Bloomberg Law
Feb. 24, 2023, 6:24 PMUpdated: Feb. 24, 2023, 7:22 PM

Jazz Pharma Must Seek Xyrem Patent Delisting, Fed. Cir. Says (2)

Kelcee Griffis
Kelcee Griffis

Jazz Pharmaceuticals Inc. must reactivate a request that the US Food and Drug Administration remove a key patent for Xyrem, its twice-nightly narcolepsy drug, from its registry of approved drugs, the Federal Circuit ruled, a loss for the biopharmaceutical company in litigation challenging a rival treatment.

In a precedential opinion, the court on Friday revived a Nov. 18 injunction that forces Jazz to seek delisting of a controlled-substance distribution patent from the FDA’s Orange Book list of approved drugs.

The US Court of Appeals for the Federal Circuit panel agreed with a Delaware district court that Xyrem’s US Patent ...

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