In June 2018, two companies received Food and Drug Administration approval to manufacture generic sublingual suboxone for the treatment of opiate dependence. However, in spite of the approval for generic suboxone, ongoing patent litigation involving the brand-name marketer of the drug makes it hard to tell when the generic form of the drug may become available to the public. The goal of making generic suboxone is to make it affordable and more accessible to those desperately in need of it.
In a June 14th, news release, FDA Commissioner Dr. Scott Gottlieb said approvals are part of the strategy the agency has to improve the quality and access of treatments available to people with opiate addiction. The FDA release said,” 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 Laboratory SA and Mylan Technologies received federal approval to market generic sublingual suboxone film. Dr. Reddy’s has already announced plans to market the drug in four different strengths, but Mylan has not announced how it plans to move forward.
Complications for Generic Sublingual Suboxone Release
The current situation regarding the release of generic sublingual suboxone involving Indivor, maker of the brand-name suboxone film, has for years received criticism for pursuing legal action to block the generic production of suboxone. Improving access to prevention, treatment and recovery services including medication-assisted treatment is the focus of the FDA’s ongoing work to reduce opiate overdoses and death.
If you or someone you love has struggled with an addiction to opiates, having access to generic sublingual suboxone could mean the difference between life and death. Please contact our suboxone clinic today to discuss your addiction, find out if MAT is a good option for you and to finally get the treatment you need to become drug-free.