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Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the United States Patent and Trademark Office (USPTO) has issued two additional U.S. patents related to Anaphylm, the Company's novel epinephrine prodrug sublingual film.
"We are pleased with the issuance of these additional patents for Anaphylm, extending protection for the product through at least 2037," said Dan Barber, President and CEO of Aquestive. "These claims cover the proprietary composition for Anaphylm, which enables the oral sublingual film delivery of an epinephrine prodrug. By leveraging our proprietary technology platforms, PharmFilm® and Adrenaverse™, in this inventive way, we are addressing significant unmet needs in severe allergic reactions, while reinforcing patent protection for Anaphylm. These patents are the result of a broad intellectual property strategy that includes many other multi-continent patent applications pending and planned."
The USPTO has issued Aquestive U.S. patent number 12,427,121 entitled "Enhanced Delivery Epinephrine Compositions," and U.S. patent number 12,443,850 entitled "Enhanced Delivery Epinephrine and Prodrug Compositions." These composition of matter patents feature formulations including prodrugs of epinephrine and other components designed to facilitate oral mucosal absorption via film. Each patent is expected to expire on May 4, 2037, subject to any extensions thereof.
Anaphylaxis is a severe, rapid allergic reaction requiring immediate application of epinephrine, but many patients hesitate to use epinephrine injections due to fear of needles. Aquestive's product candidate Anaphylm is the first sublingual epinephrine film, offering a device-free, patient-friendly alternative, if approved by the United States Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm is scheduled for January 31, 2026.
Posted In: AQST
