UK-based Indivior on Thursday said its US unit Indivior has filed lawsuits against Dr Reddy’s Laboratories, Actavis Generics, Par Pharmaceutical, Alvogen Pharmaceutical and Teva Pharmaceutical Industries for infringing on US patents for the company’s Suboxone sublingual film product. The company, which is in to speciality pharmaceuticals business, has filed lawsuits for infringement of US Patent No 9,855,221 relating to the proposed generic versions being made by Dr Reddy’s, Actavis, Par, Alvogen and Teva of Indivior’s Suboxone film product. However, Dr Reddy’s did not respond to this development. Suboxone Film treats opioid addiction and has a brand size of $1.7 billion in the US, as per IMS Health data. “The lawsuits allege that the aforementioned companies infringe the ‘221 patent, which was issued on January 2, 2018, and is listed in the FDA’s Orange Book. The ‘221 patent relates to certain polymer film compositions having a substantially uniform distribution of active drug,” the company said.
Indivior has been involved in patent infringement litigation involving other, earlier issued patents covering Suboxone film with the same companies relating to their proposed generic products. “We continue to partner with Aquestive Therapeutics to innovate and generate new intellectual property around Suboxone film. We believe this new patent is strong and we are asserting it in order to protect our intellectual property rights,” Indivior chief executive Shaun Thaxter said in a statement.
To recall a recent development for a different patent on the same drug, the United States District Court of Delaware had ruled in favour of Dr Reddy’s Laboratories for Suboxone, (buprenorphine and naloxone) sublingual film. Dr Reddy’s had bought Suboxone Film’s abbreviated new drug application (ANDA) from Teva Pharmaceuticals for $70 million in June 2016 with seven generic filers.
The key patent expires in April 2024. However, Indivior said that it would appeal against the US court ruling. “The United States District Court, for the District of Delaware, issued its judgment in favour of Dr. Reddy’s Laboratories, ruling that the proposed generic version of Suboxone (buprenorphine and naloxone) sublingual film does not infringe US Patent Nos. 8,017,150; 8,603,514 and 8,900,497 as asserted by Indivior,” Dr Reddy’s had said in a statement.