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The FDA has Approved a Generic Version of Suboxone

The FDA recently approved two generic versions of Suboxone, the sublingual form of buprenorphine combined with naloxone. These are the first generic versions of Suboxone the FDA has approved.

Suboxone is one of three medications commonly used to treat opioid addiction. The other two medications typically used in medication assisted treatment, or MAT, are methadone and naltrexone, often administered as the once monthly shot, Vivitrol. Suboxone is a combination of buprenorphine and naloxone. The naloxone component is typically inactive and is mainly included to prevent misuse by injection.

Like methadone, buprenorphine reduces the withdrawal symptoms of quitting opioids and reduces drug cravings. Buprenorphine, however, has the major advantage of being safer and less prone to abuse.

Despite this, methadone is currently more widely used. This is in part because methadone is much cheaper and available as a generic. A prescription of Suboxone currently costs between 130 and 470 dollars a month, depending on the dosage. A methadone prescription might cost a tenth of that. Although the price of the new generics is not known yet, they will likely make buprenorphine much more affordable for people paying out of pocket and for underfunded clinics.

Although the FDA has approved two versions of the sublingual films, it may take a while for them to reach the market. Invidior, the maker of Suboxone, attained a court order to prevent Dr. Reddy’s, one of the makers of the new generic, from developing and marketing the new product. Invidior is also involved with litigation against Mylan, maker of the other generic. No one knows how long the generics may be delayed getting to market, but in a previous settlement with Invidior, Mylan had agreed to delay the release of their generic until 2023.

The approval of these two drugs is part of the FDA’s efforts to address the current opioid crisis in the US by increasing the options for MAT and making medications more affordable. Their other efforts include promoting better prescribing practices, encouraging the development of better and less addictive pain treatment, and combating the illegal sale of opioids.

These new approvals should be seen as a good sign for people and families struggling with opioid addiction. In recent years, opioid treatment medications have been approved at an increasing rate. Notable new medications include Vivitrol, Sublocade–a once-monthly subdural form of buprenorphine–and now two generic versions of Suboxone. While no medication is perfect, more options–and especially more affordable options–allow for more people to get better treatment.

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