- Paragraph IV Litigation Underway -
CORONA, Calif., April 22 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, today confirmed that it has filed two Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration seeking approval to market its guaifenesin extended-release 600mg and 1200mg tablets and its dextromethorphan HBr/guaifenesin extended-release 30mg/600mg and 60mg/1200mg tablets prior to the expiration of patents owned by Reckitt Benckiser Inc. Watson’s guaifenesin and dextromethorphan HBr/guaifenesin extended-release tablet products are the generic versions of Reckitt Benckiser Inc.'s Mucinex(R) and Mucinex(R) DM products which are indicated to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Reckitt Benckiser filed suit against Watson on April 20, 2009 in the U.S. District Court for the Southern District of New York seeking to prevent Watson from commercializing its products prior to expiration of U.S. patent numbers 6,372,252 and 6,955,821. Reckitt Benckiser’s suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson’s ANDAs for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, Watson believes it may be the first applicant to file an ANDA for a generic version of Mucinex DM(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.
For the twelve-months ended December 31, 2008, Mucinex(R) and Mucinex(R) DM products had total U.S. sales of approximately $106 million and $85 million respectively, 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.
Mucinex(R) and Mucinex(R) DM are the registered trademarks of Reckitt Benckiser Inc.
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CONTACT: Patty Eisenhaur, Watson Pharmaceuticals, Inc., +1-951-493-5611
Web site: http://www.watsonpharm.com/
