RESMETIROM - Generic Drug Details
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What are the generic sources for resmetirom and what is the scope of freedom to operate?
Resmetirom
is the generic ingredient in one branded drug marketed by Madrigal and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Resmetirom has one hundred and six patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for RESMETIROM
| International Patents: | 106 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 4 |
| Patent Applications: | 97 |
| What excipients (inactive ingredients) are in RESMETIROM? | RESMETIROM excipients list |
| DailyMed Link: | RESMETIROM at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RESMETIROM
Generic Entry Date for RESMETIROM*:
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.
Recent Clinical Trials for RESMETIROM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Madrigal Pharmaceuticals, Inc. | Phase 3 |
US Patents and Regulatory Information for RESMETIROM
| 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 | 217785-002 | Mar 14, 2024 | RX | Yes | No | ⤷ 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 | ||
| Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785-002 | 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 | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
