REPORTERS Notebook

Supplier News

Greenstone announced the launch of an authorized generic version of the Alzheimer’s disease drug Aricept (donepezil hydrochloride) under an agreement with Eisai. Eisai makes the drug under a partnership with Pfizer.

Unlike generic drugs, which are approved under an abbreviated regulatory approval process by the Food and Drug Administration after the branded drug company’s market exclusivity has expired and compete with their branded counterparts, authorized generics are branded drugs sold under their generic names with permission from the branded drug maker, often through third-party companies.

The Food and Drug Administration has approved a generic drug made by Actavis for treating attention deficit hyperactivity disorder, Actavis said.

The FDA approved the drug maker’s atomoxetine hydrochloride capsules in the 10-mg, 18-mg, 25-mg, 40-mg, 60-mg, 80-mg and 100-mg strengths. The drug is a generic version of Eli Lilly’s Strattera, which had $532 million in sales during the 12-month period ended in June, according to IMS Health.

Actavis has not yet set a launch date for the drug, as the U.S. Court of Appeals for the Federal Circuit is reviewing an Aug. 12 ruling that invalidated Lilly’s patent on the drug, which will expire in 2017. India-based Sun Pharmaceutical Industries also received approval for its Strattera generic.

Actavis also announced in June the appointment of former Ratiopharm leader Claudio Albrecht as CEO. Albrecht has worked in the generic drug industry for more than 20 years, having started with Sandoz in 1987. He began working for Ratiopharm in 2000 as global CEO and established pharmaceutical consultancy Cometh in 2008.

Generic drug maker Mylan has managed to snag Bioniche Pharma Holdings sooner than expected, the company said. Mylan had announced its plans to buy Bioniche for $550 million in July.

Bioniche manufactures injectable pharmaceuticals, and Mylan said the acquisition would give it immediate entry into the North American market for injectables. It also announced the creation of Mylan Institutional, tailored to such healthcare institutions as hospitals, prisons, home infusion service companies and specialty pharmacies, combining Bioniche’s product line with that of UDL Labs, Mylan’s unit-dose business.

“Mylan Institutional will include, among other offerings, Bioniche Pharma’s diverse portfolio of products across several therapeutic areas for the hospital setting, including analgesics [and] anesthetics, orthopedics, oncology and urology,” Mylan president Heather Bresch said.

Generic drug maker Watson Pharmaceuticals has applied for Food and Drug Administration approval for a version of a drug used to treat eye diseases, Watson said.

Watson announced that subsidiary Watson Labs had filed for approval of brimonidine tartrate and timolol maleate ophthalmic solution in the 0.2%/0.5% strength. The drug is a generic version of Allergan’s Combigan, used to reduce pressure inside the eye, also known as intraocular pressure, in patients with glaucoma or ocular hypertension for whom current or previous therapies are ineffective.

The drug had sales of around $98 million during the 12-month period ended in July, according to IMS Health.

Allergan filed a patent infringement suit against Watson earlier this month in the U.S. District Court for the Eastern District of Texas in order to prevent Watson from marketing its version of the drug before the expiration of four patents covering Combigan, the last of which expires in January 2023, according to FDA records; the exclusivity period for the drug expires at the end of October of this year. Under the Hatch-Waxman Act, Allergan’s lawsuit places a stay on final FDA approval of Watson’s drug for 2.5 years, or until the two companies resolve the matter before the court.

Teva Pharmaceuticals has launched a generic treatment for epileptic seizures.

The world’s largest generic drug maker announced the launch of diazepam rectal gel, a generic version of Valeant Pharmaceuticals’ Diastat AcuDial. The drug is administered via rectal syringe and is available in 2.5-mg, 10-mg and 20-mg strengths.

“Generic pharmaceuticals are playing an increasingly important role in healthcare cost containment,” Teva VP customer operations and marketing Maureen Cavanaugh said. “Teva Pharmaceuticals continues to lead the way with timely new product launches.”

A generic drug maker has filed an abbreviated new drug application for its version of a Gilead Sciences drug. Sigmapharm is looking to receive regulatory approval from the Food and Drug Administration for generic Hepsera (adefovir dipivoxil). In a notice letter sent to Gilead, Sigmapharm alleged that two patents associated with Hepsera—U.S. Patent Numbers 5,663,159 and 6,451,340—owned by Gilead Sciences are invalid, unenforceable and/or will not be infringed by Sigmapharm’s manufacture, use or sale of the product described in its abbreviated new drug application submission.

Gilead currently is reviewing the notice letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Sigmapharm. Such a lawsuit would restrict the FDA from approving Hepsera’s ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first.

The Food and Drug Administration has approved a generic treatment for hypertension and liver cirrhosis made by Amneal Pharmaceuticals, Amneal said.

The FDA approved Amneal’s spironolactone hydrochloride tablets in the 25-mg, 50-mg and 100-mg strengths. The drug is a generic version of Pfizer’s Aldactone. Various versions of the drug had sales of $91 million in 2009, according to IMS Health.

The drug is used to treat high blood pressure, severe heart failure, cirrhosis of the liver, hyperaldosteronism and other diseases.

K-V Pharmaceutical is shipping its first product since it withdrew several products in 2008 and 2009 due to manufacturing problems, the drug maker said.

K-V said the Food and Drug Administration had given it approval to ship its Micro-K potassium chloride product following the completion of inspections of its manufacturing plant.

Ethex, K-V’s generic drug marketing and distribution division, pled guilty in February to two felony counts of failing to file alerts to inform regulators of manufacturing problems in 2008, and agreed to pay $27.6 million to the federal government to resolve the investigation. The settlement allowed K-V to continue manufacturing drugs once it had regained compliance with the FDA’s current good manufacturing practices regulations.

In March 2009, the FDA filed an injunction against K-V to prevent it from making or distributing adulterated and unapproved drugs, and forced the company to destroy the drugs it had recalled, forbidding it from resuming manufacturing until it had been brought back into compliance with regulations.

Efforts by two generic drug makers to market a generic version of a drug for multiple sclerosis hit an obstacle in a U.S. District Court.

The U.S. District Court for the Southern District of New York denied a motion for summary judgment filed by Sandoz and Momenta Pharmaceuticals that patents covering Teva Pharmaceutical Industries’ drug Copaxone (glatiramer acetate) are invalid due to indefiniteness.

“Teva is very pleased with today’s decision, which reaffirms our belief that the patents are valid and enforceable,” Teva corporate VP and chief legal officer Richard Egosi said. “We remain committed to vigorously defending Copaxone [intellectual property] rights against infringement wherever they are challenged.”

The court has yet to set a trial date. The patents covering Copaxone are set to expire in 2014, according to Food and Drug Administration records.

The Food and Drug Administration has approved Perrigo’s generic drug for treating skin diseases, the drug maker said.

The FDA approved Perrigo’s imiquimod cream in the 5% strength. The drug is a generic version of Graceway Pharmaceuticals’ Aldara.

The drug is used to treat actinic keratoses on the face and scalp, superficial basal cell carcinoma and external genital and perianal warts in patients ages 12 years and older.

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