Axsome Therapeutics Announces Settlement Agreement Resolving AUVELITY® (dextromethorphan HBr – bupropion HCl) Patent Litigation
Axsome Therapeutics (NASDAQ: AXSM) has reached a settlement agreement with Teva Pharmaceuticals regarding patent litigation for AUVELITY®, its treatment for CNS disorders. The litigation arose after Teva submitted an application to market a generic version of AUVELITY before Axsome's patent expiration.
Under the agreement, Axsome will grant Teva a license to sell its generic version of AUVELITY starting March 31, 2039 (if pediatric exclusivity is granted) or September 30, 2038 (if not granted), subject to FDA approval. The settlement terminates all ongoing litigation between the parties in the U.S. District Court for the District of New Jersey and resolves all outstanding patent litigation relating to AUVELITY.
The agreement will be submitted to the U.S. Federal Trade Commission and Department of Justice for review.
Axsome Therapeutics (NASDAQ: AXSM) ha raggiunto un accordo di transazione con Teva Pharmaceuticals riguardo le controversie sui brevetti per AUVELITY®, il suo trattamento per i disturbi del sistema nervoso centrale. La controversia è sorta dopo che Teva ha presentato una domanda per commercializzare una versione generica di AUVELITY prima della scadenza del brevetto di Axsome.
In base all'accordo, Axsome concederà a Teva una licenza per vendere la sua versione generica di AUVELITY a partire dal 31 marzo 2039 (se viene concessa l'esclusiva pediatrica) o dal 30 settembre 2038 (se non concessa), subordinata all'approvazione della FDA. L'accordo mette fine a tutte le controversie in corso tra le parti nella Corte Distrettuale degli Stati Uniti per il Distretto del New Jersey e risolve tutte le questioni di brevetto pendenti relative ad AUVELITY.
L'accordo sarà sottoposto alla Commissione Federale del Commercio e al Dipartimento di Giustizia degli Stati Uniti per una revisione.
Axsome Therapeutics (NASDAQ: AXSM) ha alcanzado un acuerdo de conciliación con Teva Pharmaceuticals respecto a la litigación de patentes para AUVELITY®, su tratamiento para trastornos del sistema nervioso central. La litigación surgió después de que Teva presentara una solicitud para comercializar una versión genérica de AUVELITY antes de la expiración de la patente de Axsome.
Bajo este acuerdo, Axsome otorgará a Teva una licencia para vender su versión genérica de AUVELITY a partir del 31 de marzo de 2039 (si se concede la exclusividad pediátrica) o el 30 de septiembre de 2038 (si no se concede), sujeto a la aprobación de la FDA. El acuerdo pone fin a toda la litigación pendiente entre las partes en el Tribunal de Distrito de EE. UU. para el Distrito de Nueva Jersey y resuelve todas las litigaciones de patentes pendientes relacionadas con AUVELITY.
El acuerdo se presentará a la Comisión Federal de Comercio de EE. UU. y al Departamento de Justicia para su revisión.
Axsome Therapeutics (NASDAQ: AXSM)는 CNS 장애 치료제 AUVELITY®에 대한 특허 소송과 관련하여 Teva Pharmaceuticals와 합의 계약을 체결하였습니다. 이 소송은 Teva가 Axsome의 특허 만료 이전에 AUVELITY의 제네릭 버전을 판매하기 위한 신청서를 제출한 후 제기되었습니다.
합의에 따라, Axsome은 Teva에게 AUVELITY의 제네릭 버전을 2039년 3월 31일부터 판매할 수 있는 라이센스를 부여합니다(소아 독점 특허가 부여될 경우) 또는 2038년 9월 30일부터(부여되지 않을 경우) 판매하며, 이는 FDA 승인이 필요합니다. 이 합의는 뉴저지 지방법원에서 당사자 간의 모든 진행 중인 소송을 종결하고 AUVELITY와 관련된 모든 미해결 특허 소송을 해결합니다.
이 합의는 미국 연방 거래 위원회 및 법무부에 제출되어 검토됩니다.
Axsome Therapeutics (NASDAQ: AXSM) a conclu un accord de règlement avec Teva Pharmaceuticals concernant les litiges en matière de brevets pour AUVELITY®, son traitement des troubles du système nerveux central. Le litige a surgi après que Teva ait soumis une demande pour commercialiser une version générique d'AUVELITY avant l'expiration du brevet d'Axsome.
Conformément à l'accord, Axsome accordera à Teva une licence pour vendre sa version générique d'AUVELITY à compter du 31 mars 2039 (si l'exclusivité pédiatrique est accordée) ou du 30 septembre 2038 (si ce n'est pas le cas), sous réserve de l'approbation de la FDA. Le règlement met fin à tous les litiges en cours entre les parties devant le tribunal de district des États-Unis pour le district du New Jersey et résout tous les litiges sur les brevets en cours concernant AUVELITY.
