Watson Pharmaceuticals files application for generic LYBREL

Mar 14 2008

Watson Pharmaceuticals, Inc. has confirmed that it 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 tablets, USP (0.09 mg/0.02 mg) extended-cycle oral contraceptive product prior to the expiration of patents owned by Wyeth.

Watson's Levonorgestrel and Ethinyl Estradiol product is a generic version of Wyeth's LYBREL(R) (levonorgestrel and ethinyl estradiol) tablets which is indicated for the prevention of pregnancy.

Wyeth filed suit against Watson on March 12, 2008 in the U.S. District Court, District of Delaware, seeking to prevent Watson from commercializing its product prior to the expiration of U.S. patent number 6,500,814. Wyeth's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, Watson believes it may be the first applicant to file an ANDA for LYBREL(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.