CONSHOHOCKEN, PA — Madrigal Pharmaceuticals Inc. (NASDAQ: MDGL) has secured three new U.S. patents for its liver disease drug Rezdiffra, extending intellectual property protection for key treatment methods through as late as 2045 as the company strengthens its competitive position in the MASH market.
The company reported that the U.S. Patent and Trademark Office issued two patents covering use of Rezdiffra (resmetirom) in patients with F2/F3 metabolic dysfunction-associated steatohepatitis (MASH), both of which will be listed in the U.S. Food and Drug Administration’s Orange Book. A third patent covers use of resmetirom to treat well-compensated cirrhosis, or F4c.
One newly issued patent, U.S. Patent No. 12,667,575, covers administration of 60-milligram or 80-milligram resmetirom doses for F2/F3 MASH patients taking a moderate CYP2C8 inhibitor. The patent was issued June 30 and is expected to remain in force until 2045.
A second F2/F3 patent, U.S. Patent No. 12,661,359, covers co-administration of resmetirom with rosuvastatin while limiting the statin dose to 20 milligrams daily to reduce dose-related side effects. Issued June 23, the patent is expected to provide protection through 2042.
The third patent, U.S. Patent No. 12,661,361, covers a method of administering resmetirom to patients with well-compensated cirrhosis, or F4c. That patent was also issued June 23 and is expected to remain in effect through 2042.
The additional patents expand the intellectual property surrounding Rezdiffra, the first FDA-approved treatment for MASH, by protecting specific dosing regimens and potential future indications that could support the drug’s commercial exclusivity.
“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,” Chief Executive Officer Bill Sibold stated. “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.”
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