Heron Therapeutics Announces Settlement with Mylan Related to CINVANTI庐 and APONVIE庐 Patent Litigations
Heron Therapeutics (NASDAQ: HRTX) has reached a settlement agreement with Mylan Pharmaceuticals, a Viatris company, regarding patent litigation for CINVANTI庐 and APONVIE庐 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 societ脿 di Viatris, riguardo alla controversia sui brevetti per le emulsioni iniettabili CINVANTI庐 e APONVIE庐. L'accordo concede a Mylan una licenza per commercializzare versioni generiche di entrambi i farmaci negli Stati Uniti a partire dal 1掳 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 societ脿 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 conciliaci贸n con Mylan Pharmaceuticals, una compa帽铆a de Viatris, respecto a la litigaci贸n por patentes de las emulsiones inyectables CINVANTI庐 y APONVIE庐. El acuerdo otorga a Mylan una licencia para comercializar versiones gen茅ricas 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 despu茅s de que Mylan solicitara la aprobaci贸n de la FDA para versiones gen茅ricas antes de la expiraci贸n de las patentes de Heron en 2035. Ambas compa帽铆as presentar谩n una solicitud para desestimar las litigaciones pendientes ante el Tribunal de Distrito de los Estados Unidos para el Distrito de Delaware.
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Heron Therapeutics (NASDAQ : HRTX) a conclu un accord de r猫glement avec Mylan Pharmaceuticals, une soci茅t茅 de Viatris, concernant un litige de brevets relatif aux 茅mulsions injectables CINVANTI庐 et APONVIE庐. Cet accord accorde 脿 Mylan une licence pour commercialiser des versions g茅n茅riques des deux m茅dicaments aux 脡tats-Unis 脿 partir du 1er juin 2032, ou plus t么t dans certaines circonstances.
Les litiges en mati猫re de brevets ont 茅t茅 initi茅s par Heron en septembre 2023 et janvier 2024, apr猫s que Mylan a demand茅 l'approbation de la FDA pour des versions g茅n茅riques avant l'expiration des brevets Heron en 2035. Les deux soci茅t茅s d茅poseront une requ锚te en annulation des litiges en cours aupr猫s du tribunal de district des 脡tats-Unis pour le district du Delaware.
Heron Therapeutics (NASDAQ: HRTX) hat eine Vergleichsvereinbarung mit Mylan Pharmaceuticals, einem Unternehmen von Viatris, bez眉glich Patentstreitigkeiten um die injizierbaren Emulsionen CINVANTI庐 und APONVIE庐 erzielt. Die Vereinbarung gew盲hrt Mylan eine Lizenz, generische Versionen beider Medikamente in den Vereinigten Staaten ab dem 1. Juni 2032 oder fr眉her unter bestimmten Bedingungen zu vermarkten.
Die Patentstreitigkeiten wurden von Heron im September 2023 und Januar 2024 eingeleitet, nachdem Mylan eine FDA-Zulassung f眉r generische Versionen vor dem Ablauf der Heron-Patente im Jahr 2035 beantragt hatte. Beide Unternehmen werden einen Antrag auf Einstellung der anh盲ngigen Verfahren beim US-Bezirksgericht f眉r 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
鈥斅�Company Grants Mylan a License to Market Generic CINVANTI庐 and APONVIE庐 Beginning in聽June 2032聽鈥�
These patent litigations were initiated by the Company in聽September 2023 and January 2024聽in response to Mylan's abbreviated new drug applications seeking聽United States Food and Drug Administration approval of generic versions of CINVANTI庐 and APONVIE庐, respectively, in聽the United States聽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聽U.S. District Court for the District of
About聽Heron Therapeutics, Inc.
Heron Therapeutics, Inc.聽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聽.
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聽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.
[email protected]
858-251-4400
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FAQ
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