Court Weighs FDA’s Move to Break Jazz Orphan Drug Exclusivity

A federal judge presiding over whether the FDA broke Jazz Pharmaceutical’s orphan drug exclusivity for its sleep medicine focused his questions in a Friday hearing on when different products are considered the “same drug.”

Jazz Pharmaceuticals PLC sued the Food and Drug Administration for violating orphan drug exclusivity when the agency approved Avadel CNS Pharmaceuticals LLC’s Lumryz, a rival product of Jazz’s narcolepsy drug Xywav.

Judge Amit P. Mehta of the US District Court for the District of Columbia questioned the agency and Jazz over the FDA’s interpretation of “same drug” and whether it applies to Xywav and Lumryz.

The ...