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Madrigal Pharmaceuticals Receives Notice of Allowance from U.S. Patent and Trademark Office for New U.S. Patent Covering Rezdiffra™ (Resmetirom)
• Provides Protection Through Sept. 2044; Will Be Listed in FDA’s Orange Book CONSHOHOCKEN, Pa., July 16, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals,
About this update from Madrigal Pharmaceuticals, Inc.
[{"type":"text","content":"• Provides Protection Through Sept. 2044; Will Be Listed in FDA’s Orange Book CONSHOHOCKEN, Pa., July 16, 2025 (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) has issued a Notice of Allowance covering the FDA-approved use of Rezdiffra™ (resmetirom), the first and only FDA-approved treatment for adults with noncirrhotic MASH (also known as NASH) with moderate to advanced liver fibrosis. The Notice of Allowance includes claims directed to Rezdiffra’s commercial weight-threshold dosing regimen as prescribed in the FDA-approved label. The U.S. patent scheduled to issue from this application provides protection through Sept. 30, 2044, and will be listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. “This issuance marks a pivotal milestone in our long-term Rezdiffra strategy,” said Bill Sibold, Chief Executive Officer of Madrigal. “It recognizes the value of our pioneering clinical development program and will allow our team to continue driving innovation for patients with MASH for years to come.” About Madrigal PharmaceuticalsMadrigal 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 is the first and only medication approved by the FDA for the treatment of MASH with moderate to advanced fibrosis (consistent with stages F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (consistent with stage F4c). For more information, visit www.madrigalpharma.com. Forward-Looking StatementsThis press release includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements related to the expected benefit of the new patent, when issued, and Rezdiffra’s role as a potential found...