FDA application filed for generic version of OAB agent

Watson Pharmaceuticals, Inc. has filed an abbreviated new drug application with the FDA to market its darifenacin hydrobromide extended-release 7.5-mg and 15-mg product prior to the expiration of a patent owned by Novartis AG.

Watson’s darifenacin hydrobromide extended-release product is the generic version of Novartis AG’s Enablex, which is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Novartis AG filed suit against Watson on April 24, 2009, seeking to prevent Watson from commercializing its products prior to expiration of the Novartis patent. Watson said in a statement that 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 abbreviated new drug application for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner.