Heron Therapeutics, Inc., a biotechnology company based in Cary, North Carolina, has reached a settlement agreement with
Mylan Pharmaceuticals, Inc., a subsidiary of
Viatris Inc., effectively resolving ongoing patent disputes in the U.S. District Court for the District of Delaware. These litigations involved Heron's injectable emulsion products,
CINVANTI® and APONVIE®.
The settlement allows
Mylan to market generic versions of these treatments in the United States starting June 1, 2032, aligning with the protection granted by the patents listed in the Orange Book. The agreement also includes provisions for potentially earlier marketing under specific conditions.
The legal actions were initiated by Heron in late 2023 and early 2024 after Mylan filed applications to the U.S. Food and Drug Administration to produce generic alternatives to CINVANTI® and APONVIE®. These applications aimed to gain approval before the original patents' expiration in 2035. Following the settlement, both companies plan to submit a joint request to the court for dismissal of the pending lawsuits.
Heron Therapeutics, Inc. is dedicated to developing and commercializing therapeutic innovations that enhance patient care. The company employs advanced science and patented technologies to offer solutions for acute care and oncology patients, aiming to set new standards in medical treatment.
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