Axsome Therapeutics (AXSM) ends SUNOSI patent suits, sets 2040 generic entry
Rhea-AI Filing Summary
Axsome Therapeutics, Inc. has resolved all patent litigation related to its wake-promoting therapy SUNOSI (solriamfetol). The disputes stemmed from Abbreviated New Drug Applications filed by companies seeking to market generic versions of SUNOSI in the United States.
Under a settlement with the only remaining first-to-file generic applicant, Axsome will grant five companies the right to sell generic SUNOSI beginning on or after September 1, 2040 if pediatric exclusivity is granted, or on or after March 1, 2040 if pediatric exclusivity is not granted, in each case subject to U.S. Food and Drug Administration approval and customary conditions. Axsome states that no other SUNOSI patent litigation remains pending and will submit the settlement agreement to the Federal Trade Commission and the Department of Justice for review.
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Insights
Axsome locks in long-dated SUNOSI patent peace with defined generic entry.
Axsome has ended all U.S. patent litigation around SUNOSI by settling with the last remaining first-to-file generic challenger. The agreement grants five companies rights to sell generic SUNOSI, but only starting in 2040 under specified conditions.
The settlement sets two potential U.S. generic entry dates: March 1, 2040 if SUNOSI does not receive pediatric exclusivity, or September 1, 2040 if such exclusivity is granted, all subject to FDA approval and customary conditions. Axsome notes that no other SUNOSI patent litigation is pending.
The arrangement provides a clear timetable for when generic competition may begin, but the economic impact depends on SUNOSI’s performance and any future regulatory decisions on pediatric exclusivity. The settlement must also be submitted to the Federal Trade Commission and Department of Justice for review, as required by law.
8-K Event Classification
Key Figures
Key Terms
Abbreviated New Drug Applications regulatory
pediatric exclusivity regulatory
first-to-file generic applicant regulatory
Federal Trade Commission regulatory
central nervous system (CNS) disorders medical
forward-looking statements regulatory
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
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Item 8.01 Other Events.
On June 3, 2026, Axsome Therapeutics, Inc. (the “Company”) issued a press release entitled “Axsome Therapeutics Announces Settlement Resolving All SUNOSI® (solriamfetol) Patent Litigation.”
The full text of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
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Press Release dated June 3, 2026. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Axsome Therapeutics, Inc. |
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June 3, 2026 |
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/s/ Herriot Tabuteau, M.D. |
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Herriot Tabuteau, M.D. |
Exhibit 99.1
Axsome Therapeutics Announces Settlement Resolving All SUNOSI® (solriamfetol) Patent Litigation
NEW YORK, June 3, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has resolved all patent litigation related to Axsome’s product SUNOSI (solriamfetol). The litigations resulted from submission of Abbreviated New Drug Applications to the U.S. Food and Drug Administration by companies seeking approval to market a generic version of SUNOSI in the United States.
Axsome resolved all outstanding SUNOSI patent litigation upon entering into a settlement agreement with the only remaining first-to-file generic applicant with pending patent litigation related to Axsome’s product SUNOSI. As part of the resolution of these lawsuits, Axsome will grant five companies the right to sell generic versions of SUNOSI beginning on or after September 1, 2040, if pediatric exclusivity is granted for SUNOSI, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. No other patent litigation relating to SUNOSI remains pending.
As required by law, Axsome will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
About Axsome Therapeutics
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.
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Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
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Investors:
Ashley Dong
Senior Director, Investor Relations
(929) 687-1614
adong@axsome.com
Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
dopland@axsome.com
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