AXSM Settles Sunosi Patent Litigation With Hikma Pharmaceuticals

Core Viewpoint - Axsome Therapeutics has reached a settlement with Hikma Pharmaceuticals regarding the patents for its narcolepsy drug, Sunosi, which allows Hikma to sell a generic version in the U.S. under certain conditions starting in 2040 [1][4]. Group 1: Settlement Agreement - The settlement resolves ongoing patent litigation initiated by Axsome against Hikma for filing an abbreviated new drug application for a generic version of Sunosi [1]. - Axsome will grant Hikma a license to market a generic version of Sunosi in the U.S. after March 1, 2040, or September 1, 2040, if pediatric exclusivity is granted [4]. - The settlement must be reviewed by the U.S. Federal Trade Commission and the U.S. Department of Justice [5]. Group 2: Product and Market Performance - Axsome acquired U.S. rights to Sunosi from Jazz Pharmaceuticals in May 2022 and began selling it in the U.S. market the same month, with international sales starting in November 2022 [2]. - Sunosi generated sales of $94.3 million in 2024, marking a 26% increase year-over-year [6]. - The drug is a significant revenue driver for Axsome and is currently being evaluated in phase III studies for ADHD, major depressive disorder, binge eating disorder, and excessive sleepiness associated with shift work disorder [7]. Group 3: Future Developments - Top-line data from studies evaluating Sunosi for ADHD and major depressive disorder are expected to be released in the first quarter of 2025 [8]. - Ongoing patent litigation related to Sunosi against other parties remains pending in the U.S. District Court for the District of New Jersey [5]. Group 4: Stock Performance - Over the past year, Axsome's shares have increased by 73.6%, contrasting with a 9.1% decline in the industry [3].