Aquestive Therapeutics Broadens Patent Estate for Anaphylm™

Core Viewpoint - Aquestive Therapeutics has received two additional U.S. patents for Anaphylm, extending its protection until at least 2037, which reinforces its position in the market for treating severe allergic reactions [1][2][7]. Patent Protection - The newly issued patents include U.S. patent number 12,427,121 and U.S. patent number 12,443,850, which cover the proprietary composition for Anaphylm, an epinephrine prodrug sublingual film [2][3]. - These patents are part of a broader intellectual property strategy that includes multiple pending and planned patent applications across various continents [2]. Product Overview - Anaphylm is designed as a device-free, sublingual film that offers a patient-friendly alternative to traditional epinephrine injections, addressing the fear of needles among patients [3][4]. - The product is small, lightweight, and begins to dissolve upon contact, requiring no water or swallowing for administration [4]. Regulatory Timeline - The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm is set for January 31, 2026, pending FDA approval [3][6]. Company Background - Aquestive Therapeutics focuses on advancing innovative medicines through proprietary technologies, including PharmFilm and Adrenaverse™, to improve patient care [5]. - The company has four commercialized products and collaborates with other pharmaceutical companies to bring new molecules to market [5].