BRIEF—Indivior in settlement with Par Pharma over Suboxone

UK-based Indivior and its US subsidiary have entered into a settlement agreement with Par Pharmaceutical and its affiliates resolving patent litigation related to Suboxone (buprenorphine and naloxone) Sublingual Film, which is used is used in the treatment of opioid addiction.

The litigation has been pending in the US District Court for the District of Delaware and resulted from Par's submission of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration seeking approval to market generic versions of Suboxone Film.

The settlement permits Par to begin selling a generic version of Suboxone Film on January 1, 2023, or earlier under certain circumstances. Other terms of the settlement are confidential.

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

Shaun Thaxter, chief executive of Indivior, said: "We are pleased to have amicably settled another piece of outstanding patent infringement litigation. We continue to seek greater certainty for Indivior, but on terms that adequately reflect the strength of our intellectual property, including the three new Orange Book patents that have been asserted against the remaining ANDA filers."