Court KOs REMS-related patent listing for Jazz narcolepsy drug
A Delaware district court said sayonara to a Jazz Pharmaceuticals patent related to the distribution system for its blockbuster narcolepsy drug Xyrem.
The case at hand involves Avadel CNS Pharmaceuticals, which sought to delist the patent in question, as it related to its restricted distribution system under its REMS.
After listing the patent in the Orange Book, Jazz filed a patent infringement lawsuit against Avadel, triggering a 30-month stay that blocks final FDA approval of Avadel’s competing (and tentatively approved) narcolepsy drug, a once-nightly formulation of sodium oxybate, which compares with the twice nightly Xyrem.
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