BeiGene Announces Settlement of Litigation Against Generic Filer of BRUKINSA
BeiGene has settled patent litigation with MSN Pharmaceuticals regarding their attempt to market a generic version of BRUKINSA (zanubrutinib) in the U.S. Under the agreement, MSN cannot sell a generic version before June 15, 2037. The composition patent for BRUKINSA, expiring in April 2034, wasn't challenged by MSN. BRUKINSA, a BTK inhibitor approved in over 70 markets for B-cell malignancies, has the broadest label in its class globally. The settlement resolves all patent litigation against companies seeking to market generic versions of BRUKINSA, including a previous dismissal with Sandoz Inc.
BeiGene ha risolto una controversia legale sui brevetti con MSN Pharmaceuticals riguardo al tentativo di commercializzare una versione generica di BRUKINSA (zanubrutinib) negli Stati Uniti. In base all'accordo, MSN non può vendere una versione generica prima del 15 giugno 2037. Il brevetto di composizione per BRUKINSA, che scade ad aprile 2034, non è stato contestato da MSN. BRUKINSA, un inibitore BTK approvato in oltre 70 mercati per le neoplasie a cellule B, ha l'etichetta più ampia nella sua categoria a livello globale. L'accordo risolve tutte le controversie legali sui brevetti contro le aziende che cercano di commercializzare versioni generiche di BRUKINSA, incluso un precedente rigetto con Sandoz Inc.
BeiGene ha resuelto una disputa de patentes con MSN Pharmaceuticals en relación a su intento de comercializar una versión genérica de BRUKINSA (zanubrutinib) en los EE. UU. Según el acuerdo, MSN no podrá vender una versión genérica antes del 15 de junio de 2037. La patente de composición de BRUKINSA, que expira en abril de 2034, no fue impugnada por MSN. BRUKINSA, un inhibidor de BTK aprobado en más de 70 mercados para malignidades de células B, tiene la etiqueta más amplia en su clase a nivel global. El acuerdo resuelve todas las disputas de patentes contra las empresas que buscan comercializar versiones genéricas de BRUKINSA, incluido un despido previo con Sandoz Inc.
BeiGene은 MSN Pharmaceuticals와 미국에서 BRUKINSA (자누브루틴입) 제네릭 버전을 시장에 내놓으려는 시도를 두고 특허 소송을 해결했습니다. 이 계약에 따라 MSN은 2037년 6월 15일 이전에 제네릭 버전을 판매할 수 없습니다. BRUKINSA의 조성 특허는 2034년 4월에 만료되지만 MSN에 의해 도전받지 않았습니다. BRUKINSA는 B세포 악성종양을 위해 70개 이상의 시장에서 승인된 BTK 억제제로, 전 세계적으로 동급에서 가장 폭넓은 라벨을 가지고 있습니다. 이 합의는 BRUKINSA의 제네릭 버전을 시장에 내놓으려는 기업들에 대한 모든 특허 소송을 해결하며, Sandoz Inc.와의 이전 기각도 포함됩니다.
BeiGene a réglé un litige en matière de brevets avec MSN Pharmaceuticals concernant leur tentative de commercialiser une version générique de BRUKINSA (zanubrutinib) aux États-Unis. Selon l'accord, MSN ne peut pas vendre de version générique avant le 15 juin 2037. Le brevet de composition pour BRUKINSA, qui expirera en avril 2034, n'a pas été contesté par MSN. BRUKINSA, un inhibiteur de BTK approuvé dans plus de 70 marchés pour les malignités des cellules B, a l'étiquette la plus large dans sa catégorie à l'échelle mondiale. Le règlement met fin à tous les litiges en matière de brevets contre des entreprises cherchant à commercialiser des versions génériques de BRUKINSA, y compris une demande antérieure avec Sandoz Inc.
