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 four patents protecting this drug.
This drug has one hundred and four 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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Questions you can ask:
- What is the 5 year forecast for REZDIFFRA?
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Summary for REZDIFFRA
International Patents: | 104 |
US Patents: | 4 |
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 |
![REZDIFFRA drug patent expirations Drug patent expirations by year for REZDIFFRA](/p/graph/s/t/REZDIFFRA-patent-expirations.png)
![Drug Prices for REZDIFFRA](/p/graph/drug-price/REZDIFFRA.png)
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 four 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
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 | Y | Y | ⤷ 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 | 217785-003 | 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 | Y | Y | ⤷ Sign Up | ||
Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785-003 | Mar 14, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Madrigal | REZDIFFRA | resmetirom | TABLET;ORAL | 217785-001 | 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 |
---|---|---|---|
Malaysia | 142861 | THYROID HORMONE RECEPTOR AGONISTS | ⤷ Sign Up |
Norway | 340679 | ⤷ Sign Up | |
Japan | 2022078218 | 甲状腺ホルモンアナログ及びその多形体の合成方法 | ⤷ Sign Up |
Russian Federation | 2015114327 | СПОСОБ СИНТЕЗА АНАЛОГОВ ГОРМОНОВ ЩИТОВИДНОЙ ЖЕЛЕЗЫ И ИХ ПОЛИМОРФОВ | ⤷ Sign Up |
South Korea | 20180131647 | 갑상선 호르몬 유사체 및 이의 다형의 합성 방법 (METHOD OF SYNTHESIZING THYROID HORMONE ANALOGS AND POLYMORPHS THEREOF) | ⤷ Sign Up |
Japan | 6765408 | ⤷ Sign Up | |
Japan | 6616688 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |