, andTeva. HiTech received FDA approval as well as 180 days of exclusivity for the oral solution. (The Associated Press 6/20/11)
PRODUCT AND LITIGATION UPDATES
Watson seeks to FDA approval for generic Avodart
Watson is seeking FDA approval to sell a generic version of GlaxoSmithKline's (GSK) Avodart. GSK filed a lawsuit against Watson in the U.S. District Court for the District of Delaware seeking to stop the move. The lawsuit prevents the FDA's final approval of Watson's application until November 17, 2013, or until a resolution of the case in court.
Avodart had U.S. sales of approximately $580 million in the 12 months that ended April 30, according to Watson. (Associated Press 6/20/11)
Teva sues Apotex for Azilect patent infringement
Teva has filed a patent infringement lawsuit against Apotex after Apotex applied to the FDA to market a generic version of Teva’s Azilect. Azilect had $318 million in sales in 2010, and $90 million in sales in the first quarter of 2011. Teva's statement of claim says that Azilect's patents are valid through February 2017.
Eight months ago, Teva sued Watson, Mylan, and Orchid, after they applied for FDA approval for their generic versions. Under US law, the defendants cannot market their generics until November 2013, or until the court rules in their favor. (Globes 6/13/11)
Watson confirms Pataday patent challenge
Watson filed an ANDA with the FDA seeking approval to market Olopatadine Hydrochloride Ophthalmic Solution, a generic version of Alcon’s Pataday. Alcon filed suit against Watson on June 9, 2011, seeking to prevent Watson from commercializing its product prior patent expiration. Alcon’s lawsuit was filed under the provisions of the Hatch-Waxman Act, preventing final FDA approval of Watson’s ANDA until October 29, 2013, or until final resolution of the matter before the court. For the twelve months ending April 30, 2011, Pataday had total U.S. sales of approximately $224 million, according to IMS Health data. (PharmaLive 6/20/11)
Lupin files ANDA for generic Vimovo
Pozen announced that Lupin has filed for FDA approval for its generic version of Vimovo. In a regulatory filing, Pozen stated the company and its partner AstraZeneca are reviewing the notice and intend to defend their patent from any infringement. Vimovo is a fixed-dose combination of naproxen and an immediate release version of esomeprazole. Dr. Reddy’s also filed for FDA approval for its generic in March of this year. (Reuters 6/16/11)
U.S. court denies Teva’s motion on generic Copaxone
A U.S. district court denied Teva’s motion for a summary judgment finding of no inequitable conduct in relation to a patent infringement lawsuit brought against Mylan in relation to Copaxone (glatiramer acetate). Teva filed the motion as part of efforts to prevent Mylan from launching a generic version of the multiple sclerosis drug. A start date of July 11 was set for the trial regarding the company’s inequitable conduct affirmative defense. A trial on the remaining issues relating to the product will begin September 7. Teva is suing Mylan, Momenta, Sandoz, and Natco for patent infringement of Copaxone, which generated sales of $3 billion in 2010. (FirstWord 6/19/11)
Watson temporarily barred from selling generic Seasonique
Teva won an appeals court order that temporarily prevents Watson from selling a generic version of Seasonique. The temporary ban allows the U.S. Court of Appeals to consider whether sales should be halted further until it rules on a separate appeal by Teva to block Watson’s generic version. Watson has until July 1 to respond. Watson, which planned to launch its generic as soon as June 20, “will oppose this motion to appeal and seek to be able to launch the product,” stated Charlie Mayr, a Watson spokesperson. Teva contends that Watson’s generic would infringe a patent that expires in 2024, and wanted to ensure Watson cannot bring its version to market prior to then. (Bloomberg 6/19/11)
INDUSTRY UPDATES
Dr. Reddy's Mexico facility receives FDA warning letter
Dr. Reddy's announced the FDA has warned the company that its Mexico unit has violated good manufacturing practices. The FDA's warning letter cited four specific deviations at the facility and asked Dr. Reddy's to first determine their cause and then prevent them from recurring. The FDA also warned that it might not approve the sale of drugs that list the Dr. Reddy's facility as the ingredients manufacturer as well as ban the entry of products made at the facility into the U.S. until the issues were resolved to its satisfaction. The warning letter, dated June 3, gives Dr. Reddy's 15 working days from its receipt to notify the agency in writing of the specific steps that have been taken to address the regulatory issues. Dr. Reddy's said it will respond to the FDA within the stipulated time frame. The FDA had inspected the Mexico facility in November 2010 and had issued observations, asking the company to correct the deviations from the regulator's manufacturing practice norms. The letter said Dr. Reddy's December 1, 2010 response to the 483 observations "lacks sufficient corrective actions." (Dow Jones 6/14/11)
