Avadel Pharmaceuticals and Jazz Pharmaceuticals Reach Global Settlement

Core Insights - Avadel Pharmaceuticals has reached a global settlement with Jazz Pharmaceuticals, dismissing all litigation with prejudice, which provides clarity on Avadel's intellectual property and commercial rights [1][2][8] - The settlement includes a $90 million payment from Jazz to Avadel and a defined pathway for Avadel's product LUMRYZ to enter the market for idiopathic hypersomnia as early as March 1, 2028 [2][8] Settlement Details - Avadel will receive a perpetual worldwide license for any patents that could be asserted against LUMRYZ, and Jazz will waive its right to royalties on past sales of LUMRYZ through September 30, 2025 [8] - Starting October 1, 2025, Avadel will pay Jazz ongoing royalties of 3.85% of net sales of LUMRYZ in narcolepsy until February 18, 2036, with a potential reduction to 3.75% [8] - For future FDA-approved indications starting March 1, 2028, LUMRYZ will be subject to a 10% royalty on net sales until February 18, 2036, with a potential reduction to 9.5% [8] Product Information - LUMRYZ is an extended-release sodium oxybate medication approved by the FDA as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults and pediatric patients with narcolepsy [4][6] - The FDA granted LUMRYZ seven years of Orphan Drug Exclusivity due to its clinical superiority over existing treatments, allowing for a once-nightly dosing regimen [6][7]