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 a generic version of Glucotrol XL tablets 5 mg and 10 mg, prior to the expiration of patents owned by Alza Corporation.

Alza, together with Pfizer, Inc., the marketer of Glucotrol XL, filed suit against Watson on December 18, 2002 in the U.S. District Court of New Jersey, seeking to prevent Watson from commercializing the product. Alza and Pfizer's suit was filed under the provisions of the Hatch Waxman Act.

Glucotrol XL (glipizide extended release tablets) is indicated as an adjunct to diet for the control of hyperglycemia in patients with type-2 diabetes. Pfizer reported U.S. Glucotrol XL sales of approximately $265 million for the twelve months ending September 30, 2002.