J&J recalls 40,000 bottles of Risperdal
Johnson & Johnson announced it has recalled 16,000 bottles of Risperdal and another 24,000 bottles of a generic formulation due to consumer reports of odors in the products. The company stated the recalls stem from odors believed caused by trace amounts of a chemical called TBA found in pallets used to transport and store materials. Last year, J&J recalled a number of OTC products, including Tylenol, Motrin, and Benadryl, due to the same musty or moldy odor linked to the chemical. "While not considered to be toxic, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor," J&J stated. J&J said the recalled generic formulation of Risperdal (risperidone) was sold by the company's Patriot Pharmaceuticals unit. (Reuters 6/17/11)
Abuse-resistant Oxycodone approved
Oxecta, an abuse-resistant form of oxycodone, has been approved by the FDA. The immediate-release medication contains niacin, which is designed to cause uncomfortable flushing and skin irritation if a person takes more than the recommended amount. Oxecta is similar to Purdue’s Oxycontin. Oxecta shouldn't be used in people who have severe asthma, upper-airway obstruction or chronic obstructive pulmonary disease (COPD), according to drug makers Pfizer and Acura Pharmaceuticals in a news release. Common adverse reactions include nausea, constipation, vomiting, headache, itchiness, insomnia, dizziness and lack of energy. (HealthDay News 6/20/11)
June 16, 2011
Letter from the Florida Department of Health on HB 7095 & HB 1319. This letter will be mailed to every Florida licensed Pharmacist and Pharmacy
June 16, 2011
HB 7095 - Bill Requires Wholesalers to Play Role in Reducing Pill Mills
Industry News - June 10, 2011
Potential Upcoming Generic Launches
Rhinocort AQ: Potential launch in July by Teva and Apotex, with Par as the authorized generic.
Levaquin: Potential launch date of 6/20/11 by multiple suppliers.
RECENT LAUNCHES
12 new generic versions of Femara launched
The FDA has approved a dozen new generic versions of Novartis’ Femara (letrozole). Suppliers now include Teva, Dr. Reddy’s, Sun, Impax, Endo, Roxane, Accord, Synthon, and Natco, as well as others. The agency originally approved Mylan’s version of the drug in December 2008, but Mylan did not launch until April 21 of this year. Femara had sales of $682 million in 2010, according to IMS Health. (Drug Store News 6/6/11)
PRODUCT AND LITIGATION UPDATES
FDA approves Watson’s generic Lybrel
The FDA has approved Watson’s levonorgestrel and ethinyl estradiol tablets in the 0.09-mg/0.02-mg strength. The drug is a generic version of Pfizer’s Lybrel, which had sales of slightly less than $12 million during the 12-month period that ended in April, according to IMS Health. (DrugStoreNews 6/7/11)
Watson confirms Viagra patent challenge
Watson confirmed that it filed an ANDA with the FDA seeking approval to market Sildenafil Citrate Tablets, a generic version of Pfizer’s Viagra. Pfizer filed suit against Watson on June 1, 2011 in the United States District Court for the Southern District of New York seeking to prevent Watson from commercializing its product prior to patent expiration. (FirstWord 6/2/11)
Impax files for approval for generic Detrol
Impax announced that it is seeking FDA approval for its generic version of immediate-release Detrol (tolteridine) and is being sued by Pfizer. The company stated Pfizer has filed suit against Impax for patent infringement. Pfizer's lawsuit prevents the FDA from approving Impax's product for 30 months, or until the lawsuit is resolved. The patents supporting Detrol begin to expire in March 2012, although a court could void those patents. U.S. sales of immediate-release Detrol were $62 million in the 12 months that ended in March, according to Impax. (Associated Press 6/3/11)
INDUSTRY UPDATES
Impax receives FDA warning letter
