Watson Pharmaceuticals, Inc. has confirmed that its subsidiary, Watson Laboratories, Inc.-Florida, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its trospium chloride extended-release 60 mg capsules prior to the expiration of a patent owned by Supernus Pharmaceuticals, Inc.
Watson's trospium chloride extended-release capsules are the generic version of Allergan Inc.'s Sanctura XR product, which is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
Allergan filed suit against Watson on July 13, 2009 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 7,410,978. Allergan'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.
Watson believes it may be first to file an ANDA for generic trospium extended-release capsules. For the twelve-months ended March 31, 2009, Sanctura XR had total U.S. sales of approximately $42 million, according to IMS Health data.