Details for New Drug Application (NDA): 217785
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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 five patents protecting this drug. Additional details are available on the REZDIFFRA profile page.
The generic ingredient in REZDIFFRA is resmetirom. One supplier is listed for this compound. Additional details are available on the resmetirom profile page.
The generic ingredient in REZDIFFRA is resmetirom. 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: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217785
Generic Entry Date for 217785*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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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