Impax announced that it received a warning letter from the FDA regarding manufacturing practices at its plant in Hayward, California. FDA inspectors found problems during a review in the company's sampling and testing, its production record review, and the process it used to determine why manufacturing batches did not meet quality specifications. Based on the inspection results, Impax recalled five production lots of fenofibrate in March. The FDA's inspection was conducted between December 13, 2010 and January 21, 2011. Impax stated it reviewed its manufacturing practices after the inspection and will work to address the FDA's concerns. It is required to respond to the FDA's warning letter within 15 business days. The warning letter does not affect its ability to make and ship products, but the company said marketing applications that involve the Hayward plant could be delayed. Impax added that it reduced production at the Hayward plant so it could make changes, and it has now resumed production at a normal pace. (The Associated Press 6/6/11)
FDA limits high-dose Zocor
The FDA instituted a new limit on the 80mg dose of Zocor (simvastatin) due to an elevated risk of muscle injury, which can lead to potentially dangerous consequences. The FDA also gave a list of drugs with which Zocor should not be prescribed and changed the top dose of Vytorin. The news does not impact the other doses of Zocor or Vytorin. According to IMS Health, Zocor was prescribed 94 million times in 2010, double the number of prescriptions in 2007. Merck says only 12% of patients were taking the 80mg dose, however. While the FDA is saying new patients should not be started on the 80mg dose, it is not saying that those who have been taking the medication should switch, because the side effects are most likely in the first year of treatment. (Forbes 6/9/11)
June 6, 2011
Flexible Spending Accounts and your independent business… What does it mean for you?
June 6, 2011
FPA Stat News for June 6th
June 6, 2011
Recap of NCPA's 43rd Annual Legislative Conference.
Industry News - June 2, 2011
Potential Upcoming Generic Launches
Rhinocort AQ: Potential launch in July by Teva and Apotex, with Par as the authorized generic.
Levaquin: Potential launch date of 6/20/11 by multiple suppliers.
RECENT LAUNCHES
Impax launches generic Adoxa
Impax Laboratories announced that the FDA granted final approval of their ANDA for its generic version of Adoxa (doxycyline monohydrate, 150 mg capsules). Impax will launch through Global Pharmaceuticals, Impax’s generic division. Adoxa is a tetracycline antibiotic used to treat bacterial infections. According to Wolters Kluwer Health, U.S. sales of Adoxa were approximately $25 million in the 12 months ending December 2010. Par is launching the authorized generic. (Press Release 5/31/11)
PRODUCT AND LITIGATION UPDATES
Teva to market generic Combivir
Teva announced it will launch generic Combivir tablets (lamivudine and zidovudine) and is eligible for a 180-day period of marketing exclusivity, according to the FDA. Teva is expected to begin shipping in fourth quarter 2011, per terms of a settlement agreement between Teva, Glaxo Group and ViiV Healthcare. Combivir tablets had annual U.S. sales of approximately $315 million, according to IMS sales data. (DrugStoreNews 5/27/11)
InSite announces joint patent infringement lawsuit against Sandoz
InSite Vision Incorporated announced that it will join Merck and Pfizer in filing a patent infringement lawsuit against Sandoz. Sandoz recently filed an ANDA with the FDA seeking to market a generic version of AzaSite (azithromycin 1% ophthalmic solution) before expiration of the patents covering AzaSite and its use. AzaSite is marketed by Inspire in the US, now a wholly-owned subsidiary of Merck. Sandoz filed an ANDA application for AzaSite with the FDA of which InSite received notice on April 18, 2011, and InSite has 45 days to file a patent infringement lawsuit. With this filing, that time requirement has been met. This lawsuit also triggers an automatic bar of the FDA's approval of the ANDA for up to 30 months or until a final court decision of the infringement lawsuit, whichever comes first. (American Chronicle 5/31/11)
INDUSTRY UPDATES
Watson acquired Specifar Pharmaceuticals
Watson announced that it acquired Greek generic manufacturer Specifar Pharmaceuticals for $563 million in cash. Watson CEO Paul Bisaro stated that through the deal, the company “gains a substantial commercial position in the Greek branded-generic market”. The transaction will increase Watson’s “presence in key European markets by providing a portfolio of approved products” under the Specifar and Alet Pharmaceuticals brands. Specifar had annual revenue of approximately $120 million last year. Watson also noted the Specifar’s pipeline includes a generic version of AstraZeneca’s Nexium (esomeprazole), which could be launched in certain European markets in the fourth quarter of the year. (FirstWord 5/25/11)
May 31, 2011
2011 Proper Coding for sanofi pasteur products. Includes NEW vaccine administration codes effective January 1, 2011
Industry News - May 25, 2011
Potential Upcoming Generic Launches
Rhinocort AQ: Potential launch in July by Teva and Apotex, with Par as the authorized generic.
