Table of Contents
ALLEGAN, Mich. — Perrigo Co. has won a summary judgment in patent litigation for its planned generic version of Mucinex cough/cold medicine.
The company said Thursday that the United States District Court for the Western District of Michigan ruled that Perrigo’s product, guaifenesin extended-release tablets (600 mg), didn’t infringe on the medication’s patent.
Perrigo was sued by Adams Respiratory Therapeutics Inc., a subsidiary of Reckitt Benckiser Group, the New Drug Application holder and patent owner for Mucinex.
The Food and Drug Administration had approved Perrigo’s Mucinex generic in late 2011.
Plans call for Perrigo to launch its product within 90 days. The company has said that the new product will be packaged under store brands and proprietary brands.
An expectorant designed to relieve chest congestion and make coughs more productive, Mucinex had sales of about $146 million through food, drug and mass merchandisers for the last 12 months, according to data from SymphonyIRI Group cited by Perrigo.
"This is another example of Perrigo’s significant investment and commitment to bringing new store-brand products to the market," Perrigo chairman and chief executive officer Joseph Papa said in a statement. "Perrigo saves consumers over $5 billion annually and continually strives to make quality health care more affordable."
Also looking to roll out a Mucinex generic following successful patent litigation is Watson Pharmaceuticals Inc.
In July, the U.S. Court of Appeals for the Federal Circuit ruled that Watson’s planned generics of Mucinex (guaifenesin), Mucinex D (pseudoephedrine and guaifenesin) and Mucinex DM (dextromethorphan HBr and guaifenesin) extended-release products don’t infringe on the patent held by Reckitt Benckiser, which sued Watson in 2009. The decision upheld an earlier ruling in Watson’s favor in U.S. District Court in Florida.
Watson is continuing to seek final FDA approval of its generic Mucinex products.
