- Paragraph IV Litigation Underway -
CORONA, Calif., April 28 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval 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(R) 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 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 twelve-months ended December 31, 2008, Enablex(R) had total U.S. sales of approximately $220 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.
For press release and other company information, visit Watson Pharmaceuticals’ Web site at http://www.watson.com.
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.
Enablex(R) is a registered trademark of Novartis AG.
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CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611
Web site: http://www.watsonpharm.com/
