Indivior to launch generic after SCOTUS refuses petition
Indivior has launched a generic version of its opioid addiction drug Suboxone (buprenorphine and naloxone) Film, one day after the US Supreme Court denied its request to put a lower court’s ruling on hold.
On Wednesday, February 20, UK-based Indivior said that its authorised generic version of Suboxone Film is being marketed and distributed in the US by Sandoz.
This follows a ruling by the US Court of Appeals for the Federal Circuit in early February, which vacated a preliminary injunction against India-based Dr Reddy’s and paved the way for generic versions of Indivior’s drug.
In its order, the Federal Circuit denied a petition from Indivior for a panel rehearing en banc in the long-running dispute between Indivior and Dr Reddy’s.
Back in June 2018, Indivior had secured a temporary restraining order against Dr Reddy’s from the US District Court for the District of New Jersey.
After a failed attempt to have the Federal Circuit stay its motion, Indivior filed a petition
to stay the mandate with the Supreme Court.
But, on Tuesday, February 19, the US’s highest court denied Indivior’s motion to stay issuance of the Federal Circuit’s mandate which vacated the preliminary injunction against Dr Reddy’s.
Indivior said in December last year that it might launch a generic version of Suboxone Film as part of a contingency plan to stem market share losses from generic rivals.
It previously predicted that 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.
The launch of the generic is expected to capture a share of the generic segment and generate net revenues in the tens of millions of dollars, according to the UK-based company.
Shaun Thaxter, CEO of Indivior, said: “We are making an authorised generic of our Suboxone Film brand product available to patients and providers immediately, giving them yet another option of medication-assisted treatment for opioid dependence.
“In addition, we expect this launch will create the opportunity to maximise the value of our Suboxone Film franchise.”
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