Indivior plc said its US subsidiary Indivior Inc — together with Monosol Rx, LLC — entered into a settlement agreement with Mylan resolving patent litigation related to generic versions of Indivior’s opioid addiction treatment Suboxone.
Suboxone generates about 80% of Indivior’s revenue, according to Reuters data.
“The litigation has been pending in the US District Court for the District of Delaware and resulted from Mylan’s submission of an Abbreviated New Drug Application (ANDA) to the US Food & Drug Administration seeking approval to market generic versions of Suboxone Film,” said Indivior.
The 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.
Indivior CEO Shaun Thaxter 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.”