Indivior reaches settlement with Mylan over patent dispute

Indivior has ended a patent dispute with Mylan concerning its heroin addiction therapy Suboxone (buprenorphine and naloxone) sublingual film by agreeing to an undisclosed settlement with the company.

Suboxone is Indivior’s best-selling product, responsible for 90% of its total revenue. The company launched legal action on 15 September over patent infringement allegations against Actavis, Teva, Alvogen and Par after the US District Court for Delaware ruled two weeks before that a generic version of Suboxone developed by Dr Reddy’s did not breach its patents.

The development hit Indivior hard, wiping away £1 billion of its value. It is estimated that generic competition to Suboxone could threaten up to 80% of the drug’s market share, meaning its manufacturer could face big problems in the near future as rival treatments close in.

"We are pleased to have amicably settled all outstanding litigation with Mylan," commented Shaun Thaxter, CEO of Indivior. "The agreement at once reflects our desire to create further certainty for Indivior and underscores the strength of our intellectual property. Further, as recently demonstrated with our newly granted ‘454 patent, we expect to expand the intellectual property estate for Suboxone film and vigorously assert and defend it."

The two companies will now submit the settlement for review by the US Federal Trade Commission and the US Justice Department.