Indivior PLC (LON: INDV) Indivior announced on 5/15/18 that its U.S. subsidiary, Indivior Inc., together with Aquestive Therapeutics, Inc. (formerly known as Monosol Rx, LLC), entered into a settlement agreement with Par Pharmaceutical Inc., Par Pharmaceutical Companies Inc., Endo International PLC (collectively, "Par") and IntelGenx Technologies Corp., resolving patent litigation related to Suboxone (buprenorphine and naloxone) Sublingual Film. The litigation has been pending in the U.S. District Court for the District of Delaware and resulted from Par's submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food & 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.
Shaun Thaxter, CEO 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."
Indivior has been locked in legal battles with several companies over patent challenges to Suboxone patents. In March of 2018, Indivior lost a patent ruling to Alvogen over Suboxone. Indivior may appeal this ruling. The company is still pursuing lawsuits against pharmaceutical companies Teva, Actavis and Dr Reddy’s.
Indivior is also anticipating a bright future for its recently launched long-lasting treatment for opioid addiction, Sublocade. Indivior believes Sublocade has the potential to be a blockbuster drug with sales over $1bn.