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Blocked By Sublocade: Braeburn Sues To Get Brixadi Buprenorphine Formulation Onto Market

 
• By Sue Sutter

Lawsuit against US FDA challenges scope of three-year exclusivity awarded to Indivior’s Sublocade, the first monthly depot formulation of buprenorphine for treating opioid use disorder.

Road Closed

Braeburn Pharmaceuticals Inc. is challenging the breadth of three-year marketing exclusivity awarded to Indivior PLC’s Sublocade (buprenorphine extended-release), which is blocking its Brixadi buprenorphine depot injection from coming to market in the US.

In a lawsuit filed against the US Food and Drug Administration April 9, Braeburn said the exclusivity awarded to Sublocade “extends beyond the scope of its approval and the patient population in which it was solely studied,” effectively denying access to any long-acting injectable

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