FDA Orange Book
Is there a generic for Fotivda?
Fotivda contains tivozanib. 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 Fotivda (tivozanib). The Orange Book shows its last listed patent expires November 5, 2039 and its last listed exclusivity ends March 10, 2026.
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Fotivda products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 0.89MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 1.34MG BASE | Marketed (Rx) | None | 0 | None |
NDA 212904, held by AVEO PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Fotivda patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7166722 | November 16, 2028 | Drug substance, Drug product | None | 212904 |
| 11504365 | November 5, 2039 | Method of use | U-3476 | 212904 |
Fotivda exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 10, 2026 | 212904 |
Fotivda NDC codes
Questions
Is there a generic for Fotivda?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Fotivda (tivozanib). The Orange Book shows its last listed patent expires November 5, 2039 and its last listed exclusivity ends March 10, 2026.
What is the generic name for Fotivda?
The active ingredient in Fotivda is tivozanib, per the FDA Orange Book.
When does the Fotivda patent expire?
The last patent listed for Fotivda in the Orange Book expires November 5, 2039. 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.