Axsome Therapeutics Settles Sunosi® (solriamfetol) Patent Litigation with Hikma Pharmaceuticals USA
Axsome Therapeutics (NASDAQ: AXSM) has reached a settlement agreement with Hikma Pharmaceuticals USA regarding patent litigation over Sunosi® (solriamfetol). The litigation arose from Hikma's submission of an Abbreviated New Drug Application seeking approval for a generic version of Sunosi in the United States.
Under the settlement terms, Axsome will grant Hikma a license to sell its generic version of Sunosi starting either September 1, 2040 (if pediatric exclusivity is granted) or March 1, 2040 (if no pediatric exclusivity is granted), subject to FDA approval. The agreement will be reviewed by the U.S. Federal Trade Commission and Department of Justice. Similar patent litigation against other parties regarding Sunosi remains pending in the U.S. District Court for the District of New Jersey.
Axsome Therapeutics (NASDAQ: AXSM) ha raggiunto un accordo di transazione con Hikma Pharmaceuticals USA riguardo a una controversia sui brevetti per Sunosi® (solriamfetol). La controversia è emersa a seguito della presentazione da parte di Hikma di una Domanda Abbreviata di Nuovo Farmaco per ottenere l'approvazione di una versione generica di Sunosi negli Stati Uniti.
Secondo i termini dell'accordo, Axsome concederà a Hikma una licenza per vendere la sua versione generica di Sunosi a partire dal 1° settembre 2040 (se verrà concessa l'esclusività pediatrica) o dal 1° marzo 2040 (se non verrà concessa l'esclusività pediatrica), soggetta all'approvazione della FDA. L'accordo sarà esaminato dalla Commissione Federale del Commercio degli Stati Uniti e dal Dipartimento di Giustizia. Una controversia simile sui brevetti contro altre parti riguardante Sunosi rimane pendente presso il Tribunale Distrettuale degli Stati Uniti per il Distretto del New Jersey.
Axsome Therapeutics (NASDAQ: AXSM) ha llegado a un acuerdo de conciliación con Hikma Pharmaceuticals USA en relación con un litigio de patentes sobre Sunosi® (solriamfetol). El litigio surgió a raíz de la presentación por parte de Hikma de una Solicitud Abreviada de Nuevo Medicamento para buscar la aprobación de una versión genérica de Sunosi en los Estados Unidos.
Bajo los términos del acuerdo, Axsome otorgará a Hikma una licencia para vender su versión genérica de Sunosi a partir del 1 de septiembre de 2040 (si se concede la exclusividad pediátrica) o del 1 de marzo de 2040 (si no se concede la exclusividad pediátrica), sujeto a la aprobación de la FDA. El acuerdo será revisado por la Comisión Federal de Comercio de EE. UU. y el Departamento de Justicia. Un litigio de patentes similar contra otras partes en relación con Sunosi sigue pendiente en el Tribunal de Distrito de EE. UU. para el Distrito de Nueva Jersey.
Axsome Therapeutics (NASDAQ: AXSM)는 Hikma Pharmaceuticals USA와 Sunosi® (solriamfetol)에 대한 특허 소송에 대한 합의 계약을 체결했습니다. 이 소송은 Hikma가 미국에서 Sunosi의 제네릭 버전에 대한 승인을 요청하는 약식 신약 신청서를 제출하면서 발생했습니다.
합의 조건에 따라 Axsome은 Hikma에게 FDA 승인을 조건으로 Sunosi의 제네릭 버전을 2040년 9월 1일(소아 독점권이 부여되는 경우) 또는 2040년 3월 1일(소아 독점권이 부여되지 않는 경우)부터 판매할 수 있는 라이센스를 부여합니다. 이 계약은 미국 연방 거래위원회와 법무부의 검토를 받게 됩니다. Sunosi와 관련하여 다른 당사자에 대한 유사한 특허 소송은 뉴저지 지방법원에서 계속 진행 중입니다.
Axsome Therapeutics (NASDAQ: AXSM) a conclu un accord de règlement avec Hikma Pharmaceuticals USA concernant un litige sur les brevets concernant Sunosi® (solriamfetol). Le litige est né de la soumission par Hikma d'une Demande Abbreviée de Nouveau Médicament pour obtenir l'approbation d'une version générique de Sunosi aux États-Unis.
Selon les termes de l'accord, Axsome accordera à Hikma une licence pour vendre sa version générique de Sunosi à partir du 1er septembre 2040 (si l'exclusivité pédiatrique est accordée) ou du 1er mars 2040 (si l'exclusivité pédiatrique n'est pas accordée), sous réserve de l'approbation de la FDA. L'accord sera examiné par la Commission fédérale du commerce des États-Unis et le Département de la justice. Un litige similaire sur les brevets contre d'autres parties concernant Sunosi reste en cours devant le tribunal de district des États-Unis pour le district du New Jersey.
Axsome Therapeutics (NASDAQ: AXSM) hat eine Vergleichsvereinbarung mit Hikma Pharmaceuticals USA bezüglich eines Patentstreits über Sunosi® (solriamfetol) erreicht. Der Streit entstand aus Hikmas Einreichung eines Abgekürzten Neuen Arzneimittelantrags, um die Genehmigung für eine generische Version von Sunosi in den Vereinigten Staaten zu beantragen.
Gemäß den Bedingungen des Vergleichs wird Axsome Hikma eine Lizenz erteilen, um ihre generische Version von Sunosi ab dem 1. September 2040 (wenn die pädiatrische Exklusivität gewährt wird) oder ab dem 1. März 2040 (wenn keine pädiatrische Exklusivität gewährt wird) zu verkaufen, vorbehaltlich der Genehmigung durch die FDA. Die Vereinbarung wird von der US-amerikanischen Wettbewerbsbehörde und dem Justizministerium überprüft. Ein ähnlicher Patentstreit gegen andere Parteien bezüglich Sunosi ist weiterhin beim US-Bezirksgericht für den Bezirk New Jersey anhängig.
- Patent protection for Sunosi secured until at least March 2040
- Settlement eliminates patent litigation uncertainty with Hikma
- Generic competition for Sunosi will begin by 2040
- Other patent litigation cases still pending with other parties
NEW YORK, March 05, 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 Hikma Pharmaceuticals USA, Inc. (Hikma) 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 Hikma of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. Under the terms of the settlement agreement, Axsome will grant Hikma 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 Hikma 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 the Company’s website at www.axsome.com.
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 circumstance.
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 Hikma's generic version of Sunosi be available according to the AXSM settlement?
What was the reason for the patent litigation between Axsome and Hikma Pharmaceuticals?
Does the Axsome-Hikma settlement resolve all pending Sunosi patent litigation?
What regulatory review is required for the AXSM-Hikma settlement agreement?
