Madrigal Secures Key IP Milestone As U.S. Patent Office Issues Notice Of Allowance For Rezdiffra™ (Resmetirom) Patent
Madrigal wins patent for Rezdiffra dosing, securing U.S. protection for MASH drug through 2044.


Madrigal Pharmaceuticals, Inc., a company focused on developing treatments for metabolic dysfunction-associated steatohepatitis (MASH), has announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new patent related to its drug Rezdiffra™ (resmetirom). Rezdiffra is the first and only FDA-approved therapy for adults with noncirrhotic MASH, also referred to as NASH, who have moderate to advanced liver fibrosis.
Bill Sibold, Chief Executive Officer of Madrigal, stated, “This issuance marks a pivotal milestone in our long-term Rezdiffra strategy. 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.”
The newly allowed claims specifically cover the weight-based dosing regimen outlined in Rezdiffra’s FDA-approved labeling. Once granted, the patent will provide intellectual property protection for Rezdiffra in the U.S. through September 30, 2044. The patent will also be listed in the FDA’s Orange Book, which catalogs approved drug products with therapeutic equivalence evaluations.

Simantini Singh Deo works on the latest and trending news happening daily in the pharma world.
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