Fed Circuit refusal paves way for Suboxone generics

Rivals of British pharmaceutical company  Indivior will soon be able to sell generic versions of opioid addiction treatment Suboxone film (buprenorphine and naloxone) following a ruling of the US Court of Appeals for the Federal Circuit.

LSIPR  reported last November that the appeals court had vacated a preliminary injunction granted to Indivior against Indian generics maker  Dr Reddy’s Pharmaceuticals.

In the order issued yesterday, February 4, the Federal Circuit denied a petition from Indivior for a panel rehearing en banc in the case.

It is the latest decision in a long-running dispute between Indivior and Dr Reddy’s in which Indivior also accuses the Indian company of infringing its patent.

Following the earlier Federal Circuit ruling to vacate the injunction, Indivior claimed that allowing generic Suboxone products onto the market would most likely result in “a rapid and material loss of market share” for the company.

At the time, Indivior  predicted its loss of market share for the drug could be up to 80% “within a matter of months” of generic versions of the drug being released. Dr Reddy’s will be able to market the generics in the US from when the Federal Circuit’s mandate takes effect on Monday, February 11.

Indivior has said that it will request that the Federal Circuit stay the mandate until the resolution of its appeal against the US District Court for the District of Delaware’s finding that Dr Reddy’s did not infringe Indivior’s Suboxone patent (US number 8,603,514).

In the statement, Indivior also indicated that it will issue a petition for certiorari to the US Supreme Court in response to the latest Federal Circuit decision.

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