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# Court Orders FDA Reconsideration of Brixadi Application
- URL: https://www.fdaweb.com/court-orders-fda-reconsideration-of-brixadi-application/
- Published: 2019-07-23T12:00:00.000Z
- Updated: 2026-09-15T01:39:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144592

The DC federal court has vacated an FDA 12/2018 exclusivity determination that blocked Braeburn’s Brixadi (buprenorphine) extended-release injection for treating opioid use disorder from final approval through 11/30/20 due to exclusivity granted to Indivior’s Sublocade. The court [told](https://ecf.dcd.uscourts.gov/cgi-bin/show%5Fpublic%5Fdoc?2019cv0982-50&ref=fdaweb.com) FDA to reconsider its decision “with deliberate speed.”

The court said that the agency determined Sublocade exclusivity in the broadest sense and failed to demonstrate how the drug’s exclusivity was consistent with agency previous decisions.

Separately, Braeburn [says](https://www.prnewswire.com/news-releases/us-district-court-orders-fda-to-reconsider-application-for-final-approval-of-brixadi-buprenorphine-extended-release-injection-for-the-treatment-of-opioid-use-disorder-300889406.html?ref=fdaweb.com) it continues to wait for an FDA decision on its citizen petition asking that the agency refuse to give orphan drug exclusivity to Sublocade on the basis that opioid use disorder is not a bona fide orphan disease with over two million Americans diagnosed.