The U.S. Food and Drug Administration (FDA) has acknowledged its mistake in granting orphan drug status to Sublocade (injectable extended-release buprenorphine) two years ago amid criticism that the designation allowed the drug’s manufacturer, Indivior, to crowd out competitors.
In 1994, Subutex, an earlier sublingual version buprenorphine, received orphan status from the FDA even though opioid addiction is not considered a rare disease. Indivior based its application for Subutex on an Orphan Drug Act provision permitting orphan status when the manufacturer can prove that its drug is unlikely to be profitable and the company is unlikely to recover the cost of its development. After Subutex’s approval, however, Indivior went on to make billions of dollars in sales of the drug.
When Sublocade was approved in 2017, the FDA automatically granted orphan drug designation because it contained the same active ingredient as Subutex. Per the Orphan Drug Act provision, Indivior was not required to show whether the drug could recover its costs. In addition, Sublocade received seven years of marketing exclusivity, shielding the drug from competition until 2024.
In trying to take a competing opioid addiction treatment to market, Brixadi (extended-release injectable buprenorphine), Braeburn Pharmaceuticals sued the FDA and Indivior for this alleged deceit, and a court ruling required the agency to rescind Sublocade’s orphan drug status – allowing Braeburn to seek approval of its product. The FDA’s response to the citizen’s petition filed by Braeburn acknowledged that “[it was] unreasonable to conclude that there would be no cost recovery” from Sublocade sales.