Generic alternatives to Suboxone have arrived

The floodgates are about to open—generic alternatives to the opiate addiction treatment medication Suboxone will now be available.

Reckitt Benckiser Pharmaceuticals reported this week that the Food and Drug Administration (FDA) denied its “Citizen’s Petition” request that the federal agency enforce stricter packaging standards for all buprenorphine products in order to keep them out of children’s hands.

In denying the request and stating that the evidence the pharmaceutical company furnished did not warrant changes in existing packaging guidelines, the FDA informed Reckitt Benckiser that two manufacturers have now received approval to market generic buprenorphine/naloxone tablets. One of those companies, Actavis, Inc., has already announced that it will begin shipping its buprenorphine product immediately.

According to news reports, the FDA also indicated in its response to Reckitt Benckiser that it had received reports of anti-competitive activity on the Suboxone maker’s part.

In its statement announcing the denial of its petition, Reckitt Benckiser said that as a result of the FDA’s action, the company will proceed with its plans to discontinue the U.S. sale of Suboxone tablets on March 18. The company has steered much of its Suboxone business in recent years to a sublingual film version of the drug.

Addiction Professional attempted to speak with a Reckitt Benckiser representative to discuss the expected impact of the latest actions, but press spokespeople for the company did not respond to our request prior to this posting.