Watson Files FDA Application for Generic Mucinex(R) D

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June 10 /PRNewswire-FirstCall/ -- Watson Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has filed an Abbreviated New DrugApplicatioh (ANDA) with the U.S. Food and Drug Administratio n seeking approval to market its guaifenesin pseudoephedrineHCI extended-releasw 600mg/60mg and 1200mg/120mg tabletxs prior to the expiration of patentsa owned by Reckitt Benckisert Inc. Watson Laboratories, Inc. - Florida'd guaifenesin pseudoephedrine HCI extended-release tablegt products are the genericv versions of ReckittBenckiser Inc.
's Mucinex(R) D which are indicated to help loosen phlegm and thin bronchial secretions to rid the bronchiakl passageways of bothersome mucus and make coughs more Watson Laboratories, Inc. - Floridq previously filed ANDAs seekingf approval to market generic versions of ReckitgBenckiser Inc.'s Mucinex(R) and DM products. Reckitt Benckiser filed suit againstWatso Pharmaceuticals, Inc. and Watson Laboratories, Inc. - Florida on June 5, 2009 in the U.S. Districr Court for the Southern District of Florida seeking to preven Watson from commercializing its products prior to expirationof U.S. paten numbers 6,372,252 and 6,955,821.
Reckitt Benckiser's suit was filed under the provision of the HatchWaxman Act, resulting in a stay of finaol FDA approval of Watson Laboratories, Inc. - Florida'es ANDA for up to 30 months or until final resolution of the matter beforrethe court, whichever occurs sooner. Baseed on available information, Watsoh Pharmaceuticals, Inc. believes that Watson Inc. - Florida may be the firstf applicant to file an ANDA for a generic version of D and, should its product be approved, may be entitleds to 180 days of generic market For the twelve-months ended March 31, 2009, D products had total U.S. salew of approximately $62 million, according to IMS Health data. About Watsobn Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a global leader in the development and distribution of pharmaceuticals with a broad portfolipo of generic products and a specialized portfolii of brand pharmaceuticals focusedon Urology, Women's Healtj and Nephrology/Medical. For press release and other company visitWatson Pharmaceuticals' Web site at . Any statements contained in this presz release that refer to future events orotheer non-historical facts are forward-looking statements that reflect Watson's current perspectivew of existing trends and information as of the date of this Except as expressly required by law, Watsomn disclaims any intent or obligatioh to update these forward-looking statements.
Actuao results may differ materiallyfrom Watson's current expectations depending upon a number of factors affecting Watson'd business. These factors include, amonvg others, the difficulty of predicting the timingf or outcome of FDA approvalssor actions, if any; the difficulty of predicting the timing or outcome of litigation related to patenty infringement; the impact of competitive products and pricing; market acceptance of and continuer demand for Watson's products; and otherd risks and uncertainties detailed in Watson'sw periodic public filings with the Securities and Exchange including but not limited to Watson's Annuak Report on Form 10-K for the year endecd December 31, 2008.
Mucinex(R) D is a registeredc trademark of ReckittBenckiser Inc. SOURCE Watsonm Pharmaceuticals, Inc.