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

Main Category: Litigation / Medical Malpractice
Also Included In: Pharma Industry / Biotech Industry;  Sexual Health / STDs
Article Date: 28 Sep 2007 - 4:00 PST

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Pharmaceutical company Warner Chilcott on Monday announced it has filed a lawsuit against Barr Laboratories in response to Barr's FDA application for a generic version of Warner's chewable oral contraceptive Femcon Fe, the AP/CNNMoney.com reports (AP/CNNMoney.com, 9/24). The suit was filed in New Jersey District Court (Warner Chilcott release, 9/24).

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.

Barr in April filed the FDA application to produce a generic version of the pill, and last month 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 (Kaiser Daily Women's Health Policy Report, 8/17). Warner said its patent on the drug does not expire until 2019. According to AP/CNNMoney.com, FDA will place a 30-month stay on action on Barr's application because of the suit (AP/CNNMoney.com, 9/24).

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