A day after the U.S. Supreme Court turned down a plea for stay filed by Indivior, pharma major Dr. Reddy’s Laboratories has re-launched in the U.S. its generic version of the British drugmaker’s opioid dependence treatment drug Suboxone.
The re-launch, announced by Dr. Reddy’s late on Wednesday, follows the Court of Appeals for the Federal Circuit (CAFC) vacating the District Court’s preliminary injunction that prohibited DRL from selling the generic.
Indivior had subsequently approached the Supreme Court seeking a stay on the CAFC ruling in the case related to one patent of Suboxone. A statement from Dr. Reddy’s said the Federal Circuit’s decision became effective Tuesday and the company had resumed shipping the product – Buprenorphine and Naloxone Sublingual Film– a therapeutic equivalent generic version of Suboxone.
The CAFC, the company said, had concluded that Indivior had not shown that it was likely to succeed on its claim that Dr. Reddy’s product infringed U.S. Patent No. 9,931,305.
“We are pleased with the decision of the appellate court in Dr. Reddy’s favour,” CEO of North America Generics Marc Kikuchi said.
Earlier in the day, Indivior said DRL was “no longer prevented from selling, offering to sell, or importing their generic buprenorphine/naloxone sublingual film products.”
For DRL, Suboxone is one of the drugs that could deliver a blockbuster impact on the revenues. A slice of that was evident when the firm sold the product briefly, before a U.S. court, in June last year, passed a temporary restraining order on the sale in response to a plea by Indivior in a patent case.