Details for New Drug Application (NDA): 217785

NDA 217785 describes REZDIFFRA, which is a drug marketed by Madrigal and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the REZDIFFRA profile page.

The generic ingredient in REZDIFFRA is resmetirom. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the resmetirom profile page.

Summary for 217785

Tradename:	REZDIFFRA
Applicant:	Madrigal
Ingredient:	resmetirom
Patents:	8

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 217785

Constraining patent/regulatory exclusivity:

9,266,861

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 NDA: 217785

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

Suppliers and Packaging for NDA: 217785

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REZDIFFRA	resmetirom	TABLET;ORAL	217785	NDA	Madrigal Pharmaceuticals, Inc.	82576-060	82576-060-30	30 TABLET, COATED in 1 BOTTLE (82576-060-30)
REZDIFFRA	resmetirom	TABLET;ORAL	217785	NDA	Madrigal Pharmaceuticals, Inc.	82576-080	82576-080-30	30 TABLET, COATED in 1 BOTTLE (82576-080-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Mar 14, 2024	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 14, 2029
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	10,376,517	Patent Expiration:	Sep 17, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ADULTS WITH NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH) WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS)
Patent:	11,564,926	Patent Expiration:	Sep 17, 2033	Product Flag?	Y	Substance Flag?	Y	Delist Request?
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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