New Jersey-based Mutual Pharmaceutical and two other generic firms are suing brand manufacturer Reckitt Benckisser for breach of contract, alleging that RB reneged on a license agreement to provide generic supplies of its cold and flu medicine Mucinex for sale.

Mutual and fellow generics makers URL Pharma and United Research Laboratories filed their lawsuit Aug. 6 in a Pennsylvania state district court, arguing that RB’s failure to supply generic Mucinex (guaifenesin) as specified under a 2007 deal has cost Mutual tens of millions of dollars in lost sales.

The license agreement stems from a patent infringement suit in which original Mucinex owner Adams Respiratory promised to provide generic copies of the OTC drug to Mutual for sale once another generic entered the market, Mutual said. That license agreement was amended to ensure Mutual’s rights following the sale of Adams to RB, the complaint says.

Fellow drugmaker Perrigo entered the generic Mucinex market in March 2013, Mutual said. But when it provided RB with notice that it wanted to buy its own product for resale in October 2013, it was rebuffed, the company added.

RB continues to refuse to enter into a supply agreement to provide generic Mucinex, Mutual said. And the generics maker cannot get its supply anywhere else, it added, constrained by patented Mucinex production technologies still held by RB.

Perrigo is the only company currently listed on the Orange Book as marketing a generic Mucinex. Its unfettered access has allowed it to shore up its control of the market, the complaint said.

RB did not respond to a request for comment by press time. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.