Mezzion Announces U.S. Patent Allowance Strengthening Udenafil Exclusivity in Fontan Patients
Mezzion Announces U.S. Patent Allowance Strengthening Udenafil Exclusivity in Fontan Patients |
| [03-December-2025] |
Key method-of-use patent expected to extend U.S. protection for JURVIGO® (udenafil) into the early 2040s, pending FDA approval and extensions FORT LEE, N.J., Dec. 3, 2025 /PRNewswire/ -- Mezzion Pharmaceuticals, Inc. (Mezzion), a clinical-stage rare disease biopharmaceutical company developing the first treatment specifically for people born with single ventricle congenital heart disease (SV-CHD) who are living with Fontan circulation, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a key U.S. patent application from the company's 2020-filed FUEL patent family covering the use of udenafil to improve exercise capacity in Fontan patients.
The allowed patent includes broad, age-agnostic method-of-use claims covering chronic, twice-daily oral administration of udenafil (or a pharmaceutically acceptable salt) in Fontan patients to improve exercise capacity, with important dependent claims extending to additional cardiopulmonary exercise testing (CPET) endpoints. The patent is expected to have a baseline expiration date of July 24, 2040. Subject to FDA approval of udenafil and regulatory review, Mezzion anticipates that the patent will be eligible for listing in the FDA's "Orange Book" and for patent term extension of up to five years, capped at 14 years from approval, with additional six-month pediatric exclusivity potentially extending U.S. protection into the early 2040s. Together, these protections, if granted, are expected to provide a long U.S. exclusivity runway and could delay meaningful generic competition into the next decade. "This allowance marks a pivotal milestone in our long-term strategy for JURVIGO," said Dean Park, Chairman and CEO of Mezzion. "It reflects years of work with investigators, families and advocates in the Fontan community, and it helps ensure that, if approved, JURVIGO can be supported, studied and made available to people living with Fontan circulation for many years to come. A stronger and longer U.S. patent position gives us greater confidence to keep investing in the FUEL program and future innovations for the Fontan community." Mezzion is developing JURVIGO® (udenafil), a highly selective oral PDE5 inhibitor, as the first potential approved pharmacotherapy for approximately 70,000 individuals living with Fontan physiology worldwide. The Fontan community currently has no FDA-approved treatment options and faces high morbidity and mortality. Recent health-economic analyses from Additional Ventures and others estimate that complex congenital heart disease imposes an annual economic burden in the United States of approximately $74 billion. The ongoing global confirmatory Phase 3 FUEL-2 trial is currently enrolling patients in the U.S. and Asia, with European sites in start-up. About Mezzion Pharmaceuticals Forward-Looking Statements Trademarks Media Contacts:
SOURCE Mezzion Pharmaceuticals, Inc | ||
Company Codes: Korea:140410 (KOSDAQ),Korea:140410 |
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