UK-based drug-maker Indivior PLC Tuesday said the US Court of Appeals for the Federal Circuit has refused to rehear the ruling vacating the preliminary injunction granted against Dr Reddy's Laboratories on generic suboxone, a sublingual film. Indivior is in a legal battle against the launch of the copycat version of its opioid addiction treatment by competitors, including Dr Reddy's Laboratories, in the US market.
The US court had earlier ruled that Indivior had not shown that it was likely to succeed on the merits of its infringement case and vacated a preliminary injunction of a district court that had prohibited Dr Reddys from selling its generic version of suboxone (buprenorphine and naloxone). The US court had also stated its mandate is currently set to issue on February 11.
After the mandate issues, Dr Reddy's would no longer be prevented from selling, offering to sell, or importing its generic buprenorphine/naloxone. Indivior intends to file an emergency motion with the US court to stay issuance of the mandate.
"We are disappointed that the court has denied Indivior's motion for rehearing," its CEO Shaun Thaxter said. ''However, we will continue to vigorously pursue our infringement cases against Dr Reddy's to protect our suboxone sublingual film patent portfolio...,'' he added.
In June, the US Food and Drug Administration (USFDA) had 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. However, sales and commercialisation activities were halted as a result of a court-imposed temporary restraining order against Dr Reddys.
(With inputs from agencies.)