MORRISTOWN, N.J., July 15 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.-Florida ("Watson"), 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((R))( )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((R)) had total U.S. sales of approximately $42 million, according to IMS Health data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of brand pharmaceuticals focused on Urology, Women's Health and Nephrology/Medical.
Watson's Forward-Looking Statement
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the difficulty of predicting the timing or outcome of litigation related to patent infringement; the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2008.
Sanctura XR((R)) is a registered trademark of Allergan, Inc.
|SOURCE Watson Pharmaceuticals, Inc.|
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