The Hyderabad based Dr Reddy’s Laboratories inked a settlement agreement with Indivior Inc., Indivior UK Limited and Aquestive Therapeutics.
This settlement was made in order to resolve all claims made by the parties relating to Dr Reddy’s generic buprenorphine and naloxone sublingual film.
The pact dealt with and resolved the patent infringement allegations made by Indivior and Aquestive against Dr Reddy and the company’s antitrust counterclaims.
Following the agreement, Dr Reddy will receive $72 million (over Rs 560 crore) by March 31, 2024, as was informed to the Bombay Stock Exchange. The agreement also holds that all underlying litigation will be dismissed. The company shares also rose by 0.29% on the BSE.
Upon learning of DRL’s plans to launch the ANDA (Abbreviated New Drug Application) in June 2018; Indivior moved to enjoin the company from launching the Suboxone film. However, in February 2019, DRL launched Buprenorphine and Naloxone Film in the USA which is a generic version of Suboxone film.
This re-launch was a after a favorable decision for DRL by the United States Court of Appeals for the Federal Circuit. The decision held that Indivior failed to succeed on its claims against Dr Reddy’s Laboratory that there was a patent infringement.
The decision vacated the preliminary injunction on Dr Reddy's selling of generic sublingual film.
The Buprenorphine and naloxone sublingual film is a treatment that is used to treat opioid dependence/ addiction. It is a film that is taken orally, by placing on the underside of the tongue and allowing it to dissolve.