Barr Pharmaceuticals Challenges Warner Chilcott Patent By Filing Application For Generic Version Of Chewable Oral Contraceptive

Main Category: Sexual Health / STDs
Also Included In: Women's Health / Gynecology;  Pharma Industry / Biotech Industry
Article Date: 21 Aug 2007 - 9:00 PST

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Warner Chilcott on Wednesday announced it has received a notice from Barr Laboratories indicating that Barr has filed an abbreviated new drug application with FDA for a generic version of the chewable oral contraceptive Femcon Fe, Reuters reports (Tickoo, Reuters, 8/15). According to a Barr release, the company is challenging Chilcott's patent for Femcon Fe, stating that it was the first to file an Abbreviated New Drug Application with FDA (Barr release, 8/15).

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. The pills will be available in a 28-day regimen with 21 white tablets containing norethindrone and ethinyl estradiol, as well as seven green placebo pills that induce a menstrual period. 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 (Kaiser Daily Women's Health Policy Report, 4/17).

According to the release, Barr filed the application in April and received notification of the application's acceptance for filing this month from FDA (Barr release, 8/15). Chilcott said the drug is protected by a U.S. patent that expires in 2019 and that the company "continues to have full confidence in its intellectual property protecting Femcon Fe" (Reuters, 8/15). Chilcott said that it is reviewing the details of Barr's notice (Chilcott release, 8/15).

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