Watson Pharmaceuticals, Inc. has confirmed that its subsidiary, Watson Laboratories, Inc.-Florida has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its trospium chlorideextended-release 60 mg capsules prior to the expiration of a patent owned bySupernus Pharmaceuticals, Inc. Watson’s trospium chloride extended-releasecapsules are the generic version of Allergan Inc.’s Sanctura XR product,which is indicated for the treatment of overactive bladder (OAB) with symptomsof urge urinary incontinence, urgency and urinary frequency. Allergan filed suit against Watson on July 13, 2009 in the U.S. DistrictCourt for the District of Delaware seeking to prevent Watson fromcommercializing its products prior to expiration of U.S. patent number7,410,978. Allergan’s suit was filed under the provisions of the Hatch WaxmanAct, resulting in a stay of final FDA approval of Watson’s ANDA for up to 30months or until final resolution of the matter before the court, whicheveroccurs sooner. Watson believes it may be first to file an ANDA for generic trospiumextended-release capsules. For the twelve-months ended March 31, 2009,Sanctura XR had total U.S. sales of approximately $42 million, according toIMS Health data.
