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news.Watson Pharmaceuticals has filed an abbreviated new drug application with the FDA seeking approval to market its levonorgestrel and ethinyl estradiol tablets 0.09mg/0.02mg, extended-cycle oral contraceptive product.
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Watson’s levonorgestrel and ethinyl estradiol product is a generic version of Wyeth’s Lybrel tablets which is indicated for the prevention of pregnancy.
Wyeth has filed suit against Watson on March 12, 2008 in the District Court of Delaware, seeking to prevent Watson from commercializing its product prior to the expiration of US patent. Wyeth’s suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson’s abbreviated new drug application (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 and, should its product be approved, may be entitled to 180 days of generic market exclusivity.