Watson seeks two FDA approvals for OTC drug

CORONA, Calif. Generic drug maker Watson Pharmaceuticals has filed two approval applications with the Food and Drug Administration for a generic version of an OTC drug for reducing mucus buildup.

Watson said it had filed the application for guaifenesin extended-release tablets in the 600-mg and 1.2-g strengths and dextromethorphan HBr and guaifenesin extended-release tablets in the 30-mg/600-mg and 60-mg/1.2-g strengths. The tablets are generic versions of Reckitt Benckiser’s Mucinex and Mucinex DR, respectively.

Watson is seeking approval to market the drugs prior to the expiration of Reckitt Benckiser’s patents, which will occur in April 2020. Reckitt Benckiser filed a lawsuit against Watson Monday in the U.S. District Court for the Southern District of New York to prevent the generic drug maker from marketing its product.

Under the Hatch-Waxman Act of 1984, Reckitt Benckiser’s lawsuit requires the FDA to delay approval of Watson’s generic product for 30 months or until resolution of the matter before the court.

Mucinex and Mucinex DR had sales of $106 million and $85 million respectively in 2008, according to IMS Health data.