Resmetirom Patent Expiration

Resmetirom is Used for treating adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis. It was first introduced by Madrigal Pharmaceuticals Inc in its drug Rezdiffra on Mar 14, 2024.


Resmetirom Patents

Given below is the list of patents protecting Resmetirom, along with the drug name that holds that patent and the company name owning that drug.

Filter patents by

NEW
Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Rezdiffra US12377104 Feb 04, 2045 Madrigal
Rezdiffra US12667575 Methods For Treating A Fatty Liver Disease Feb 04, 2045 Madrigal
Rezdiffra US12661359 Therapeutic Combinations Of Rosuvastatin And Resmetirom For The Treatment Of Liver Disorders Or Lipid Disorders Jan 28, 2042 Madrigal
Rezdiffra US10376517 Methods of synthesizing thyroid hormone analogs and polymorphs thereof Sep 17, 2033 Madrigal
Rezdiffra US11564926 Methods of synthesizing thyroid hormone analogs and polymorphs thereof Sep 17, 2033 Madrigal
Rezdiffra US11986481 Method of synthesizing thyroid hormone analogs and polymorphs thereof Sep 17, 2033 Madrigal
Rezdiffra US9266861 Method of synthesizing thyroid hormone analogs and polymorphs thereof Sep 17, 2033 Madrigal
Rezdiffra US7452882 Thyroid hormone analogs Sep 12, 2027 Madrigal



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Resmetirom's patents.

Given below is the list recent legal activities going on the following patents of Resmetirom.

Activity Date Patent Number
Patent litigations
transaction for FDA Determination of Regulatory Review Period 27 Jan, 2026 US9266861
transaction for FDA Determination of Regulatory Review Period 27 Jan, 2026 US7452882
transaction for FDA Determination of Regulatory Review Period 21 Nov, 2025 US7452882
transaction for FDA Determination of Regulatory Review Period 21 Nov, 2025 US9266861
Second letter to regulating agency to determine regulatory review period 19 Aug, 2025 US7452882
Second letter to regulating agency to determine regulatory review period 19 Aug, 2025 US9266861
Letter from FDA or Dept of Agriculture re PTE application 12 Aug, 2025 US9266861
Letter from FDA or Dept of Agriculture re PTE application 12 Aug, 2025 US7452882
Information Disclosure Statement (IDS) Filed 12 Aug, 2025 US7452882
Change in Power of Attorney (May Include Associate POA) 26 Jun, 2024 US7452882


Resmetirom's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List



Clinical Trials

Recent Clinical Trials on Resmetirom:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Study of Resmetirom in Children and Adolescents With MASH Madrigal Pharmaceuticals, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE2
Resmetirom in Patients With MASH and HFpEF Madrigal Pharmaceuticals, Inc. NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1
Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH Madrigal Pharmaceuticals, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE2
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES) Madrigal Pharmaceuticals, Inc. NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
A Study to Evaluate the Use of Resmetirom in Participants With MASLD and HIV Naga P. Chalasani NA RECRUITING
(Jul 1, 2026)
PHASE2
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE) Madrigal Pharmaceuticals, Inc. NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3


Resmetirom Generic API Manufacturers

Given below is the list of companies who have filed for Resmetirom generic, along with the locations of their manufacturing plants worldwide.


Resmetirom News

Madrigal Receives Conditional Approval for MASH Medication Rezdiffra in Europe - TradingView

20 Aug, 2025

Madrigal's Rezdiffra: A Patent-Guarded Success with Growth in Europe and Future Developments...

05 Aug, 2025

See More