Dr Reddy’s Laboratories has entered into a settlement agreement with Indivior Inc, Indivior UK Limited and Aquestive Therapeutics to resolve all claims between the parties relating to the company’s generic buprenorphine and naloxone sublingual film. The settlement pact also included Indivior’s and Aquestive’s patent infringement allegations and the company’s antitrust counterclaims, the Hyderabad-based Dr Reddy’s informed the Bombay Stock Exchange on Friday. “Pursuant to the agreement, the company will receive payments totalling $72 million by March 31, 2024,’‘ Dr Reddy’s said adding that the underlying litigation would be dismissed as part of the settlement. Upon learning of DRL’s plans to launch the ANDA product “at risk,” in June 2018 Indivior moved to enjoin DRL from bringing its generic Suboxone film to market. In February 2019, Dr Reddy’s re-launched its Buprenorphine and Naloxone Sublingual Film, a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film, in the United States. The re-launch came on the heels of a favourable decision issued by the United States Court of Appeals for the Federal Circuit concluding that Indivior had not shown that it is likely to succeed on its claim that Dr Reddy’s product infringes US Patent No. 9,931,305. The Federal Circuit’s 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. Buprenorphine and naloxone sublingual film is generally indicated for treatment of opioid dependence.
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