Resmetirom - Generic Drug Details
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What are the generic drug 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 | 217785-003 | Mar 14, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785-003 | Mar 14, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785-002 | Mar 14, 2024 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785-002 | Mar 14, 2024 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785-001 | Mar 14, 2024 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785-003 | Mar 14, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785-003 | Mar 14, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| >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 resmetirom
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 1919878 | ⤷ Subscribe | |
| Mexico | 364661 | METODO PARA SINTETIZAR LOS ANALOGOS DE HORMONA TIROIDEA Y LEUCOCITOS POLIMORFONUCLEARES DE LOS MISMOS. (METHOD OF SYNTHESIZING THYROID HORMONE ANALOGS AND POLYMORPHS THEREOF.) | ⤷ Subscribe |
| South Korea | 20210083381 | 갑상선 호르몬 유사체 및 이의 다형의 합성 방법 (METHOD OF SYNTHESIZING THYROID HORMONE ANALOGS AND POLYMORPHS THEREOF) | ⤷ Subscribe |
| China | 105008335 | Method of synthesizing thyroid hormone analogs and polymorphs thereof | ⤷ Subscribe |
| South Korea | 20150056630 | 갑상선 호르몬 유사체 및 이의 다형의 합성 방법 (METHOD OF SYNTHESIZING THYROID HORMONE ANALOGS AND POLYMORPHS THEREOF) | ⤷ Subscribe |
| Croatia | P20100633 | ⤷ Subscribe | |
| China | 108101851 | 合成甲状腺激素类似物及其多形体的方法 (Method of synthesizing thyroid hormone analogs and polymorphs thereof) | ⤷ Subscribe |
| >Country | >Patent Number | >Title | >Estimated Expiration |