RECENT LAUNCHES
Nostrum launches generic Carbatrol
Nostrum announced that they received final FDA approval for their ANDA for Carbamazepine Extended Release Capsules, the AB-rated generic version of Shire’s Carbatrol. Nostrum is currently the only generic supplier in the market. Carbatrol is indicated for use as an anticonvulsant drug and had annual brand sales of $120 million. (Press Release 5/19/11)
Mylan launches generic Amrix
Mylan announced the launch of cyclobenzaprine hydrochloride extended release capsules, the generic version of Cephalon’s Amrix. Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for cyclobenzaprine ER capsules, and was awarded 180 days of marketing exclusivity. Amrix had sales of approximately $125 million during the 12-month period that ended in March, according to IMS Health. (Drug Store News 5/16/11, PRNewswire 5/17/11)
Watson launches authorized generic of Amrix
Watson has launched an authorized generic version of Amrix (Cyclobenzaprine Hydrochloride Extended-Release Capsules) as part of an agreement with Anesta AG, a subsidiary of Cephalon. Amrix is approved for use along with rest and physical therapy to help control muscle spasm associated with acute, painful musculoskeletal conditions. (PRNewswire 5/17/11)
Cephalon wins restraining order against Mylan
Cephalon announced that a U.S. district court judge granted its request for a restraining order preventing Mylan from launching a generic version of Amrix. The temporary restraining order was granted by the U.S. District Court for the District of Delaware. Cephalon and Mylan have been involved in a series of lawsuits since 2008 over the rights to market Amrix, an extended-release muscle relaxant. Mylan claims its generic version of the drug would not infringe on patents held by Cephalon. "We remain confident in the strength of the patents protecting Amrix and believe we have a strong case on appeal," said Jerry Pappert, general counsel for Cephalon. (The Associated Press 5/20/11)
Mylan launches generic Xibrom
Mylan announced the exclusive launch of bromfenac ophthalmic solution, under a development and supply agreement with Coastal Pharmaceuticals. The drug is a generic version of ISTA’s Xibrom Ophthalmic Solution. Various versions of bromfenac ophthalmic solution had sales of approximately $116 million during the 12-month period that ended in March, according to IMS Health. (Drug Store News 5/16/11)
Amneal launches generic Furadantin OS
Amneal launched nitrofurantoin suspension, its generic version of OSG Norwich Pharmaceuticals’ Furadantin OS. Amneal is currently the only supplier of the generic product in the market. Having total U.S. brand sales of more than $40 million, Furadantin suspension is an antibiotic used in the treatment of bladder infections. (Press Release 5/12/11)
PRODUCT AND LITIGATION UPDATES
Breckenridge announces settlement of Actos litigation
Breckenridge announced that they have reached an agreement with Takeda resolving patent litigation related to Pioglitazone Hydrochloride, a generic version of Actos. Under the terms of the agreement, Takeda granted Breckenridge and Synthon a non-exclusive, royalty-free license to its U.S. patents covering Actos, permitting launch of their generic after generic suppliers with ANDAs with paragraph IV certifications exhaust their 180-day marketing exclusivity on February 13, 2013, or earlier under certain circumstances, subject to regulatory approval. Breckenridge and Synthon signed a distribution and supply agreement on the product in late 2009 and have been working together on this product, including the settlement of the paragraph IV litigation. Actos had approximately $3.4 billion in brand sales for the twelve months ending December 31, 2009, according to IMS Health. (PharmaLive 5/17/11)
Genentech sues Apotex over Valcyte
Roche’s Genentech unit sued Apotex for planning to sell a generic version of Valcyte prior to Genentech’s patent expiring. Apotex informed Genentech on April 6 that it had applied for FDA approval to make a generic of Valcyte, according to the complaint filed in federal court in San Francisco. Genentech stated the plan to market the generic will cause “massive infringement” of its patent covering the drug. Genentech seeks a court order declaring that the Apotex generic is a patent-infringing drug, preventing the FDA from approving it until Genentech’s patent expires in 2015 and barring Apotex from engaging in commercial activity that would infringe the Genentech patent. Genentech filed a suit based on similar claims against Sandoz last month. In addition, Roche settled a lawsuit with Ranbaxy last year with Ranbaxy agreeing to sell its generic in 2013, two years before a patent expires. (Bloomberg 5/17/11)
INDUSTRY UPDATES
FDA reports new restrictions for Avandia
The FDA announced in a drug safety communication that GlaxoSmithKline's rosiglitazone-containing drugs, Avandia, Avandamet, and Avandary, will only be available to patients through a restricted access and distribution program. The new restrictions are part of a Risk Evaluation and Mitigation Strategy program that was determined by the agency last September and was based on data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone.
