Dr Reddy’s to appeal US Court’s decision on sale of generic Suboxone film

New Delhi: Pharma major Dr Reddy’s Laboratories on Saturday said it will appeal the decision of the US District Court of New Jersey regarding further sales and commercialisation of its Buprenorphine and Naloxone sublingual film in America.

“The company disagrees with the court’s decision, and will vigorously appeal it,” Dr Reddy’s said in a BSE filing.

The company intends to appeal the decision made by the US District Court of New Jersey in a preliminary injunction hearing with respect to further sales and commercialisation of its product in the US, it added.

The Hyderabad-based firm had announced the receipt of approval by one of its wholly owned subsidiaries from the US Food and Drug Administration (USFDA) on 15 June 2018, Dr Reddy’s said.

The approval was for the company’s Buprenorphine and Naloxone sublingual film in various strengths for the US market. It is the generic version of Indivior UK’s Suboxone sublingual film. The product is indicated for treatment of opioid dependence.