Indivior strikes deal to stave off Mylan generic
- British drugmaker Indivior plc revealed Monday it has resolved pending patent litigation with subsidiaries of generic drugmaker Mylan N.V.
- Indivior has been trying to fend off generic competition for its best-selling product, a film version of the opioid-dependence treatment Suboxone.
- Details of the outside settlement were not revealed, but will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. The lawsuit, filed in the U.S. District Court for the District of Delaware, was a result of Mylan filing an abbreviated New Drug Application with the Food and Drug Administration.
"We are pleased to have amicably settled all outstanding litigation with Mylan," said Indivior CEO Shaun Thaxter. "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," he added.
Indivior, which was split off of Reckitt Benckiser in 2014, has been going through a rough patch of late. Generic competition has been hitting its opioid-dependence meds hard, including Subutex (buprenophine) tablet and Suboxone (buprenorphine/naloxone) tablet.
The film version of Suboxone has been the company’s saving grace, making up as much as 80% of overall revenues at times.
But generic drugmakers — other than Mylan — are threatening that too. According to a filing with the Securities and Exchange Commission, rulings against both Actavis and Par Pharmaceuticals prevented each from launching a generic copy of the film. Both companiesd are expected to appeal. There is also pushback from Alvogen and Dr. Reddy’s Laboratories.
Indivior is also developing a subcutaneous injection for opioid dependence. The company is hoping to reduce treatment days from once daily to once monthly, making adherence for patients easier. The company notes in its financial statements that generic competition to its current franchise or a rejection from regulators could spell major problems for the business.
This development takes place against the backdrop of a growing opioid crisis in the U.S., which has seen the number of overdose deaths quadruple from 1999 to 2015, according to the Centers for Disease Control and Prevention.
- Indivior Press release
- BioPharma Dive Indivior stumbles as US states file antitrust suit
Follow Lisa LaMotta on Twitter