Indivior In Deal To Settle SUBOXONE Patent Infringement Case With Mylan

(RTTNews) - Specialty pharmaceutical company Indivior PLC (INDV.L) announced Monday that its U.S. subsidiary, Indivior Inc., together with Monosol Rx, LLC, entered into a settlement agreement with Mylan Pharmaceuticals Inc., Mylan Technologies Inc., and Mylan N.V. The deal is to resolve patent litigation related to SUBOXONE (buprenorphine and naloxone) Sublingual Film. The terms of the settlement are confidential.

The litigation has been pending in the U.S. District Court for the District of Delaware and resulted from Mylan's submission of an Abbreviated New Drug Application or ANDA to the U.S. Food & Drug Administration seeking approval to market generic versions of SUBOXONE Film.

As required by law, the parties will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.

Shaun Thaxter, CEO of Indivior, said, "We are pleased to have amicably settled all outstanding litigation with Mylan. 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."