FDA Orange Book
Is there a generic for Livdelzi?
Livdelzi contains seladelpar. 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 Livdelzi (seladelpar). The Orange Book shows its last listed patent expires March 13, 2038 and its last listed exclusivity ends August 14, 2031.
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Livdelzi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
NDA 217899, held by GILEAD SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Livdelzi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7301050 | August 2, 2027 | Drug substance, Drug product | None | 217899 |
| 7709682 | September 13, 2027 | Drug substance | None | 217899 |
| 11596614 | March 19, 2035 | Method of use | U-1854 | 217899 |
| 11406611 | March 19, 2035 | Method of use | U-1854 | 217899 |
| 9486428 | March 19, 2035 | Method of use | U-1854 | 217899 |
| 10272058 | March 13, 2038 | Method of use | U-1854 | 217899 |
Livdelzi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 14, 2029 | 217899 |
| ODE-486 | Orphan drug exclusivity | August 14, 2031 | 217899 |
Livdelzi NDC codes
Questions
Is there a generic for Livdelzi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Livdelzi (seladelpar). The Orange Book shows its last listed patent expires March 13, 2038 and its last listed exclusivity ends August 14, 2031.
What is the generic name for Livdelzi?
The active ingredient in Livdelzi is seladelpar, per the FDA Orange Book.
When does the Livdelzi patent expire?
The last patent listed for Livdelzi in the Orange Book expires March 13, 2038. 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.