L'accord sera soumis à la Federal Trade Commission et au département de la Justice des États-Unis pour examen.
Axsome Therapeutics (NASDAQ: AXSM) hat mit Teva Pharmaceuticals eine Vergleichsvereinbarung bezüglich der Patentrechtsstreitigkeiten über AUVELITY®, seine Behandlung für Erkrankungen des zentralen Nervensystems, erzielt. Die Rechtsstreitigkeiten entstanden, nachdem Teva einen Antrag zur Vermarktung einer generischen Version von AUVELITY vor Ablauf des Axsome-Patents eingereicht hatte.
Gemäß der Vereinbarung wird Axsome Teva eine Lizenz erteilen, um seine generische Version von AUVELITY ab dem 31. März 2039 (falls die pädiatrische Exklusivität gewährt wird) oder ab dem 30. September 2038 (falls sie nicht gewährt wird) zu verkaufen, vorbehaltlich der Genehmigung durch die FDA. Der Vergleich beendet alle laufenden Rechtsstreitigkeiten zwischen den Parteien vor dem US-Bezirksgericht für den Bezirk New Jersey und löst alle ausstehenden Patentstreitigkeiten im Zusammenhang mit AUVELITY.
Die Vereinbarung wird der US-amerikanischen Federal Trade Commission und dem Justizministerium zur Prüfung vorgelegt.
- Secured patent protection for AUVELITY until at least September 2038
- Resolution of all outstanding patent litigation
- Protected market exclusivity for 14+ years
- Will face generic competition from Teva after September 2038
Insights
The settlement agreement between Axsome and Teva represents a major strategic victory for Axsome Therapeutics, effectively securing market exclusivity for AUVELITY until at least 2038. This agreement is particularly significant for several reasons:
The settlement terms are notably favorable, providing Axsome with 13-14 years of guaranteed market exclusivity from today. This extended protection period is important for AUVELITY, which treats major depressive disorder (MDD) in a market valued at several billion dollars annually. The agreement's timing aligns well with typical pharmaceutical patent settlements, which often occur 15-20 years before generic entry.
A key strategic element is the pediatric exclusivity provision, which could extend protection by six months to March 2039. This incentivizes Axsome to pursue pediatric studies, potentially expanding AUVELITY's market reach while gaining additional exclusivity. The settlement's structure, allowing for both scenarios, demonstrates sophisticated IP strategy planning.
From an investor perspective, this agreement significantly de-risks Axsome's revenue projections for AUVELITY. The clear timeline for generic entry allows for more accurate long-term forecasting and provides a substantial window for market penetration and revenue optimization. The resolution of patent litigation also removes a significant overhang on the stock, as patent challenges can create uncertainty and volatility in biotech valuations.
The settlement's requirement for FTC and DOJ review is standard practice and unlikely to face significant hurdles, given its alignment with typical pharmaceutical patent settlements. This agreement strengthens Axsome's overall IP portfolio position and validates their innovation in the CNS space, potentially benefiting future drug development and commercialization efforts.
NEW YORK, Feb. 10, 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 Teva Pharmaceuticals, Inc. (Teva) resolving all patent litigation related to Axsome’s AUVELITY® (dextromethorphan HBr – bupropion HCl) product. The litigation resulted from submission by Teva of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of AUVELITY in the United States prior to the expiration of applicable Axsome patents.
Under the terms of the settlement agreement, Axsome will grant Teva a license to sell its generic version of AUVELITY beginning on or after March 31, 2039, if pediatric exclusivity is granted for AUVELITY, or on or after September 30, 2038, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. In accordance with the agreement, the parties will terminate all ongoing litigation between Axsome and Teva regarding AUVELITY patents pending in the U.S. District Court for the District of New Jersey.
The settlement agreement resolves all outstanding patent litigation relating to AUVELITY.
“Axsome is proud of its commitment to innovating treatments aimed at improving the lives of the millions of patients living with central nervous system disorders. The resolution of this patent litigation underscores the value of that innovation as it relates to AUVELITY, and more broadly reflects the strength of Axsome’s intellectual property portfolio,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. “With our industry-leading neuroscience pipeline addressing difficult-to-treat conditions, we look forward to continuing to serve our patient communities through innovation and delivery of differentiated new medicines.”
As required by law, Axsome and Teva 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 and excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea 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 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 Teva's generic version of AUVELITY be available according to Axsome's settlement?
What is the impact of the AXSM-Teva patent settlement on AUVELITY market exclusivity?
How does the patent settlement affect AXSM's current litigation status?
What regulatory review is required for the AXSM-Teva settlement agreement?
