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Indivior settles with Par over delayed generic Suboxone
Indivior has reached a settlement to resolve patent litigation it had filed over its Suboxone treatment for opioid addiction against Par Pharmaceutical.
In 2016, a US district court ruled that Indivior's asserted claims of its US Patent No. 8,017,150, which is set to expire in 2023, were valid but not infringed by a generic equivalent for which Par had applied for regulatory permission, with a similar product also having been submitted by Watson Pharmaceutical's Actavis generic drug business.
The FTSE 250 company said on Monday that as part of its settlement, Par would be allowed to begin selling a generic version of Suboxone film from 1 January 2023.
"We continue to seek greater certainty for Indivior, but on terms that adequately reflect the strength of our intellectual property," said Indivior chief executive Shaun Thaxter, adding that three new Orange Book patents have been asserted against the remaining companies to have filed Abbreviated New Drug Application with the US regulator to make generic Suboxone.
The remaining three ANDA filers are Teva, Actavis and Dr Reddy's.