REZDIFFRA Drug Patent Profile

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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 four patents protecting this drug.

This drug has one hundred and four patent family members in thirty-four 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:	104
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	51
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^: ⤷ Sign Up* 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.

US Patents and Regulatory Information for REZDIFFRA

REZDIFFRA is protected by four US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of REZDIFFRA is ⤷ Sign Up.

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.

Patents protecting REZDIFFRA

Methods of synthesizing thyroid hormone analogs and polymorphs thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS)

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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS)

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Method of synthesizing thyroid hormone analogs and polymorphs thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting REZDIFFRA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-002	Mar 14, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-001	Mar 14, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-003	Mar 14, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Madrigal	REZDIFFRA	resmetirom	TABLET;ORAL	217785-002	Mar 14, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>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

See the table below for patents covering REZDIFFRA around the world.

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Country	Patent Number	Title	Estimated Expiration
South Korea	102363776		⤷ Sign Up
Australia	2013315017	Method of synthesizing thyroid hormone analogs and polymorphs thereof	⤷ Sign Up
European Patent Office	1919878	DERIVES DE PYRIDAZINONE UTILISES COMME AGONISTES DU RECEPTEUR DE L'HORMONE THYROIDIENNE (PYRIDAZINONE DERIVATIVES AS THYROID HORMONE RECEPTOR AGONISTS)	⤷ Sign Up
Israel	275393	שיטה לסינתזת אנלוגים להורמון בלוטת התריס ופולימורפים שלהם (Method of synthesizing thyroid hormone analogs and polymorphs thereof)	⤷ Sign Up
Taiwan	202134217	Method of synthesizing thyroid hormone analogs and polymorphs thereof	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration