Watson said that its guaifenesin and dextromethorphan HBr/guaifenesin extended-release tablet products are the generic versions of Reckitt Benckiser’s Mucinex and Mucinex DM products which are indicated to help loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Reckitt Benckiser filed suit against Watson recently in the US District Court for the Southern District of New York seeking to prevent Watson from commercializing its products prior to expiration of its US patents.
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 abbreviated new drug applications (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.