Heron Therapeutics Announces Settlement with Mylan Related to CINVANTI® and APONVIE® Patent Litigations
Heron Therapeutics (NASDAQ: HRTX) has reached a settlement agreement with Mylan Pharmaceuticals, a Viatris company, regarding patent litigation for CINVANTI® and APONVIE® injectable emulsions. The settlement grants Mylan a license to market generic versions of both drugs in the United States starting June 1, 2032, or earlier under certain circumstances.
The patent litigations were initiated by Heron in September 2023 and January 2024 after Mylan sought FDA approval for generic versions before the Heron Patents' expiration in 2035. Both companies will file for dismissal of the pending litigations with the U.S. District Court for the District of Delaware.
Heron Therapeutics (NASDAQ: HRTX) ha raggiunto un accordo di transazione con Mylan Pharmaceuticals, una società di Viatris, riguardo alla controversia sui brevetti per le emulsioni iniettabili CINVANTI® e APONVIE®. L'accordo concede a Mylan una licenza per commercializzare versioni generiche di entrambi i farmaci negli Stati Uniti a partire dal 1° giugno 2032, o prima in determinate circostanze.
Le controversie sui brevetti erano state avviate da Heron nel settembre 2023 e gennaio 2024, dopo che Mylan aveva richiesto l'approvazione FDA per versioni generiche prima della scadenza dei brevetti Heron nel 2035. Entrambe le società presenteranno una richiesta di archiviazione delle cause pendenti presso il Tribunale Distrettuale degli Stati Uniti per il Distretto del Delaware.
Heron Therapeutics (NASDAQ: HRTX) ha llegado a un acuerdo de conciliación con Mylan Pharmaceuticals, una compañía de Viatris, respecto a la litigación por patentes de las emulsiones inyectables CINVANTI® y APONVIE®. El acuerdo otorga a Mylan una licencia para comercializar versiones genéricas de ambos medicamentos en Estados Unidos a partir del 1 de junio de 2032, o antes bajo ciertas circunstancias.
Las litigaciones por patentes fueron iniciadas por Heron en septiembre de 2023 y enero de 2024 después de que Mylan solicitara la aprobación de la FDA para versiones genéricas antes de la expiración de las patentes de Heron en 2035. Ambas compañías presentarán una solicitud para desestimar las litigaciones pendientes ante el Tribunal de Distrito de los Estados Unidos para el Distrito de Delaware.
Heron Therapeutics (NASDAQ: HRTX)는 Viatris의 자회사인 Mylan Pharmaceuticals와 CINVANTI® 및 APONVIE® 주사 에멀젼에 대한 특허 소송과 관련하여 합의에 도달했습니다. 이번 합의로 Mylan은 미국 내에서 두 약품의 제네릭 버전을 2032년 6월 1일부터, 특정 조건 하에서는 그 이전부터 판매할 수 있는 라이선스를 부여받았습니다.
특허 소송은 Heron이 2023년 9월과 2024년 1월에 시작했으며, 이는 Mylan이 Heron 특허가 2035년에 만료되기 전에 FDA 승인을 요청한 데 따른 것입니다. 양사는 델라웨어 연방 지방법원에 현재 진행 중인 소송 취하 신청을 제출할 예정입니다.
Heron Therapeutics (NASDAQ : HRTX) a conclu un accord de règlement avec Mylan Pharmaceuticals, une société de Viatris, concernant un litige de brevets relatif aux émulsions injectables CINVANTI® et APONVIE®. Cet accord accorde à Mylan une licence pour commercialiser des versions génériques des deux médicaments aux États-Unis à partir du 1er juin 2032, ou plus tôt dans certaines circonstances.
Les litiges en matière de brevets ont été initiés par Heron en septembre 2023 et janvier 2024, après que Mylan a demandé l'approbation de la FDA pour des versions génériques avant l'expiration des brevets Heron en 2035. Les deux sociétés déposeront une requête en annulation des litiges en cours auprès du tribunal de district des États-Unis pour le district du Delaware.
Heron Therapeutics (NASDAQ: HRTX) hat eine Vergleichsvereinbarung mit Mylan Pharmaceuticals, einem Unternehmen von Viatris, bezüglich Patentstreitigkeiten um die injizierbaren Emulsionen CINVANTI® und APONVIE® erzielt. Die Vereinbarung gewährt Mylan eine Lizenz, generische Versionen beider Medikamente in den Vereinigten Staaten ab dem 1. Juni 2032 oder früher unter bestimmten Bedingungen zu vermarkten.
Die Patentstreitigkeiten wurden von Heron im September 2023 und Januar 2024 eingeleitet, nachdem Mylan eine FDA-Zulassung für generische Versionen vor dem Ablauf der Heron-Patente im Jahr 2035 beantragt hatte. Beide Unternehmen werden einen Antrag auf Einstellung der anhängigen Verfahren beim US-Bezirksgericht für den Bezirk Delaware stellen.
- Settlement provides clarity on generic entry timeline until 2032
- Protection of patent rights until 2032, 3 years before patent expiration in 2035
- Resolution eliminates ongoing litigation costs and uncertainty
- Potential revenue impact from generic competition starting June 2032
- Agreement allows for earlier generic entry under certain circumstances
— Company Grants Mylan a License to Market Generic CINVANTI® and APONVIE® Beginning in June 2032 —
These patent litigations were initiated by the Company in September 2023 and January 2024 in response to Mylan's abbreviated new drug applications seeking United States Food and Drug Administration approval of generic versions of CINVANTI® and APONVIE®, respectively, in the United States prior to the expiration of the Heron Patents in 2035. In connection with the settlement, the Company and Mylan will file a proposed Stipulation and Order of Dismissal with the U.S. District Court for the District of
About Heron Therapeutics, Inc.
Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.
Forward-looking Statements
This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.
Investor Relations and Media Contact:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
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SOURCE Heron Therapeutics, Inc.
FAQ
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