Indivior PLC said its US subsidiary Indivior Inc has filed patent lawsuits against Dr Reddy’s, Actavis, Par, Alvogen and Teva for infringement of a US patent related to their respective proposed generic versions of the company’s Suboxone sublingual film product.
Indivior PLC, a global specialty pharmaceutical company, said its US subsidiary Indivior Inc has filed patent lawsuits against Dr Reddy’s, Actavis, Par, Alvogen and Teva for infringement of a US patent related to their respective proposed generic versions of the company’s Suboxone (buprenorphine and naloxone) sublingual film product. Suboxone Film treats opioid addiction and has a brand size of $1.7 billion in the US, according to IMS Health data. “These lawsuits allege that the aforementioned companies infringe the ‘305 patent, which was issued on April 3rd, and has been submitted for listing in the FDA’s Orange Book. The ‘305 patent claims film compositions having a substantially uniform distribution of active drug,”’ the company said. Indivior has been involved in patent infringement litigation involving earlier issued patents covering Suboxone film, with these same companies relating to their proposed generic products. In a statement, Shaun Thaxter, CEO, Indivior, said that the ‘305 patent, along with the other new Orange Book patents that they secured, demonstrates the commitment to innovate and generate new intellectual property for the Suboxone film. “As a follow-on to our ‘514 patent, we believe this new patent is strong and we are asserting it to protect our intellectual property rights,” Thaxter said. Earlier, the company, which is into the speciality pharmaceuticals business, had 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. 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. Dr Reddy’s had bought Suboxone Film’s abbreviated new drug application from Teva Pharmaceuticals for $70 million in June 2016 with seven generic filers. The key patent expires in April 2024.