Watson files FDA application for generic LoSeasonique
MORRISTOWN, N.J. Watson Labs, a subsidiary of specialty pharmaceutical company Watson Pharmaceuticals, has filed an abbreviated new drug application to the Food and Drug Administration for an oral contraceptive.
Watson is 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, a subsidiary of Teva. Watson's levonorgestrel and ethinyl estradiol product is a generic version of Teva's LoSeasonique, which is indicated for the prevention of pregnancy.
On Nov. 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 Jan. 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.