Watson Files FDA Applications for Generic Mucinex(R)
Wed, 04/22/2009 - 5:57am
Watson Pharmaceuticals,Inc., a specialty pharmaceutical company, has filed two Abbreviated New Drug Applications (ANDAs) with the FDA seeking approval to market its guaifenesinextended-release 600mg and 1200mg tablets and its dextromethorphanHBr/guaifenesin extended-release 30mg/600mg and 60mg/1200mg tablets prior tothe expiration of patents owned by Reckitt Benckiser Inc. Watson'sguaifenesin and dextromethorphan HBr/guaifenesin extended-release tabletproducts are the generic versions of Reckitt Benckiser Inc.'s Mucinex(R) andMucinex(R) DM products which are indicated to help loosen phlegm (mucus) andthin bronchial secretions to rid the bronchial passageways of bothersome mucusand 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 Watsonfrom commercializing its products prior to expiration of U.S. patent numbers6,372,252 and 6,955,821. Reckitt Benckiser's suit was filed under theprovisions of the Hatch Waxman Act, resulting in a stay of final FDA approvalof Watson's ANDAs for up to 30 months or until final resolution of the matterbefore the court, whichever occurs sooner. Based on available information,Watson believes it may be the first applicant to file an ANDA for a genericversion of Mucinex DM(R) and, should its product be approved, may be entitledto 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 millionrespectively, according to IMS Health data.