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

Executive Summary

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 Revokes Orphan Drug Designation For Indivior’s Sublocade

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.

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

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.

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

Braeburn Pharmaceuticals says awarding Indivior’s opioid use disorder treatment Sublocade seven-year orphan exclusivity that flows from a 1994 orphan drug designation for Subutex would be an abuse of the system. The US FDA said it is carefully considering whether Sublocade qualifies for exclusivity ‘within the context of the opioid public health emergency.’

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