rezdiffra Drug Patent Profile

Name: rezdiffra Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which patents cover Rezdiffra, and when can generic versions of Rezdiffra launch?

Rezdiffra is a drug marketed by Madrigal and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and twenty-six patent family members in thirty-seven countries.

The generic ingredient in REZDIFFRA is resmetirom. One supplier is listed for this compound. Additional details are available on the resmetirom profile page.

DrugPatentWatch^® Generic Entry Outlook for Rezdiffra

Rezdiffra will be eligible for patent challenges on March 14, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 14, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for rezdiffra

International Patents:	126
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	1,109
Drug Prices:	Drug price information for rezdiffra
What excipients (inactive ingredients) are in rezdiffra?	rezdiffra excipients list
DailyMed Link:	rezdiffra at DailyMed

Drug patent expirations by year for rezdiffra

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for rezdiffra

Generic Entry Date for rezdiffra^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 217785 Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for rezdiffra

Drug Class	Thyroid Hormone Receptor beta Agonist
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Thyroid Hormone Receptor beta Agonists

US Patents and Regulatory Information for rezdiffra

rezdiffra is protected by six US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of rezdiffra is ⤷ Start Trial.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-001	Mar 14, 2024		RX	Yes	No	11,986,481	⤷ Start Trial				⤷ Start Trial
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-003	Mar 14, 2024		RX	Yes	Yes	12,377,104	⤷ Start Trial				⤷ Start Trial
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-001	Mar 14, 2024		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-001	Mar 14, 2024		RX	Yes	No	12,377,104	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for rezdiffra

When does loss-of-exclusivity occur for rezdiffra?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4848
Patent: AGONISTAS DEL RECEPTOR DE LA HORMONA TIROIDEA
Estimated Expiration: ⤷ Start Trial

Australia

Patent: 06271721
Patent: Pyridazinone derivatives as thyroid hormone receptor agonists
Estimated Expiration: ⤷ Start Trial

Austria

Patent: 80524
Estimated Expiration: ⤷ Start Trial

Canada

Patent: 14529
Patent: DERIVES DE PYRIDAZINONE UTILISES COMME AGONISTES DU RECEPTEUR DE L'HORMONE THYROIDIENNE (PYRIDAZINONE DERIVATIVES AS THYROID HORMONE RECEPTOR AGONISTS)
Estimated Expiration: ⤷ Start Trial

Costa Rica

Patent: 44
Patent: AGONISTAS DEL RECEPTOR DE LA HORMONATIROIDEA
Estimated Expiration: ⤷ Start Trial

Croatia

Patent: 0100633
Estimated Expiration: ⤷ Start Trial

Denmark

Patent: 19878
Estimated Expiration: ⤷ Start Trial

Israel

Patent: 8476
Patent: PYRIDAZINONE DERIVATIVES AS THYROID HORMONE RECEPTOR AGONISTS
Estimated Expiration: ⤷ Start Trial

Japan

Patent: 09501759
Estimated Expiration: ⤷ Start Trial

Norway

Patent: 0679
Estimated Expiration: ⤷ Start Trial

Portugal

Patent: 19878
Estimated Expiration: ⤷ Start Trial

Russian Federation

Patent: 79295
Patent: ПРОИЗВОДНЫЕ ПИРИДАЗИНОНА В КАЧЕСТВЕ АГОНИСТОВ РЕЦЕПТОРА ТИРЕОИДНОГО ГОРМОНА (PYRIDASINONE DERIVATIVES AS AGONISTS OF THYROID HORMONE RECEPTOR)
Estimated Expiration: ⤷ Start Trial

South Korea

Patent: 080019297
Patent: PYRIDAZINONE DERIVATIVES AS THYROID HORMONE RECEPTOR AGONISTS
Estimated Expiration: ⤷ Start Trial

Taiwan

Patent: 30636
Estimated Expiration: ⤷ Start Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering rezdiffra around the world.

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2668960	СПОСОБ СИНТЕЗА АНАЛОГОВ ГОРМОНОВ ЩИТОВИДНОЙ ЖЕЛЕЗЫ И ИХ ПОЛИМОРФОВ (METHOD OF SYNTHESIS OF ANALOGUES OF HORMONES OF THE THYROID GLAND AND THEIR POLYMORPHS)	⤷ Start Trial
Japan	6899413		⤷ Start Trial
Lithuania	4406594		⤷ Start Trial
Taiwan	I652260		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for rezdiffra

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4406594	C20265007	Finland	⤷ Start Trial
4406594	301369	Netherlands	⤷ Start Trial	PRODUCT NAME: RESMETIROM OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/25/1962 20250819
4406594	PA2026507	Lithuania	⤷ Start Trial	PRODUCT NAME: RESMETIROMAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/25/1962 20250818
4406594	2026C/705	Belgium	⤷ Start Trial	PRODUCT NAME: RESMETIROM OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/25/1962 20250819
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description