US Pharm. 2010;35(2):36.
Watson Laboratories, Inc., filed an ANDA with the FDA seeking approval to market its levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg) oral contraceptive product prior to the expiration of Duramed Pharmaceuticals’ patent on the drug. Watson’s levonorgestrel and ethinyl estradiol product is a generic version of Teva’s LoSeasonique.
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 seeking to prevent the company from commercializing its product prior to the expiration of its patent.