Watson files for generic Mucinex D
This article was originally published in The Tan Sheet
Executive Summary
The Corona, Calif.-based firm seeks to market generic extended-release guaifenesin pseudoephedrine HCl 600 mg/60 mg and 1200 mg/120 mg, equivalent to Reckitt Benckiser's Mucinex D and Maximum Strength Mucinex D expectorant and nasal decongestant. Watson said June 10 it appears to be the first to file an abbreviated new drug application for the product, meaning it would be entitled to 180 days of generic market exclusivity should it overcome Reckitt's patents. Reckitt filed suit against Watson June 5, as it did upon Watson's April filings to market generic Mucinex and Mucinex DM (1"The Tan Sheet" April 27, 2009, p. 10). Watson says Mucinex D products totaled about $62 million in U.S. sales for the 12 months ended March 31, based on IMS Health data
You may also be interested in...
Watson Files ANDA For Mucinex DM, Gets In Line For Generic Guaifenesin
Watson Pharmaceuticals appears to be the first firm to file an abbreviated new drug application with FDA to market a private label version of Reckitt Benckiser's Mucinex DM
Mustang Bio Enters Race For CAR-T In Autoimmune Disease
The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.
Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024
Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.