Watson Pharmaceuticals, Inc, a leading specialty pharmaceutical company, has filed two Abbreviated New Drug Applications (ANDAs) with the US 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 and Mucinex 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 US District Court for the Southern District of New York seeking to prevent Watson from commercializing its products prior to expiration of US 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 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 and Mucinex DM products had total US sales of approximately $106 million and $85 million respectively, according to IMS Health data.
Watson Pharma 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.