U.S. District Court Upholds Validity of CINVANTIĀ® Patents

    Date:

    ā€” Court Rules in Favor of Heron in Patent Lawsuit Against Fresenius Kabi USA, LLC ā€”

    SAN DIEGO, Dec. 3, 2024 /PRNewswire/ — Heron Therapeutics, Inc. HRTX (“Heron” or the “Company”), a commercial-stage biotechnology company, today announced that the U.S. District Court for the District of Delaware ruled in Heron’s favor in the Company’s patent litigation against Fresenius Kabi USA, LLC with respect to CINVANTIĀ® (aprepitant) injectable emulsion. The district court found that Heron’s U.S. Patent Nos. 9,561,229 and 9,974,794, which expire in 2035, are valid and would be infringed by Fresenius’ proposed generic product.

    The district court decision concludes the litigation initiated in July 2022 in response to Fresenius’ submission of an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval of a generic version of CINVANTIĀ®. As a result of the decision, Heron will seek an order from the Court prohibiting Fresenius from launching its generic CINVANTIĀ® until after the expiration of the patents in 2035. This decision is subject to appeal.

    “We are pleased with this anticipated result of the proceeding and will continue to vigorously defend the CINVANTIĀ® patent estate in the future,” saidĀ Craig Collard, Chief Executive Officer of Heron. “The team at Heron takes great pride in the result of our successful history of developing injectable products, which is demonstrated by the strength of our intellectual property and the performance of our innovative drugs like CINVANTIĀ® in serving patients with serious unmet needs.”

    AboutĀ Heron Therapeutics, Inc.

    Heron Therapeutics, Inc.Ā 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, visitĀ 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 theĀ 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

    (PRNewsfoto/Heron Therapeutics, Inc.)

    Ā 

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    SOURCE Heron Therapeutics, Inc.

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