PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection of a contraceptive drug made by Warner Chilcott, Watson said Friday.
The company announced that it had filed a regulatory application with the Food and Drug Administration for norethindrone acetate and ethinyl estradiol tablets in the 1-mg/0.01-mg strength and ethinyl estradiol and ferrous fumarate tablets in the 0.01-mg/75-mg strength. The treatment is a generic version of Warner Chilcott's Lo Loestrin Fe.
Warner Chilcott filed a patent infringement suit on Wednesday in the U.S. District Court for the District of New Jersey to prevent Watson from commercializing its product before the expiration of U.S. Patent Nos. 5,552,394 and 7,704,984, which will happen in July 2014 and February 2029, respectively, according to the FDA.
Under regulations governing generic drugs, the suit puts a stay of final FDA approval on Watson's product for 30 months or until the companies settle the case.