BeiGene hat einen Patentstreit mit MSN Pharmaceuticals beigelegt, der den Versuch betraf, eine generische Version von BRUKINSA (Zanubrutinib) in den USA auf den Markt zu bringen. Laut Vereinbarung darf MSN eine generische Version nicht vor dem 15. Juni 2037 verkaufen. Das Kompositionspatent für BRUKINSA, das im April 2034 abläuft, wurde von MSN nicht angefochten. BRUKINSA, ein BTK-Hemmer, der in über 70 Märkten für B-Zell-Malignome zugelassen ist, hat das umfangreichste Label in seiner Klasse weltweit. Die Einigung beendet alle Patentstreitigkeiten gegen Unternehmen, die versuchen, generische Versionen von BRUKINSA auf den Markt zu bringen, einschließlich einer früheren Abweisung mit Sandoz Inc.
- Patent protection for BRUKINSA secured until June 2037
- Composition patent validity remains unchallenged
- BRUKINSA approved in over 70 markets globally
- Resolution of all patent litigation related to generic versions
- Generic competition will enter market by 2037
Insights
This settlement represents a significant legal victory for BeiGene, securing BRUKINSA's market exclusivity until June 15, 2037. The agreement with MSN Pharmaceuticals effectively blocks generic competition for an extended period, well beyond the composition patent's 2034 expiration. The resolution of all patent litigation related to BRUKINSA, including the previous Sandoz case, strengthens BeiGene's market position.
The settlement's terms allow for potential timeline adjustments under certain circumstances, but the base protection until 2037 provides substantial commercial runway. Notably, MSN's decision not to challenge the composition patent (expiring 2034) indicates the strength of BeiGene's intellectual property portfolio. This comprehensive patent protection is particularly valuable given BRUKINSA's broad label approval in over 70 markets for various B-cell malignancies.
The settlement has significant positive implications for BeiGene's long-term revenue prospects. BRUKINSA, as a best-in-class BTK inhibitor, represents a major revenue driver with protected market exclusivity now extending to 2037. This extended protection period allows for continued market penetration and revenue growth without generic competition pressure.
The broad global approval across 70+ markets, combined with the comprehensive patent protection, positions BRUKINSA as a cornerstone asset in BeiGene's portfolio. The resolution of patent challenges removes a key market uncertainty and allows investors to more confidently model long-term revenue projections. This security in intellectual property rights is particularly valuable for a
Agreement provides for generic entry of innovative BTK inhibitor in 2037
Under the terms of the agreement, MSN will not be able to sell a generic version of BRUKINSA earlier than June 15, 2037, subject to potential acceleration or extension under certain customary circumstances. The composition of matter patent for BRUKINSA, expiring in April 2034, was not challenged by MSN in the litigation.
“Developed internally, BRUKINSA is a best-in-class BTK inhibitor with the broadest label of any medicine in its class globally. This settlement reaffirms our confidence in the intellectual property protecting this groundbreaking treatment and its exclusivity. Approved in over 70 markets for treating diverse B-cell malignancies, BRUKINSA exemplifies the strength of our R&D program and reinforces our commitment to delivering transformative medicines around the world,” said Chan Lee, General Counsel at BeiGene. “We continue to advance our innovative oncology treatments, relying on a robust patent system to safeguard our investment. Our focus remains on expanding access to this therapy and future innovations for cancer patients globally.”
The settlement resolves all patent litigation brought by BeiGene against companies that sought to market generic versions of BRUKINSA. BeiGene and Sandoz Inc. previously filed a joint stipulation to dismiss patent litigation brought by BeiGene in response to Sandoz’s ANDA seeking approval to market a generic version of BRUKINSA.
The Company recently announced its intent to change its name to BeOne, reaffirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.
About BeiGene
BeiGene, which plans to change its name to BeOne Medicines, is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of nearly 11,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the strength of BeiGene’s R&D program; BeiGene’s commitment to globally deliver transformative medicines; the ability of BeiGene to expand access to BRUKINSA; and BeiGene’s plans, commitments, aspirations and goals under the caption “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the
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Investors
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Source: BeiGene, Ltd.
FAQ
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