Axsome Therapeutics Inc.
Axsome Therapeutics Settles SUNOSI Patent Litigation with Alkem Laboratories
Summary
On February 17, 2026, Axsome Therapeutics, Inc. announced a settlement agreement with Alkem Laboratories Ltd. to resolve patent litigation concerning Axsome's product SUNOSI (solriamfetol). The agreement stipulates that Alkem will be granted a license to sell a generic version of SUNOSI in the United States starting on or after September 1, 2040, contingent on pediatric exclusivity for SUNOSI, or on or after March 1, 2040 if no such exclusivity is granted, subject to FDA approval and standard conditions. The settlement is pending review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
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About Axsome Therapeutics Inc.
Axsome Therapeutics Inc. specializes in the development and commercialization of transformative therapies for central nervous system (CNS) disorders. The company's focus is on addressing unmet medical needs in the fields of depression, migraines, and agitation associated with Alzheimer's disease, among other CNS conditions. Axsome's robust pipeline includes both clinical and preclinical stage compounds, highlighting a commitment to innovation and efficacy. By utilizing novel mechanisms of action, their product candidates aim to offer significant advantages over existing treatments. Axsome Therapeutics plays a crucial role in the pharmaceutical and healthcare sectors, helping reshape treatment paradigms for complex and challenging CNS disorders. Through strategic collaborations and leveraging cutting-edge research methods, the company seeks to provide effective healthcare solutions and improve quality of life for patients globally. Established on a vision to impact lives positively, Axsome continues to advance its clinical programs and regulatory approvals, thereby reinforcing its position in the biotechnology industry.
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