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Last Updated: November 7, 2024

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 five patents protecting this drug.

This drug has one hundred and six 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:106
US Patents:5
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
Drug Prices for REZDIFFRA

See drug prices for REZDIFFRA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for REZDIFFRA
Generic Entry Date for REZDIFFRA*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
NDA:
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 five 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)


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)


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)


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

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 ⤷  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 ⤷  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 217785-002 Mar 14, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  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.

Country Patent Number Title Estimated Expiration
Russian Federation 2008106058 ПРОИЗВОДНЫЕ ПИРИДАЗИНОНА В КАЧЕСТВЕ АГОНИСТОВ РЕЦЕПТОРА ТИРЕОИДНОГО ГОРМОНА ⤷  Sign Up
South Korea 102138750 ⤷  Sign Up
Ecuador SP088120 DERIVADOS DE PIRIDAZINONA COMO AGONISTAS DEL RECEPTORDE LA HORMONA TIROIDEA ⤷  Sign Up
Spain 2795450 ⤷  Sign Up
Spain 2349131 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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