REZDIFFRA Drug Patent Profile

When do Rezdiffra patents expire, and what generic alternatives are available?

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 September 17, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for REZDIFFRA

International Patents:	126
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	1,021
Drug Prices:	Drug price information for REZDIFFRA
What excipients (inactive ingredients) are in REZDIFFRA?	REZDIFFRA excipients list
DailyMed Link:	REZDIFFRA at DailyMed

See drug prices for REZDIFFRA

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

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.

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

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
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-003	Mar 14, 2024		RX	Yes	Yes
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-001	Mar 14, 2024		RX	Yes	No

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

Australia

Brazil

Canada

China

Denmark

European Patent Office

Finland

Hong Kong

India

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Portugal

Russian Federation

Singapore

South Africa

South Korea

Spain

Taiwan

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.

Country	Patent Number	Title	Estimated Expiration
Norway	20080058
Portugal	4406594
Taiwan	I755628

Supplementary Protection Certificates for REZDIFFRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4406594	2026C/705	Belgium		PRODUCT NAME: RESMETIROM OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/25/1962 20250819
4406594	PA2026507	Lithuania		PRODUCT NAME: RESMETIROMAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/25/1962 20250818
4406594	CA 2026 00008	Denmark		PRODUCT NAME: RESMETIROM ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/25/1962 20250819

DrugChatter Q&A for REZDIFFRA

How does rezdiffra treat nash?
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