Indivior announced that its U.S. subsidiary, Indivior Inc., has filed patent lawsuits against Dr. Reddy's, Actavis, Par, Alvogen and Teva for infringement of United States Patent No. 9,931,305 (the '305 patent) relating to their respective proposed generic versions of the company's SUBOXONE® (buprenorphine and naloxone) Sublingual Film product.
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. Indivior has been involved in patent infringement litigation involving other, earlier issued patents covering SUBOXONE® Film with these same companies relating to their proposed generic products.
"The '305 patent, along with the other new Orange Book patents that we secured (the '454 and '221 patents), demonstrates our commitment to innovate and generate new intellectual property for the SUBOXONE® Film,” Shaun Thaxter, CEO of Indivior, said. “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."