FDA Orange Book
Is there a generic for Iqirvo?
Iqirvo contains elafibranor. 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 Iqirvo (elafibranor). The Orange Book shows its last listed patent expires March 5, 2044 and its last listed exclusivity ends June 10, 2031.
Run it in Rivvi
Map Iqirvo 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.
Iqirvo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 80MG | Marketed (Rx) | None | 0 | None |
NDA 218860, held by IPSEN BIOPHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Iqirvo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11857523 | March 30, 2037 | Method of use | U-3955 | 218860 |
| 11850223 | March 30, 2037 | Method of use | U-1854 | 218860 |
| 11331292 | March 30, 2037 | Method of use | U-1854 | 218860 |
| 11185519 | March 30, 2037 | Method of use | U-3955 | 218860 |
| 12310935 | March 30, 2037 | Method of use | U-1854 | 218860 |
| 12295928 | March 30, 2037 | Method of use | U-1854 | 218860 |
| 12295927 | March 30, 2037 | Method of use | U-1854 | 218860 |
| 12233038 | March 30, 2037 | Method of use | U-1854 | 218860 |
| 12589086 | March 30, 2037 | Method of use | U-4473 | 218860 |
| 12673035 | March 5, 2044 | Drug product | U-1854 | 218860 |
Iqirvo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | June 10, 2029 | 218860 |
| ODE-486 | Orphan drug exclusivity | June 10, 2031 | 218860 |
Iqirvo NDC codes
Questions
Is there a generic for Iqirvo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Iqirvo (elafibranor). The Orange Book shows its last listed patent expires March 5, 2044 and its last listed exclusivity ends June 10, 2031.
What is the generic name for Iqirvo?
The active ingredient in Iqirvo is elafibranor, per the FDA Orange Book.
When does the Iqirvo patent expire?
The last patent listed for Iqirvo in the Orange Book expires March 5, 2044. 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.