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28 September 2017Americas

Indivior settles generic dispute with Mylan

UK-based Indivior, a company that specialises in addiction treatment drugs, has settled a dispute with generic manufacturer Mylan.

The deal resolves patent litigation related to Indivior’s Suboxone (buprenorphine and naloxone) Film, a drug to treat opioid addiction.

On September 14, Indivior sued Mylan at the US District Court for the Northern District of West Virginia.

The dispute stemmed from an Abbreviated New Drug Application (ANDA) filed by Mylan seeking approval to market a generic version of Suboxone.

US patent number 9,687,454, called “Sublingual and buccal film compositions”, was at the centre of the dispute.

The terms of the settlement are confidential and, as required by law, the parties will submit the agreement to the US Federal Trade Commission and the US 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 IP.”

“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.”

Earlier this month, LSIPR reported that Indivior intended to launch an appeal against a US District Court for the District of Delaware verdict that could lead to rival companies selling a generic version of Suboxone.

The ruling found Indivior’s US patent numbers 8,017,150 (“Polyethylene oxide-based films”); 8,603,514 (“Uniform films”); and 8,900,497 (“Process for making a film”) valid, but that generic products proposed by Dr Reddy’s, Watson (Actavis) and Par do not infringe them.

Although Indivior is unsure how much financial damage a generic alternative would do to the company in the long term, Suboxone accounted for 80% of Indivior’s US revenue for the year ending December 2016.

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More on this story

Americas
4 September 2017   Indivior, which specialises in addiction treatment drugs, intends to launch an appeal against a US District Court for the District of Delaware verdict that could lead to rival companies selling a generic version of its Suboxone Film, a drug to treat opioid addiction.
Americas
26 March 2018   UK-based Indivior has pledged to appeal a US court decision that found a drug developed by generics maker Alvogen doesn’t infringe three of Indivior’s patents.

More on this story

Americas
4 September 2017   Indivior, which specialises in addiction treatment drugs, intends to launch an appeal against a US District Court for the District of Delaware verdict that could lead to rival companies selling a generic version of its Suboxone Film, a drug to treat opioid addiction.
Americas
26 March 2018   UK-based Indivior has pledged to appeal a US court decision that found a drug developed by generics maker Alvogen doesn’t infringe three of Indivior’s patents.