Legal Opinion
Braeburn Inc. v. U.S. Food & Drug Admin.
Court of Appeals for the D.C. Circuit
Decided July 22, 2019No. Civil Action No. 19-982 (BAH)PublishedCited by 6 opinions
1Opinion of the CourtBeryl A. Howell, Chief Judge
Both the plaintiff, Braeburn Inc., and the intervenor-defendant, Indivior Inc., are pharmaceutical companies that manufacture drug products using buprenorphine, a safer alternative to methadone, to treat moderate-to-severe opioid use disorder ("OUD"). All parties recognize the serious national public health problem posed by OUD and the need for effective treatment options for patients with this addiction. Braeburn's product, Brixadi, delivers buprenorphine through an injectable depot that releases buprenorphine over either a weekly or monthly period. In July 2017, Braeburn applied to the Food…
2Cases cited43 opinions
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3Cited by6 opinions
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