The generic buprenorphine and naloxone sublingual film, sold by Dr. Reddy’s Laboratories (NYSE:RDY) and Mylan (NSDQ:MYL), is designed to suppress withdrawal symptoms that crop in people addicted to opioids, as well as block the neurochemical effects of opioids.
“The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access,” FDA chief Dr. Scott Gottlieb said in prepared remarks.
“With opioid addiction becoming increasingly prevalent in America, the full approval and launch of our generic equivalent of Suboxone could not have come at a more critical time to help patients,” Dr. Reddy’s CEO Alok Sonig said in a statement. “We are excited to be launching this important product that will help enable patients to prevail over this insidious disease.”
Indivior was not pleased with Dr. Reddy’s announcement – the two companies are wrapped up in patent litigation that last ended with a court finding that Dr. Reddy’s product does not infringe upon Indivior’s Suboxone patents. Indivior said it is appealing that decision and that it will seek an immediate injunction to stop Dr. Reddy’s from launching the generic therapy.
“We are surprised by Dr. Reddy’s decision to launch ‘at risk’ given the ongoing litigation and associated significant risk to them of substantial economic damages if, as we believe, we eventually prevail in protecting the Suboxone Film patent estate,” Indivior CEO Shaun Thaxter said in a statement. “In the meantime, we will continue to pursue all legal avenues, including an immediate injunction until the legal status of our intellectual property is confirmed by the Courts.”