The agency indicated that the drugs will no longer be available in retail pharmacies in the US beginning November 18. The drugs can only be used by patients who are already taking them successfully and who can’t control their glucose levels with other diabetes drugs, including Takeda's Actos, the FDA stated. Avandia generated sales of $680 million last year, a decrease from peak annual sales of $3 billion. (FirstWord 5/19/11)
Growth of prescription drug spending to drop due to generics
According to a study by IMS Health, the annual growth rate for spending on prescription drugs may fall to between 3 percent and 6 percent through 2015, mainly due to the increased use of generic medications. The report noted that while worldwide spending on drugs will reach almost $1.1 trillion by 2015, the growth rate will be below the 6.2 percent seen over the last five years. The 2008 global financial recession, as well as recent government measures to control drug prices in countries such as China, Italy and Japan, also are reasons for the slowing growth rate. According to the report, yearly sales of drugs in the U.S. will grow in the range of 0 percent to 3 percent through 2015, while European revenue will rise between 1 percent and 4 percent. Although spending on branded drugs is expected to remain stagnant in developed markets over the period, growth will be seen for generic medications. The report estimated that as products, including Pfizer's Lipitor (atorvastatin) and Sanofi and Bristol-Myers Squibb's Plavix (clopidogrel) lose patent protection, generic versions of the drugs could lead to net savings of $98 billion to insurers in developed countries through 2015. The market share for branded medications is anticipated to fall to 53 percent in 2015, from 64 percent last year. (FirstWord 5/19/11)
Aurobindo faces further scrutiny from FDA
The FDA has found another manufacturing unit of Aurobindo to be deficient in meeting its standards. The FDA has asked Aurobindo to submit a detailed action plan for the improvement of packaging and labeling compliance at its Unit III facility. This facility is located near Hyderabad City in southern India and makes finished forms of non-penicillin and non-cephalosporin drugs. The FDA also issued a warning to the company regarding its Unit VI facility, Aurobindo reported, without specifying what the warning was. Three months ago, the FDA banned shipments from Unit VI, which makes cephalosporin products. Aurobindo is required to submit its report on Unit III within 15 working days and the FDA has given an opportunity for a regulatory meeting at its office. Aurobindo is requesting a meeting date and is in the process of submitting a plan, according to a company statement. (Wall Street Journal 5/23/11)
Par to buy Edict Pharmaceuticals
Par will acquire India-based generic drug manufacturer Edict Pharmaceuticals for up to $37.6 million. The company expects the deal to close by the end of the year. Edict develops and manufactures solid oral dosage generic drugs with a focus on niche first-to-file, first-to-market formulations. The company has eight ANDAs pending FDA approval, one application filed in the name of a development partner, and fourteen products in development. Par President Paul. V. Campanelli stated Par has a long-standing relationship with Edict after the two companies collaborated on numerous current Par products. (Wall Street Journal 5/23/11)
May 23, 2011
Prohibition on Physician Dispensing Schedule IIs and IIIs
May 23, 2011
Pharmacy Practice Impacted by the Pill Mill Bill- House Bill 7095
May 17, 2011
Take the 2011 NCPA Digest Survey. You have until May 31!
