Axsome Resolves Sunosi® Patent Dispute with Hikma

NEW YORK, March 05, 2025 — Axsome Therapeutics, Inc., a prominent figure in the biopharmaceutical industry focusing on central nervous system (CNS) disorders, has announced a significant development in its ongoing patent litigation. The company, listed on NASDAQ under the ticker AXSM, has reached a settlement with Hikma Pharmaceuticals USA, Inc., regarding legal disputes over Axsome's product, Sunosi® (solriamfetol). This settlement, currently overseen by the United States District Court for the District of New Jersey, stems from Hikma's filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administration. This application sought approval to produce a generic version of Sunosi for the U.S. market.

The settlement grants Hikma a license to introduce its generic Sunosi variant no earlier than March 1, 2040, unless pediatric exclusivity is granted, which would delay the date to September 1, 2040. This agreement is contingent upon the approval from the FDA and follows the typical conditions and exceptions associated with such settlements. Both Axsome and Hikma are required by law to submit this settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for evaluation. It is important to note that similar patent litigations initiated by Axsome against other entities concerning Sunosi are still active in the District Court of New Jersey.

Axsome Therapeutics is dedicated to advancing the treatment of CNS conditions through innovative research and development. The company is committed to addressing critical areas of unmet need in clinical care by developing unique products that focus on novel mechanisms of action. This approach aims to bring meaningful improvements to patient outcomes. Axsome boasts a leading neuroscience portfolio, which includes FDA-approved treatments for conditions such as major depressive disorder, excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea, and migraine. The company is also engaged in numerous late-stage development programs targeting a wide array of serious neurological and psychiatric disorders that affect over 150 million individuals in the United States.

Through its pioneering research and development efforts, Axsome strives to tackle some of the most pressing challenges in neuroscience, aiming to improve the quality of life for patients and their families. The company's mission is to transform the therapeutic landscape for CNS disorders, ensuring that patients can lead fulfilling lives despite their conditions.

By focusing on innovative therapies and maintaining a robust pipeline, Axsome Therapeutics is poised to continue its leadership in the biopharmaceutical industry, potentially bringing forward new treatment options that could greatly enhance patient care in the CNS domain. As it progresses, Axsome remains committed to its mission of delivering scientific breakthroughs that address critical gaps in healthcare, ultimately contributing to the well-being of millions affected by CNS disorders.