Generics

NEW YORK The federal government got a kick in the face Thursday as an appeals court ruled in favor of patent litigation settlements between branded and generic drug companies.

NEW YORK Efforts by two generic drug makers to market a generic version of a drug for multiple sclerosis hit an obstacle this week 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.

 

 

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

 

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.

 

AMITYVILLE, N.Y. Hi-Tech Pharmacal had $40.4 million in sales during its fiscal first quarter ended July 31, the generic drug maker said Thursday. The numbers amounted to a decrease of $3 million from the same period in 2009.

 

PEAPACK, N.J. The generics division of Pfizer will sell an authorized generic version of a drug used to treat dementia.

 

Greenstone said Wednesday that it had agreed with Eisai to launch donepezil hydrochloride tablets, an authorized generic of Aricept. The drug is used to treat dementia related to Alzheimer’s disease. Eisai makes the drug under a partnership with Pfizer.

 

 

MORRISTOWN, N.J. The Food and Drug Administration has approved a generic oral contraceptive made by Watson Pharmaceuticals, the drug maker said Tuesday.

 

Watson announced the FDA’s approval of Zarah (drospirenone and ethinyl estradiol tablets) in the 3 mg/0.03 mg strength. The drug is a generic version of Bayer’s Yasmin.

 

 

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

 

PEAPACK, N.J. The generics subsidiary of Pfizer is launching a new business focused on authorized generics.

 

Greenstone announced Tuesday the launch of the Authorized Generics Alliance, which it said would combine its business model and 17 years of experience in the generics market with the expertise of other drug makers to market authorized generics in the United States under the Greenstone label.