Axsome Therapeutics Reaches Agreement to Dismiss Sunosi® (Solriamfetol) Patent Litigation with Sandoz Inc.
Axsome Therapeutics (NASDAQ: AXSM) has announced an agreement with Sandoz Inc. to dismiss the patent litigation related to Axsome's product Sunosi® (solriamfetol). The litigation was pending in the U.S. District Court for the District of New Jersey and stemmed from Sandoz's submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to market a generic equivalent of Sunosi in the United States. As part of the agreement, Sandoz has withdrawn its ANDA for a generic equivalent of Sunosi, resulting in the dismissal of the litigation without prejudice.
Axsome Therapeutics (NASDAQ: AXSM) ha annunciato un accordo con Sandoz Inc. per ritirare la controversia legale relacionada al prodotto di Axsome Sunosi® (solriamfetol). La causa era pendente presso il Tribunale Distrettuale degli Stati Uniti per il Distretto del New Jersey ed era sorta dalla presentazione da parte di Sandoz di una domanda abbreviata di approvazione di un nuovo farmaco (ANDA) alla FDA, per ottenere l'approvazione per commercializzare un equivalente generico di Sunosi negli Stati Uniti. Come parte dell'accordo, Sandoz ha ritirato la sua ANDA per un equivalente generico di Sunosi, con conseguente archiviazione della controversia senza pregiudizio.
Axsome Therapeutics (NASDAQ: AXSM) ha anunciado un acuerdo con Sandoz Inc. para desestimar el litigio de patentes relacionado con el producto de Axsome Sunosi® (solriamfetol). El litigio estaba pendiente en el Tribunal de Distrito de EE. UU. para el Distrito de Nueva Jersey y surgió de la presentación por parte de Sandoz de una Solicitud Abreviada de Nuevo Medicamento (ANDA) a la FDA, buscando la aprobación para comercializar un equivalente genérico de Sunosi en los Estados Unidos. Como parte del acuerdo, Sandoz ha retirado su ANDA para un equivalente genérico de Sunosi, lo que resultó en la desestimación del litigio sin perjuicio.
Axsome Therapeutics (NASDAQ: AXSM)는 Sandoz Inc.와 Axsome의 제품 Sunosi® (solriamfetol)에 대한 특허 소송을 취하하기로 합의했다고 발표했습니다. 이 소송은 뉴저지 지방법원에서 진행 중이었으며, Sandoz가 FDA에 Sunosi의 제네릭 버전 마케팅 승인을 요청하는 간소화된 신약 신청(ANDA)을 제출한 것에서 비롯되었습니다. 계약의 일환으로, Sandoz는 Sunosi의 제네릭에 대한 ANDA를 철회했습니다 그 결과 소송은 기각되었습니다.
Axsome Therapeutics (NASDAQ: AXSM) a annoncé un accord avec Sandoz Inc. pour mettre un terme au litige concernant le brevet lié au produit d'Axsome Sunosi® (solriamfetol). Le litige était en cours devant le Tribunal de District des États-Unis pour le District du New Jersey et découlait de la soumission par Sandoz d'une Demande Abbreviée de Nouveau Médicament (ANDA) à la FDA, sollicitant l'approbation pour commercialiser un équivalent générique de Sunosi aux États-Unis. Dans le cadre de l'accord, Sandoz a retiré son ANDA pour un équivalent générique de Sunosi, ce qui a entraîné le rejet du litige sans préjugé.
Axsome Therapeutics (NASDAQ: AXSM) hat eine Vereinbarung mit Sandoz Inc. angekündigt, um die Patentrechtsstreitigkeiten im Zusammenhang mit Axsome's Produkt Sunosi® (solriamfetol) zu beenden. Der Rechtsstreit war beim US-Bezirksgericht für den Bezirk New Jersey anhängig und resultierte aus Sandoz' Einreichung eines verkürzten Antrags auf ein neues Arzneimittel (ANDA) bei der FDA, um die Genehmigung zu erhalten, ein generisches Äquivalent von Sunosi in den Vereinigten Staaten zu vermarkten. Im Rahmen der Vereinbarung hat Sandoz seinen ANDA zurückgezogen für ein generisches Äquivalent von Sunosi, was zur Abweisung des Rechtsstreits ohne Vorurteil führte.
- Patent litigation with Sandoz Inc. over Sunosi® has been dismissed
- Sandoz withdrew its ANDA for a generic equivalent of Sunosi
- Potential threat of generic competition for Sunosi® has been eliminated
- None.
Insights
The dismissal of the patent litigation between Axsome and Sandoz is a significant development for Axsome Therapeutics. This outcome effectively protects Axsome's market exclusivity for Sunosi, a key product in their portfolio. The withdrawal of Sandoz's ANDA indicates that Axsome's patents for Sunosi remain unchallenged, which is important for maintaining their competitive advantage in the central nervous system disorders market.
From a legal perspective, the dismissal "without prejudice" means that Sandoz could theoretically refile their ANDA in the future. However, this seems unlikely in the short term given the current withdrawal. This resolution avoids costly and time-consuming litigation, allowing Axsome to focus resources on product development and commercialization rather than legal battles.
This agreement is positive for Axsome's financial outlook. By preventing the entry of a generic competitor, Axsome preserves its revenue stream from Sunosi. This is particularly important as Sunosi is one of Axsome's key commercial products. The absence of generic competition allows Axsome to maintain pricing power and potentially expand market share without immediate threat.
Investors should note that this development reduces near-term risks to Axsome's revenue projections. It also potentially lowers legal expenses that would have been incurred from ongoing litigation. While the exact financial impact isn't quantified, this news should be viewed favorably in terms of Axsome's ability to protect its intellectual property and sustain its commercial strategy for Sunosi.
The dismissal of this patent litigation strengthens Axsome's position in the narcolepsy and obstructive sleep apnea markets, where Sunosi is indicated. Without imminent generic competition, Axsome can continue to invest in marketing and potentially expand Sunosi's market share. This is important in the competitive landscape of sleep disorder treatments.
Looking ahead, this development may impact Axsome's strategic planning. With a clearer runway for Sunosi, the company might allocate more resources to expand its indications or enhance its market penetration. For investors, this outcome reduces uncertainty around one of Axsome's key products, potentially making the company's growth narrative more compelling in the biotechnology sector.
NEW YORK, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has reached agreement with Sandoz Inc. (Sandoz) to dismiss the patent litigation related to Axsome’s product Sunosi® (solriamfetol). The litigation, which was pending in the United States District Court for the District of New Jersey, resulted from submission by Sandoz of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. Sandoz withdrew its ANDA for a generic equivalent of Sunosi, and, as a result, the litigation has been dismissed without prejudice.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. (“Axsome” or the “Company”) is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We 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 continued commercial success of our Sunosi® and Auvelity® products and the success of our efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our 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 our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; 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 continued commercialization of Sunosi and Auvelity 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; unforeseen circumstances or other disruptions to normal business operations arising from or related to geopolitical 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.
Axsome Contacts:
Investors:
Mark Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
One World Trade Center, 22nd Floor
New York, NY 10007
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com
Media:
Darren Opland
Director, Corporate Communications
Axsome Therapeutics, Inc.
One World Trade Center, 22nd Floor
New York, NY 10007
Tel: 929-837-1065
Email: dopland@axsome.com
www.axsome.com
FAQ
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