With US Supreme Court ruling in its favor, Indian pharma major Dr. Reddy’s Laboratories on Wednesday announced re-launch of a generic version of Suboxone, a sublingual film for opioid addiction treatment, in the US market.
Decks were cleared for the re-launch of Buprenorphine and Naloxone sublingual film after the US Supreme Court turned down UK pharma firm Indivior’s plea against the launch of a copycat version of its Suboxone by competitors.
The United States Court of Appeals for the Federal Circuit concluded that Indivior had not shown that it is likely to succeed on its claim that Dr. Reddy’s product infringes a US patent.
The decision vacates the District Court’s preliminary injunction that had prohibited Dr. Reddy’s from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film, the Hyderabad-headquartered company said in a statement.
As a result of the ruling, Dr. Reddy’s has resumed shipping of the product.
“We are pleased with the decision of the appellate court in Dr. Reddy’s favor, vacating the preliminary injunction that had prevented Dr. Reddy’s from continuing to market this important drug to the public,” said Marc Kikuchi, Chief Executive Officer, North America Generics.
“Dr. Reddy’s is committed to providing affordable treatment options for opioid use disorder and addiction. We look forward to helping patients and our communities in the United States who are impacted by the opioid epidemic,” he said.
In June 2018, the US Food and Drug Administration (USFDA) approved Dr. Reddy’s Buprenorphine and Naloxone Sublingual Film, in four strengths including 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, for sale in the US market. The product was launched immediately after approval, with sales and commercialization activities halted as a result of a court-imposed temporary restraining order (TRO) and preliminary injunction against Dr. Reddy’s.
The TRO and preliminary injunction did not prohibit commercial manufacturing of the product.