The product is indicated for the treatment of opioid dependence. The therapy should be used alongside counseling and psychosocial support for people living with opioid dependence, according to Mylan.
Sales for buprenorphine and naloxone sublingual films in the U.S. were roughly $1.87 billion in 2018, IQVIA reported.
The FDA approved the generic sublingual film, which is sold by Mylan and Dr. Reddy’s Laboratories (NYSE:RDY), in June last year. Since then, Teva Pharmaceuticals has also won FDA approval for a sublingual film designed to help treat opioid dependence.
The move to bring a generic sublingual film for opioid dependence to the market sparked a patent infringement suit from Indivior as the company tried to defend its billion-dollar product, Suboxone.
In November last year, the U.S. Court of Appeals for the Federal Circuit vacated a previous decision that stopped Dr. Reddy’s from selling its generic version of Indivior’s Suboxone. The court ruled that Indivior had not proven that it was likely to succeed on the merits of its patent infringement case.
At the time, Indivior said it planned to continue pursuing infringement claims against Dr. Reddy’s.