Watson files application with FDA for generic YAZ

CORONA, Calif. Watson Pharmaceuticals is looking to produce a generic version of a popular oral contraceptive, the company said Wednesday.

The specialty pharma company has filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market a generic version of YAZ tablets (drosperinone and ethinyl estradiol) prior to the expiration of patents owned by Bayer.

Bayer filed suit against Watson on Monday in the U.S. District Court’s Nevada circuit, seeking to prevent Watson from commercializing its product prior to the expiration of patents.

Bayer’s suit was filed under the provisions of the Hatch Waxman Act, resulting in a postponement of FDA approval of Watson’s ANDA for 30 months or until final resolution of the matter before the court, whichever occurs sooner.

Sales of YAZ for 2006 were approximately $660 million, according to Bayer data.