Avadel Pharmaceuticals notched an FDA approval for narcolepsy drug Lumryz on Monday following a multi-year court battle with Jazz Pharmaceuticals.
Jazz was forced to delist its ‘963 patent, used for narcolepsy drug Xyrem, from the FDA’s Orange Book after a court decision in February, clearing the way for Avadel’s drug.
Jazz’s drug remains on the market, but Avadel is touting the once-nightly dosing for Lumryz, compared with Xyrem’s two doses taken at four-hour intervals during the night. Along with the approval, the FDA also granted Lumryz orphan drug exclusivity and a seven-year market exclusivity window beginning Monday. Lumryz is specifically approved to treat cataplexy, or excessive daytime sleepiness, in adults diagnosed with narcolepsy.
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