Heron Therapeutics Settles Patent Litigation with Mylan for CINVANTI and APONVIE
• Heron Therapeutics has reached a settlement agreement with Mylan Pharmaceuticals to resolve ongoing patent litigations related to CINVANTI and APONVIE injectable emulsions.
• Under the settlement terms, Heron grants Mylan a license to market generic versions of both aprepitant products in the United States beginning June 1, 2032, approximately three years before patent expiration.
• The agreement concludes litigation initiated by Heron in response to Mylan's abbreviated new drug applications seeking FDA approval for generic versions prior to the 2035 patent expiration.
Federal Circuit Upholds Regeneron's Preliminary Injunction Against Samsung Bioepis in EYLEA Patent Dispute
• The Federal Circuit affirmed a preliminary injunction against Samsung Bioepis, preventing the sale of its biosimilar version of Regeneron's EYLEA (aflibercept) in the United States.
• The court established that filing an abbreviated Biologics License Application with plans for nationwide distribution creates sufficient "minimum contacts" for personal jurisdiction in any U.S. state.
• Samsung Bioepis failed to raise substantial questions about the validity of Regeneron's '865 patent, with the court clarifying that patent domination alone does not render a later patent obvious.
Glenmark Launches Generic Clindamycin Phosphate Foam for Dermatological Treatment
• Glenmark Pharmaceuticals Inc., USA has introduced Clindamycin Phosphate Foam 1%, a bioequivalent generic version of Evoclin® Foam, expanding their dermatology portfolio.
• The reference product Evoclin® Foam achieved annual sales of approximately $5.8 million in the 12-month period ending December 2024, indicating significant market potential.
• The launch strengthens Glenmark's position in the dermatology segment, with the company maintaining presence across Branded, Generics, and OTC segments globally.
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