Received two new U.S. Rezdiffra® (resmetirom) patents in F2/F3; both patents will be listed in the FDA's Orange Book
Received new U.S. resmetirom patent directed to a method of administering resmetirom to treat well-compensated cirrhosis (F4c)
CONSHOHOCKEN, Pa., July 13, 2026 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced that the United States Patent and Trademark Office (USPTO) issued three new resmetirom patents.
Bill Sibold, Chief Executive Officer of Madrigal, stated: "Building a robust patent estate is a core pillar of our long-term strategy. It gives us the runway to continue investing in innovation and extend our leadership in MASH. Last year, we secured our pivotal 2045 F2/F3 patent. Today, we're building on that foundation with three additional patents – two that reinforce our protection in F2/F3 and one supporting our potential F4c indication. Together, these patents further strengthen our robust patent estate and reflect our disciplined approach to maximizing the long-term value of Rezdiffra while reinforcing our leadership in MASH."
New U.S. Rezdiffra patents in F2/F3 to be listed in FDA's Orange Book
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U.S. Patent No. 12,667,575, directed to administering a weight-threshold step-down 60mg or 80mg resmetirom dose for patients with F2/F3 MASH also using a moderate CYP2C8 inhibitor. This patent issued on June 30, 2026, and is expected to provide protection to 2045.
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U.S. Patent No. 12,661,359, directed to the administration of rosuvastatin and resmetirom and limits the daily dose of rosuvastatin to a maximum of 20mg per day to reduce or eliminate dose-related side effects. This patent issued on June 23, 2026, and is expected to provide protection to 2042.
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New U.S. resmetirom patent in F4c
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U.S. Patent No. 12,661,361, directed to a method of administering resmetirom to treat well-compensated cirrhosis (F4c). This patent issued on June 23, 2026, and is expected to provide protection to 2042.
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About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra was the first medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit www.madrigalpharma.com.