Indivior Settles Patent Dispute with Mylan

UK-based specialty pharmaceuticals company Indivior, formerly part of Reckitt Benckiser, has reached an-out of-court settlement with Mylan Pharmaceuticals, which was planning to launch a generic version of Indivior’s heroin addiction treatment, Suboxone Sublingual Film.

Litigation has been pending in the US after Mylan filed an application to the Food & Drug Administration (FDA) for approval to market a generic version of Suboxone.

Details of the agreement with Mylan, which has been made by Indivior’s US subsidiary along with Monosol Rx, are being kept confidential. The parties will now submit the proposed settlement to the US Federal Trade Commission and the 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.”

As well as Mylan, Indivior also filed lawsuits on Sept. 15 in a Delaware court against Actavis, Par Pharmaceutical, Alvogen, Teva Pharmaceutial Industries and Dr. Reddy’s Laboratories, for infringing its Suboxone ‘454 patent in their respective proposed generic alternatives.

The court had previously ruled on Sept. 1 that Dr. Reddy’s Laboratories had not infringed three other Suboxone patents, paving the way for the Indian generics firm to seek FDA approval for its copy-cat version. Indivior said it will appeal the verdict.

The UK pharma won a separate US court battle in June against Actavis and Par Pharmaceutical over its ‘514 Suboxone Film patent.

The UK group believes that the launch of a generic film alternative in the US could potentially result in a “rapid and material loss of market share within months”. In 2016, the average market share in the US for Suboxone Film was 61% with sales representing about 80% of Indivior’s annual revenue.

Suboxone is a dissolvable film that is placed under the tongue to trick the brain into thinking it is still receiving an opioid.