Watson files application for Enablex generic

CORONA, Calif. Watson Pharmaceuticals has filed a new drug application for an overactive bladder treatment.

The generic drug maker is seeking approval to market its version of Enablex (darifenacin hydrobromide) extended-release 7.5-mg and 15-mg product from the Food and Drug Administration, prior to the expiration of a patent owned by Novartis AG. Watson's product is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Novartis AG filed suit against Watson last week in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its products prior to expiration of U.S. patent number 6,106,864. Novartis AG's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner.

For the 12 months ended Dec. 31, 2008, Enablex had total U.S. sales of approximately $220 million, according to IMS Health data.