In June 2018, two companies received approval from the United States Food and Drug Administration to market generic suboxone film for treating opiate addiction. However, ongoing patent litigation involving brand-name marketers of the drug ties up the release and complicates matters. One question a lot of people may have is whether or not suboxone doctors will prescribe it or not if it is our suboxone doctors will be first in line to offer it to patients if we feel it’s beneficial. News Release: On June 14, 2018, the Food and Drug Administration Commissioner Scott Gottlieb, MD, stated approvals are part of the agency’s strategy to improve the quality of and access to treatments for opiate addiction. The press release stated the following, “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.” At the time of the press release, Dr. Reddy’s Laboratories SA and Mylan Technologies, Inc., received federal approval to market generic suboxone lingual film. Dr. Reddy’s has already announced its plans to market the drug in four different strengths, while Mylan, on the other hand, hasn’t publicly stated how they plan to proceed.
Why is Generic Suboxone Film so Hard to Market?
Our suboxone doctors are always looking for the most up-to-date information about medication-assisted treatment because it translates to better and more effective patient care. The situation for approving generic suboxone film is complicated by patent litigation, which for a long time has been criticized for trying to block generic drug approval. In the challenge to gain approval for generic suboxone film, Mylan had previously agreed to a settlement under which the company was to hold off on introducing a generic until 2023.
What Does This Mean for Suboxone Doctors?
The approval of generic buprenorphine-naloxone sublingual film means treatment options for opiate addiction are improving. With the ability to offer opiate addiction sufferers a choice in treatment options, it means more people may seek treatment and may be able to get and remain clean. Our suboxone doctors are excited for any treatment improvements for opiate addiction because it means more effective patient care and better success rates.
