CONSHOHOCKEN, Pa., July 13, 2026
Madrigal Pharmaceuticals announced that the U.S. Patent and Trademark Office (USPTO) has issued three new U.S. patents covering resmetirom (Rezdiffra®), further expanding the company’s intellectual property portfolio for its approved treatment for metabolic dysfunction-associated steatohepatitis (MASH). Two of the newly issued patents strengthen protection for Rezdiffra in patients with F2/F3 MASH and will be listed in the FDA’s Orange Book, while a third patent covers the use of resmetirom for well-compensated cirrhosis (F4c), supporting the therapy’s continued clinical development in advanced liver disease.
New Patents Expand Protection for Approved Rezdiffra Therapy
Among the newly issued patents, U.S. Patent No. 12,667,575 covers a weight-threshold dose adjustment strategy using 60 mg or 80 mg resmetirom in patients with F2/F3 MASH receiving a moderate CYP2C8 inhibitor, with expected patent protection extending through 2045. A second patent, U.S. Patent No. 12,661,359, protects the co-administration of rosuvastatin and resmetirom, limiting rosuvastatin dosing to a maximum of 20 mg daily to reduce dose-related adverse effects. This patent is expected to remain in force until 2042. Both patents are scheduled for listing in the FDA’s Orange Book, reinforcing regulatory exclusivity for Rezdiffra.
Patent Supports Potential Expansion into Compensated Cirrhosis
The third newly issued patent, U.S. Patent No. 12,661,361, covers a method of administering resmetirom for the treatment of well-compensated MASH cirrhosis (F4c) and is expected to provide protection through 2042. The patent aligns with Madrigal’s ongoing Phase 3 outcomes trial evaluating Rezdiffra in patients with compensated cirrhosis, representing a potential future label expansion beyond its currently approved indication for moderate to advanced fibrosis. The company believes the expanded patent estate strengthens its long-term strategy while supporting continued investment in developing therapies for progressive liver disease.
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Intellectual Property Strategy Reinforces MASH Leadership
Rezdiffra is the first once-daily oral THR-β agonist approved by both the U.S. FDA and the European Commission for the treatment of MASH with moderate to advanced fibrosis (F2-F3). The latest patent awards build upon Madrigal’s previously secured intellectual property, including its pivotal F2/F3 patent extending protection to 2045. By expanding patent coverage across approved indications, dosing strategies, drug combinations, and future therapeutic applications, Madrigal continues to strengthen the commercial foundation supporting Rezdiffra while reinforcing its leadership position in the rapidly evolving MASH treatment landscape.
Source: Madrigal Pharmaceuticals press release
