Watson Pharmaceuticals,Inc., a specialty pharmaceutical company, today confirmedthat its subsidiary, Watson Laboratories, Inc., has filed an Abbreviated NewDrug Application (ANDA) with the U.S. Food and Drug Administration (FDA)seeking approval to market its levonorgestrel and ethinyl estradiol (0.10mg/0.02 mg) oral contraceptive product prior to the expiration of U.S. PatentNo. 7,615,545, which is owned by Duramed Pharmaceuticals, Inc., a subsidiaryof Teva Pharmaceutical Industries, Ltd. Watson’s levonorgestrel and ethinylestradiol product is a generic version of Teva’s LoSeasonique. On November 23, 2009, pursuant to the Hatch-Waxman Act, Watson notifiedDuramed that its ANDA requesting approval from the FDA for a generic versionof LoSeasonique contained a paragraph IV certification asserting that theLoSeasonique patent is invalid, unenforceable and/or not infringed. TevaWomen’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 fromcommercializing its product prior to the expiration of U.S. Patent No.7,615,545. Based on available information, Watson believes it may be entitledto 180 days of generic market exclusivity or shared exclusivity should itsproduct receive approval. LoSeasonique is indicated for the prevention of pregnancy.
