Watson files for generic Femcon

California, USA-based specialty drugmaker Watson Pharmaceuticals has filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market a generic version of the oral contraceptive Femcon Fe (norethindrone and ethinyl estradiol tablets, chewable and ferrous fumarate tablets) tablets prior to the expiration of patents owned by Warner Chilcott.

Warner Chilcott filed suit against Watson on October 1, in the US District Court of New Jersey, seeking to prevent the latter from commercializing its product prior to the expiration of patent number 6,667,050. Warner Chilcott's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of FDA approval of Watson's ANDA for 30 months or until final resolution of the matter before the court, whichever occurs sooner.