Axsome Therapeutics Settles SUNOSI® (solriamfetol) Patent Litigation with Hetero Labs Ltd.
Axsome Therapeutics (NASDAQ: AXSM) has reached a settlement agreement with Hetero Labs Ltd. regarding patent litigation for its drug SUNOSI® (solriamfetol). The litigation arose from Hetero's submission of an Abbreviated New Drug Application seeking approval for a generic version of SUNOSI. Under the settlement terms, Axsome will grant Hetero a license to sell its generic version starting either September 1, 2040 (if pediatric exclusivity is granted) or March 1, 2040 (without pediatric exclusivity), subject to FDA approval. The agreement will be reviewed by the U.S. Federal Trade Commission and Department of Justice. Similar patent litigation with other parties remains pending.
Axsome Therapeutics (NASDAQ: AXSM) ha raggiunto un accordo di risoluzione con Hetero Labs Ltd. riguardo a una controversia brevettuale sul suo farmaco SUNOSI® (solriamfetol). La disputa è nata dalla presentazione da parte di Hetero di una Domanda Abbreviata di Nuovo Farmaco per ottenere l'approvazione di una versione generica di SUNOSI. Secondo i termini dell'accordo, Axsome concederà a Hetero una licenza per vendere la versione generica a partire dal 1° settembre 2040 (se verrà concessa l'esclusività pediatrica) oppure dal 1° marzo 2040 (in assenza di esclusività pediatrica), subordinatamente all'approvazione della FDA. L'accordo sarà sottoposto a revisione dalla Federal Trade Commission e dal Dipartimento di Giustizia degli Stati Uniti. Restano in corso contenziosi brevettuali simili con altre parti.
Axsome Therapeutics (NASDAQ: AXSM) ha llegado a un acuerdo con Hetero Labs Ltd. respecto a un litigio por patentes relacionado con su medicamento SUNOSI® (solriamfetol). La disputa surgió tras la presentación por parte de Hetero de una Solicitud Abreviada de Nuevo Medicamento para obtener la aprobación de una versión genérica de SUNOSI. Según los términos del acuerdo, Axsome otorgará a Hetero una licencia para vender su versión genérica a partir del 1 de septiembre de 2040 (si se concede la exclusividad pediátrica) o del 1 de marzo de 2040 (sin exclusividad pediátrica), sujeto a la aprobación de la FDA. El acuerdo será revisado por la Comisión Federal de Comercio y el Departamento de Justicia de EE.UU. Continúan pendientes litigios similares con otras partes.
Axsome Therapeutics (NASDAQ: AXSM)는 Hetero Labs Ltd.와 자사의 약물 SUNOSI® (solriamfetol) 특허 소송에 대해 합의에 도달했습니다. 이 소송은 Hetero가 SUNOSI의 제네릭 버전 승인을 위해 간소화 신약 신청서를 제출하면서 발생했습니다. 합의 조건에 따라 Axsome은 FDA 승인을 전제로, 소아 독점권이 부여될 경우 2040년 9월 1일부터, 소아 독점권이 없을 경우 2040년 3월 1일부터 Hetero가 제네릭 버전을 판매할 수 있는 라이선스를 부여합니다. 이 합의는 미국 연방거래위원회와 법무부의 검토를 받을 예정입니다. 다른 당사자들과의 유사한 특허 소송은 여전히 진행 중입니다.
Axsome Therapeutics (NASDAQ : AXSM) a conclu un accord de règlement avec Hetero Labs Ltd. concernant un litige relatif au brevet de son médicament SUNOSI® (solriamfetol). Ce litige est né de la soumission par Hetero d'une demande abrégée de nouveau médicament visant à obtenir l'approbation d'une version générique de SUNOSI. Selon les termes de l'accord, Axsome accordera à Hetero une licence pour vendre sa version générique à partir du 1er septembre 2040 (si l'exclusivité pédiatrique est accordée) ou du 1er mars 2040 (sans exclusivité pédiatrique), sous réserve de l'approbation de la FDA. L'accord sera examiné par la Federal Trade Commission et le Département de la Justice des États-Unis. Des litiges similaires avec d'autres parties sont toujours en cours.
Axsome Therapeutics (NASDAQ: AXSM) hat eine Vergleichsvereinbarung mit Hetero Labs Ltd. bezüglich eines Patentstreits über sein Medikament SUNOSI® (Solriamfetol) erzielt. Der Rechtsstreit entstand durch die Einreichung eines Abbreviated New Drug Application durch Hetero zur Zulassung einer Generikaversion von SUNOSI. Gemäß den Vergleichsbedingungen wird Axsome Hetero eine Lizenz erteilen, die Generikaversion ab dem 1. September 2040 (bei Gewährung der pädiatrischen Exklusivität) oder ab dem 1. März 2040 (ohne pädiatrische Exklusivität) zu verkaufen, vorbehaltlich der FDA-Zulassung. Die Vereinbarung wird von der US Federal Trade Commission und dem Justizministerium geprüft. Ähnliche Patentstreitigkeiten mit anderen Parteien sind weiterhin anhängig.
- Settlement protects SUNOSI's market exclusivity until at least March 2040
- Agreement provides clear timeline for generic entry, reducing uncertainty
- Potential for extended exclusivity until September 2040 if pediatric indication is granted
- Future generic competition will eventually impact SUNOSI revenue after 2040
- Other patent litigation with different parties remains unresolved
NEW YORK, May 27, 2025 (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 Hetero Labs Ltd. and certain of its affiliates (Hetero) 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 Hetero 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 Hetero 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 Hetero 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 other parties 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.
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:
Mark Jacobson
Chief Operating Officer
(212) 332-3243
mjacobson@axsome.com
Media:
Darren Opland
Director, Corporate Communications
(929) 837-1065
dopland@axsome.com
FAQ
When will Hetero's generic version of AXSM's SUNOSI be available in the market?
What is the patent litigation settlement between Axsome Therapeutics and Hetero Labs about?
Does AXSM face any other patent challenges for SUNOSI?
What regulatory approvals are needed for the AXSM-Hetero settlement agreement?
