Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

Did Sarepta Need To Tell Investors About Its Vyondys 53 Dispute Resolution Request?

Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.

Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning

Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.

Topics

UsernamePublicRestriction

Register

PS103027

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel