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2002 Rx-to-OTC switch approval for Mucinex caused all single-ingredient extended-release Rx guaifenesin products to be withdrawn (1"The Tan Sheet" Oct. 21, 2002, p. 5)...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.
The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.
Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.