The patent infringement case filed by Indivior Inc, Indivior UK Limited and Aquestive Therapeutics Inc in connection with Dr Reddy’s Laboratories’ generic buprenorphine and naloxone sublingual film has been disclosed in the US following a settlement reached by all stakeholders.
“On June 28, the US Court dismissed all claims and counterclaims pending in the case with prejudice, pursuant to a joint stipulation of dismissal filed by the parties. The stipulation of dismissal was filed pursuant to a settlement agreement that the company entered into with Indivior and Aquestive,” Dr Reddy’s said in an intimation to BSE.
“The settlement and dismissal resolves all claims between the parties, including Indivior’s and Aquestive’s claims for patent infringement as well as the company’s antitrust counterclaim against Indivior,” it added.
On June 24, Hyderabad-based Dr Reddy’s announced a settlement agreement with Indivior Inc, Indivior UK Limited and Aquestive Therapeutics Inc to resolve all claims between the parties relating to the company’s generic buprenorphine and naloxone sublingual film.
As part of the agreement, Dr Reddy’s will receive payments totalling $72 million by March 31, 2024.
On learning about Dr Reddy’s plans to launch the ANDA (abbreviated new drug application) product “at risk” in June 2018, Indivior moved to enjoin the Hyderabad-based company from bringing its generic Suboxone film to market.
Buprenorphine and naloxone sublingual film are generally indicated for treatment of opioid dependence.