FDA Orange Book
Is there a generic for Vanflyta?
Vanflyta contains quizartinib. 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 Vanflyta (quizartinib). The Orange Book shows its last listed patent expires September 30, 2033 and its last listed exclusivity ends July 20, 2030.
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Vanflyta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 17.7MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 26.5MG BASE | Marketed (Rx) | None | 0 | None |
NDA 216993, held by DAIICHI SANKYO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vanflyta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9585892 | March 16, 2027 | Method of use | U-3661 | 216993 |
| 8129374 | March 16, 2027 | Method of use | U-3661 | 216993 |
| 8883783 | March 16, 2027 | Drug substance | None | 216993 |
| 8557810 | March 16, 2027 | Drug product | None | 216993 |
| 7820657 | September 26, 2028 | Drug substance | None | 216993 |
| 7968543 | August 15, 2029 | Drug product | U-3661 | 216993 |
| 8865710 | August 15, 2029 | Drug product | None | 216993 |
| 8836218 | March 23, 2030 | Method of use | U-3661 | 216993 |
| 9555040 | May 14, 2030 | Method of use | U-3661 | 216993 |
| 8357690 | February 26, 2031 | Method of use | U-3661 | 216993 |
| 9675549 | September 30, 2033 | Drug product | None | 216993 |
Vanflyta exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 20, 2028 | 216993 |
| ODE-437 | Orphan drug exclusivity | July 20, 2030 | 216993 |
Vanflyta NDC codes
Questions
Is there a generic for Vanflyta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vanflyta (quizartinib). The Orange Book shows its last listed patent expires September 30, 2033 and its last listed exclusivity ends July 20, 2030.
What is the generic name for Vanflyta?
The active ingredient in Vanflyta is quizartinib, per the FDA Orange Book.
When does the Vanflyta patent expire?
The last patent listed for Vanflyta in the Orange Book expires September 30, 2033. 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.