Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg) oral contraceptive product prior to the expiration of U.S. Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceutical Industries, Ltd. Watson's levonorgestrel and ethinyl estradiol product is a generic version of Teva's LoSeasonique®.
On November 23, 2009, pursuant to the Hatch-Waxman Act, Watson notified Duramed that its ANDA requesting approval from the FDA for a generic version of LoSeasonique® contained a paragraph IV certification asserting that the LoSeasonique(®) patent is invalid, unenforceable and/or not infringed. Teva Women's Health, Inc. filed suit against Watson on January 6, 2010 in the U.S. District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 7,615,545. Based on available information, Watson believes it may be entitled to 180 days of generic market exclusivity or shared exclusivity should its product receive approval.
LoSeasonique® is indicated for the prevention of pregnancy.
SOURCE Watson Pharmaceuticals, Inc.