US-based Indivior has filed patent lawsuits against the generic rivals like Dr Reddy’s Laboratories, Actavis, Par, Alvogen, Teva and Mylan for an alleged infringement of patents relating to their respective proposed generic versions of Suboxone. The Suboxone sublingual film is indicated for the treatment of opioid dependence.
The lawsuits allege that these companies infringe the ‘454 patent’, which was issued on June 27, 2017, and is listed in the FDA’s Orange Book. “The ‘454 patent relates to an oral film containing buprenorphine and naloxone. Indivior has been involved in the patent infringement litigation involving other, earlier issued patents covering Suboxone film with these same companies relating to their proposed generic products,” the company said.
“With the actions taken today, we continue to vigorously assert and defend our intellectual property. We strongly believe that these companies with their proposed generic products infringe on our intellectual property and we are taking the appropriate actions to enforce our position. Toward that end, we are also preparing our appeal against the recent decision in the lawsuit against Dr Reddy’s (pending in the US District Court for the District of Delaware), and expect to file our appeal with the US Court of Appeals for the Federal Circuit shortly after the District Court judgment is entered,” Shaun Thaxter, CEO, Indivior, said.
Reckitt Benckiser developed Suboxone sublingual film using MonoSol Rx’s PharmFilm technology. In December 2014, Reckitt Benckiser de-merged its pharmaceuticals business as Indivior. The USFDA has approved Suboxone film in four strengths: 2 mg /0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg (buprenorphine/naloxone). Suboxone Film treats opioid addiction and has a brand size of $1.7 billion in the US, as per IMS Health data.
Indivior is a global specialty pharmaceutical company and has a strong pipeline of product candidates to address chronic conditions and co-occurring disorders of addiction, including alcohol use disorder and schizophrenia.