Industry News - May 13, 2011
Potential Upcoming Generic Launches
Adoxa: Potential launch in mid-May by Global with Par as the authorized generic.
Carbatrol: Potential exclusive launch by Teva in July.
Levaquin: All forms are expected to launch June 20 by multiple suppliers.
Rhinocort AQ: Potential launch in third quarter by Teva and Apotex, with Par as the authorized generic.
INDUSTRY UPDATES
Apotex to resume shipping of oral solid dose products to US
Apotex announced it will soon resume shipments of its oral solid dose products to the U.S. market. The announcement follows the FDA’s decision to lift its import alert at Apotex’s largest solid dose manufacturing facility supplying product to the U.S. “Apotex is pleased the FDA has recognized the enhancements to our global quality systems,” stated Dr. Jeremy B. Desai, Apotex’s Chief Operating Officer. Apotex will immediately resume manufacturing and shipping its solids dose products into the U.S. market. (Apotex Press Release 5/9/11)
Perrigo to settle litigation over generic Cutivate
Perrigo has reached a licensing agreement with Nycomed that will allow it to launch a generic version of Cutivate Lotion in 2012. Perrigo announced it agreed to settle all Hatch-Waxman litigation relating to its fluticasone lotion with Nycomed, allowing it to launch under a licensing agreement in September 2012.
Cutivate is used to treat dermatitis in patients ages one year and older and had sales of approximately $50 million during the 12-month period that ended in February, according to Wolters Kluwer. (DrugStoreNews 5/12/11)
Industry News - May 6, 2011
Potential Upcoming Generic Launches
Carbatrol: Potential exclusive launch by Teva by the end of April.
Rhinocort AQ: Potential launch in July by Teva and Apotex, with Par as the authorized generic.
RECENT LAUNCHES
Watson launches generic Concerta
Watson Pharmaceuticals launched an authorized generic version of Concerta (methylphenidate hydrochloride extended-release tablets) as part of an exclusive agreement with Ortho-McNeil-Janssen Pharmaceuticals. Under the terms of the exclusive supply and distribution agreement, Ortho-McNeil-Janseen manufactures and supplies Watson with all dosage strengths of the authorized generic product. Watson markets and distributes the product in the United States. The agreement runs until the end of 2014. During the term of the agreement, Watson may continue to pursue FDA approval of its ANDA for a generic version of Concerta and may launch its own ANDA product at the conclusion of the exclusive supply agreement. Other terms of the agreement have not been disclosed. Concerta had brand sales of approximately $846M. (PRNewswire 5/2/11)
Cypress launches generic Elestat
Cypress Pharmaceutical announced it has launched Epinastine HCl Ophthalmic Solution, 0.05%, the AT-rated generic of Allergan's Elestat. As the first company to file an ANDA containing a paragraph IV certification for this product, Cypress has been awarded a 180-day period of marketing exclusivity.
Annual sales of Elestat were approximately $21 million. (PharmaLive 5/2/11)
INDUSTRY UPDATES
Teva to buy Cephalon for $6.8 billion
Teva announced that it signed a definitive agreement to acquire Cephalon in a deal valued at approximately $6.8 billion. Commenting on the transaction, Teva CEO Shlomo Yanai said "this is transforming for Teva's branded business, as it will help us to deliver on our strategic goal of creating a diversified, multi-faceted company," adding that "our significantly broader portfolio will permit marketing and sales synergies and enhance profitability." Teva pointed to Cephalon's experimental drug pipeline as a driving factor in making the deal, with the combined company holding more than 30 experimental products in at least mid-stage development. In addition, Cephalon has a small generics business that Teva indicated would complement its own presence in countries such as Switzerland. (FirstWord 5/2/11)
April 27, 2011
American Pharmacies Press Release: Humana-Walmart Prescription Drug Plan Locks Out Other Pharmacies
April 27, 2011
American Pharmacies Says Medicare Part D Laws Not Enforced
April 18, 2011
ALERT: CS/CS/HB 7095 is coming to the Florida House of Representatives Floor for vote on April 20, 2011!
April 11, 2011
NCPA Press Release: A new Florida study has found flaws with the Medicaid Managed Care Pilot Program
March 23, 2011
Bayer Health Care has released their new coupons and are available
March 13, 2011
PPSC announces its new partnership with Learnsomething, Inc. 
