Watson Pharmaceuticals has confirmed that its subsidiary, Watson Laboratories, has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its levonorgestrel and ethinyl estradiol (0.10mg/0.02mg) oral contraceptive product.
The company intends to start marketing its product prior to the expiration of US Patent No. 7615545, which is owned by Duramed Pharmaceuticals, a subsidiary of Teva Pharmaceuticals. Watson’s levonorgestrel and ethinyl estradiol product is a generic version of Teva’s LoSeasonique. LoSeasonique is indicated for the prevention of pregnancy.
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 filed suit against Watson on January 6, 2010, in the US District Court for the District of New Jersey, seeking to prevent Watson from commercializing its product prior to the expiration of US Patent No. 7615545.
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.