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


Mucinex patent

This article was originally published in The Tan Sheet

Executive Summary

The U.S. Patent & Trademark Office (USPTO) has granted the request of an anonymous third party to reexamine Adams Respiratory Therapeutics' patent for the extended-release delivery technology in Mucinex. The tablets have a bi-layered design that provides immediate and extended guaifenesin release. The reexamination process could take up to three years, and during the interim the patent will remain in effect, Adams maintains. The patent extends through 2020, according to FDA's Orange Book. The 2002 Rx-to-OTC switch approval for Mucinex caused all single-ingredient extended-release Rx guaifenesin products to be withdrawn (1"The Tan Sheet" Oct. 21, 2002, p. 5)...

You may also be interested in...

Adams Hopeful For Mucinex Patent Despite Initial USPTO Decision

Adams Respiratory Therapeutics expects its most recent patent on Mucinex brand OTC cough/cold remedies to protect the product line's market exclusivity until 2020, despite a challenge to an earlier patent on the products

Adams Mucinex Approval Spurs FDA Crackdown On Guaifenesin Products

Unapproved, single-ingredient guaifenesin extended-release Rx products should no longer be marketed because there is now an approved OTC version, according to FDA

Pfizer Eyes EU Pegfilgrastim Roll-Out By 1 April As US Launch Is Confirmed

Pfizer will aim to have its biosimilar Neulasta (pegfilgrastim) product, Nyvepria, on the market in both the EU and US by the end of the current quarter, a company spokesperson has informed Generics Bulletin, following a successful US launch.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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