FDA Orange Book
Is there a generic for Fruzaqla?
Fruzaqla contains fruquintinib. 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 Fruzaqla (fruquintinib). The Orange Book shows its last listed patent expires September 7, 2035 and its last listed exclusivity ends November 8, 2028.
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Fruzaqla products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 1MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 5MG | Marketed (Rx) | None | 0 | None |
NDA 217564, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Fruzaqla patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8212033 | May 9, 2028 | Method of use | U-3753 | 217564 |
| 7829574 | March 23, 2032 | Drug substance, Drug product | None | 217564 |
| 11046674 | September 7, 2035 | Method of use | U-3753 | 217564 |
| 10519142 | September 7, 2035 | Drug substance, Drug product | U-3753 | 217564 |
Fruzaqla exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 8, 2028 | 217564 |
Fruzaqla NDC codes
Questions
Is there a generic for Fruzaqla?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Fruzaqla (fruquintinib). The Orange Book shows its last listed patent expires September 7, 2035 and its last listed exclusivity ends November 8, 2028.
What is the generic name for Fruzaqla?
The active ingredient in Fruzaqla is fruquintinib, per the FDA Orange Book.
When does the Fruzaqla patent expire?
The last patent listed for Fruzaqla in the Orange Book expires September 7, 2035. 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.