Generic Rezdiffra Availability
Last updated on Apr 10, 2024.
Rezdiffra is a brand name of resmetirom, approved by the FDA in the following formulation(s):
REZDIFFRA (resmetirom - tablet;oral)
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Manufacturer: MADRIGAL
Approval date: March 14, 2024
Strength(s): 60MG [RLD], 80MG [RLD], 100MG [RLD]
Has a generic version of Rezdiffra been approved?
No. There is currently no therapeutically equivalent version of Rezdiffra available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Rezdiffra. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Methods of synthesizing thyroid hormone analogs and polymorphs thereof
Patent 10,376,517
Issued: August 13, 2019
Inventor(s): Taub Rebecca & Reynolds Charles H. & Shu Lianhe & Wang Ping & Choi Duk SoonThe disclosure describes methods of synthesis of pyridazinone compounds as thyroid hormone analogs and their prodrugs. Preferred methods according to the disclosure allow for large-scale preparation of pyridazinone compounds having high purity. In some embodiments, preferred methods according to the disclosure also allow for the preparation of pyridazinone compounds in better yield than previously used methods for preparing such compounds. Also disclosed are morphic forms of a pyridazinone compound. Further disclosed is a method for treating resistance to thyroid hormone in a subject having at least one TRβ mutation.
Patent expiration dates:
- September 17, 2033✓
- September 17, 2033
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Patent 11,564,926
Patent expiration dates:
- September 17, 2033✓✓✓
- September 17, 2033
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Patent 7,452,882
Patent expiration dates:
- September 12, 2026✓✓
- September 12, 2026
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Method of synthesizing thyroid hormone analogs and polymorphs thereof
Patent 9,266,861
Issued: February 23, 2016
Inventor(s): Hester & II D. Keith & Duguid Robert J. & Kelly Martha J. & Chasnoff Anna & Dong Gang & Crow Edwin L. & Choi Duk Soon & Shu Lianhe & Wang PingThe disclosure describes methods of synthesis of pyridazinone compounds as thyroid hormone analogs and their prodrugs. Preferred methods according to the disclosure allow for large-scale preparation of pyridazinone compounds having high purity. In some embodiments, preferred methods according to the disclosure also allow for the preparation of pyridazinone compounds in better yield than previously used methods for preparing such compounds. Also disclosed are morphic forms of a pyridazinone compound. Further disclosed is a method for treating resistance to thyroid hormone in a subject having at least one TRβ mutation.
Patent expiration dates:
- September 17, 2033✓✓
- September 17, 2033
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- March 14, 2029 - NEW CHEMICAL ENTITY
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.