Avadel Pharma prevails in patent dispute with Jazz

Ireland-headquartered Avadel Pharmaceuticals (Nasdaq: AVDL) saw its shares gain more than 12% to $8.03 on Friday, after it announced a positive patent dispute ruling.

The US District Court for the District of Delaware ordered Jazz Pharmaceuticals (Nasdaq: JAZZ) to delist US Patent No 8731963 (the REMS Patent) from the US Food and Drug Administration’s (FDA) Orange Book. With this decision, Avadel seeks to accelerate the FDA’s final approval decision for Lumryz, a once-at-bedtime investigational formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.

“We are pleased with the court’s decision in favor of delisting the REMS Patent from the FDA’s Orange Book, potentially accelerating a final approval. Upon the delisting of the REMS Patent, we are prepared to work collaboratively with the FDA to move to a final approval decision for Lumryz,” said Greg Divis, Avadel’s chief executive, adding: “We are fully committed to bringing Lumryz to all eligible people with narcolepsy and look forward to providing updates on our progress.”