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US FDA Revokes Orphan Drug Designation For Indivior’s Sublocade

Executive Summary

In first-of-its-kind decision, agency concludes it relied on unreasonable assumptions regarding total market size, and failed to consider information about other dosage formulations, in granting designation for buprenorphine under the cost recovery provision; however, the FDA reaffirms that scope of Sublocade’s three-year exclusivity will keep Braeburn’s Brixadi off the market for another year.

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US FDA Must Explain How It Defines ‘Innovation’ In Awarding Hatch/Waxman Exclusivity, Court Says

Agency's decision that Indivior’s Sublocade blocked Braeburn’s long-acting buprenorphine formulation Brixadi lacked ‘substantive guideposts’ in how innovation is defined for purposes of deciding scope of three-year exclusivity, US judge says.

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US FDA’s Transfer Policy For Orphan Drug Designation Under Scrutiny

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