Axsome sets 2040 generic date in SUNOSI patent deal
Axsome Therapeutics has entered into a settlement agreement with Alkem Laboratories resolving U.S. patent litigation over Axsome’s wake‑promoting drug SUNOSI (solriamfetol).
Rhea-AI Filing Summary
Axsome Therapeutics has entered into a settlement agreement with Alkem Laboratories resolving U.S. patent litigation over Axsome’s wake‑promoting drug SUNOSI (solriamfetol). The case arose after Alkem filed an Abbreviated New Drug Application seeking approval to market a generic SUNOSI in the United States.
Under the settlement, Axsome will grant Alkem a license to sell its generic 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, in each case subject to FDA approval and customary conditions. The settlement will be submitted to the FTC and DoJ for review, and Axsome notes that similar patent litigation against another party regarding SUNOSI remains pending in the same court.
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Insights
Axsome locks in a distant generic entry date for SUNOSI, pending agency review.
The settlement with Alkem resolves one U.S. patent challenge to SUNOSI by fixing when Alkem can launch a generic, no earlier than March 1, 2040 or September 1, 2040 depending on pediatric exclusivity, subject to FDA approval and customary conditions.
This provides a clearer patent-protected timeline for this product with respect to Alkem but does not resolve Axsome’s similar litigation against another party, which remains pending in the District of New Jersey. The agreement must also be reviewed by the Federal Trade Commission and Department of Justice, as required by law.
Subsequent disclosures about the outcome of agency review and the remaining SUNOSI patent litigation in the District of New Jersey will shape how durable this protection is against other potential generic entrants.
8-K Event Classification
FAQ
What did Axsome Therapeutics (AXSM) announce about the SUNOSI patent litigation?
When can Alkem launch a generic version of SUNOSI under the Axsome (AXSM) settlement?
Is other SUNOSI patent litigation still ongoing for Axsome Therapeutics (AXSM)?
What regulatory reviews are required for the Axsome–Alkem SUNOSI settlement?
Which Axsome (AXSM) product is involved in the settlement with Alkem Laboratories?
Where is the SUNOSI patent litigation between Axsome (AXSM) and Alkem being heard?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On February 17, 2026, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcing that it has entered into a settlement agreement with Alkem Laboratories Ltd. (Alkem) resolving patent litigation related to Axsome’s product SUNOSI® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Alkem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic version of SUNOSI in the United States. Under the terms of the settlement agreement, Axsome will grant Alkem a license to sell its generic version 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. Similar patent litigation brought by Axsome against another party related to SUNOSI remains pending in the U.S. District Court for the District of New Jersey.
The settlement agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice. The description of the settlement agreement contained herein does not purport to be complete.
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.
(d) Exhibits
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Press Release dated February 17, 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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February 17, 2026 |
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/s/ Herriot Tabuteau, M.D. |
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Herriot Tabuteau, M.D. |
Exhibit 99.1
Axsome Therapeutics Settles SUNOSI® (solriamfetol) Patent Litigation with
Alkem Laboratories Ltd.
NEW YORK, February 17, 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 entered into a settlement agreement with Alkem Laboratories Ltd. (Alkem) resolving patent litigation related to Axsome’s product SUNOSI® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Alkem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic version of SUNOSI in the United States. Under the terms of the settlement agreement, Axsome will grant Alkem a license to sell its generic version 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.
As required by law, Axsome and Alkem will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Similar patent litigation brought by Axsome against another party related to SUNOSI remains pending in the U.S. District Court for the District of New Jersey.
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, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs 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.
Investors:
Ashley Dong
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Director, Investor Relations
(929) 687-1614
adong@axsome.com
Media:
Darren Opland
Director, Corporate Communications
(929) 837-1065
dopland@axsome.com
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