Timing uncertain on introduction of generic Suboxone film

Two companies last week received Food and Drug Administration (FDA) approval to market generic versions of Suboxone sublingual film for treatment of opioid dependence. But ongoing patent litigation involving the marketer of the brand-name version of the drug complicates the question of when these generics might become available.

In a June 14 news release, FDA Commissioner Scott Gottlieb, MD, said the approvals are part of the agency's strategy to improve the quality of and access to treatments to combat opioid addiction. The release stated, “One of the ways the FDA is encouraging access and wider use of [medication-assisted treatment] is through the approval of generic versions of these products.”

Dr. Reddy's Laboratories SA and Mylan Technologies Inc., last week received federal approval to market generic buprenorphine-naloxone sublingual film. Dr. Reddy's already has announced plans to launch the drug in four dose strengths, while Mylan has not yet indicated how it will proceed.

Yet the situation is complicated by ongoing patent litigation involving Indivior, maker of the brand-name Suboxone film, which for years has been criticized for pursuing strategies to block generic competition for Suboxone (including during the time when the tablet form of the drug was most widely used. In the ongoing challenge to generic versions of film, Mylan had previously agreed to a settlement under which it was to hold off on introducing a generic until 2023, according to news reports.