Mezzion Secures Key U.S. Patent for Udenafil in Fontan Patients, Extending Exclusivity to Early 2040s
Key Insights
Mezzion Pharmaceuticals (search) received U.S. patent allowance for udenafil's use in improving exercise capacity in Fontan patients, with protection extending into the early 2040s.
The patent covers chronic, twice-daily oral administration of udenafil for approximately 70,000 individuals worldwide living with Fontan physiology who currently have no FDA-approved treatment options.
The company is advancing JURVIGO (search) (udenafil), a highly selective oral PDE5 (search) inhibitor, through a global Phase 3 FUEL-2 trial as a potential first-in-class therapy for single ventricle congenital heart disease.
Mezzion Pharmaceuticals (search) announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a key patent application covering the use of udenafil to improve exercise capacity in Fontan patients. The patent, from the company's 2020-filed FUEL patent family, is expected to extend U.S. protection for JURVIGO (search) (udenafil) into the early 2040s, pending FDA approval and extensions.
Patent Protection Details
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. The patent also extends to additional cardiopulmonary exercise testing (CPET) endpoints.
The patent carries a baseline expiration date of July 24, 2040. Subject to FDA approval of udenafil and regulatory review, Mezzion anticipates 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. Additional six-month pediatric exclusivity could potentially extend U.S. protection into the early 2040s, providing a long exclusivity runway that could delay meaningful generic competition into the next decade.
Addressing Critical Unmet Medical Need
Mezzion is developing JURVIGO (search) (udenafil), a highly selective oral PDE5 (search) 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.
Clinical Development Progress
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. Mezzion is advancing JURVIGO (search) through this global Phase 3 program as a potential first-in-class therapy for patients with single ventricle congenital heart disease and Fontan physiology.
"This allowance marks a pivotal milestone in our long-term strategy for JURVIGO (search)," 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."
JURVIGO (search) is an investigational drug that has not been approved by the U.S. Food and Drug Administration or any other regulatory authority, and its safety and efficacy have not been established.