FDA Orange Book
Is there a generic for Rezdiffra?
Rezdiffra contains resmetirom. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rezdiffra (resmetirom). The Orange Book shows its last listed patent expires February 4, 2045 and its last listed exclusivity ends March 14, 2029.
Run it in Rivvi
Map Rezdiffra and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Rezdiffra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 60MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 80MG | Marketed (Rx) | None | 0 | None |
NDA 217785, held by MADRIGAL PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rezdiffra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7452882 | September 12, 2027 | Drug substance, Drug product | None | 217785 |
| 11986481 | September 17, 2033 | Method of use | U-3861 | 217785 |
| 11564926 | September 17, 2033 | Drug substance, Drug product | U-3861 | 217785 |
| 10376517 | September 17, 2033 | Method of use | U-3861 | 217785 |
| 9266861 | September 17, 2033 | Drug substance, Drug product | None | 217785 |
| 12661359 | January 28, 2042 | Method of use | U-4568 | 217785 |
| 12667575 | February 4, 2045 | Method of use | U-4567 | 217785 |
| 12377104 | February 4, 2045 | Method of use | U-3861 | 217785 |
Rezdiffra exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 14, 2029 | 217785 |
Rezdiffra NDC codes
Questions
Is there a generic for Rezdiffra?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rezdiffra (resmetirom). The Orange Book shows its last listed patent expires February 4, 2045 and its last listed exclusivity ends March 14, 2029.
What is the generic name for Rezdiffra?
The active ingredient in Rezdiffra is resmetirom, per the FDA Orange Book.
When does the Rezdiffra patent expire?
The last patent listed for Rezdiffra in the Orange Book expires February 4, 2045. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.