Warner Chilcott Files Suit Against Watson Laboratories Over Application For Generic Version Of Chewable Oral Contraceptive

Warner Chilcott has filed a federal lawsuit against Watson Laboratories in response to Watson's filing of an Abbreviated New Drug Application with FDA to market a generic version of Warner's chewable oral contraceptive Femcon Fe prior to the expiration of Warner's patent in 2019, Dow Jones reports (Derpinghaus, Dow Jones, 10/1). The lawsuit was filed in a U.S. District Court in New Jersey (Warner release, 10/1).

FDA in November 2003 approved the chewable version of Northern Ireland-based Galen Holdings' oral contraceptive Ovcon 35. The chewable pills, which Bristol-Myers Squibb manufactures, contain progestin and estrogen -- the same hormones used in standard birth control pills. Women will be able to chew the pills or swallow them whole; women who chew the pills must drink an eight-ounce glass of water afterward to ensure that the full dose reaches their stomachs. Femcon Fe has similar side effects to other birth control pills, such as an increased risk for blood clots, heart attack and stroke. One month's supply of the pill costs $44 wholesale.

Warner filed a lawsuit against Barr Laboratories in September for its FDA application for its generic version of Femcon Fe. Barr in April filed the FDA application to produce a generic version of the pill, and in August the company received notification of the application's acceptance for filing from the agency. Barr has said it is challenging Chilcott's patent for Femcon Fe, stating that it was the first to file an Abbreviated New Drug Application with FDA. FDA has placed a 30-month stay on action on Barr's application because of the suit (Kaiser Daily Women's Health Policy Report, 9/26). The agency also will place a 30-month stay on Watson's action in response to the lawsuit (Warner release, 10/1).

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