Watson challenges Lo Loestrin Fe patent
PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection of a contraceptive drug made by Warner Chilcott, Watson said Friday.
The company announced that it had filed a regulatory application with the Food and Drug Administration for norethindrone acetate and ethinyl estradiol tablets in the 1-mg/0.01-mg strength and ethinyl estradiol and ferrous fumarate tablets in the 0.01-mg/75-mg strength. The treatment is a generic version of Warner Chilcott’s Lo Loestrin Fe.
Warner Chilcott filed a patent infringement suit on Wednesday in the U.S. District Court for the District of New Jersey to prevent Watson from commercializing its product before the expiration of U.S. Patent Nos. 5,552,394 and 7,704,984, which will happen in July 2014 and February 2029, respectively, according to the FDA.
Under regulations governing generic drugs, the suit puts a stay of final FDA approval on Watson’s product for 30 months or until the companies settle the case.
FDA approves generic Parkinson’s disease drug made by Actavis
MORRISTOWN, N.J. — The Food and Drug Administration has approved a treatment for Parkinson’s disease made by Actavis, the drug maker said Friday.
Actavis, which last month signed a deal with Watson Pharmaceuticals to be acquired for $5.6 billion, announced the approval and launch of ropinirole extended-release tablets in the 2-mg, 4-mg, 6-mg, 8-mg and 12-mg strengths.
The drug is a generic version of GlaxoSmithKline’s Requip XL, which had sales of about $59.4 million in 2011, according to IMS Health.
Dr. Reddy’s launches generic version of Plavix
HYDERABAD, India — Generic drug maker Dr. Reddy’s Labs has launched a generic version of a drug used to prevent clotting of the blood.
Dr. Reddy’s announced Friday the launch of clopidogrel tablets in the 75-mg and 300-mg strengths. The drug is a generic version of Plavix, made by Bristol-Myers Squibb and Sanofi. As one of the first companies to submit a completed regulatory application for the 300 mg strength of the drug, Dr. Reddy’s received 180 days of market exclusivity for it.
Plavix had sales of $6.74 billion during the 12-month period ended in March, according to IMS Health.