FDA Orange Book
Is there a generic for Vyxeos?
Vyxeos contains daunorubicin and cytarabine. 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 Vyxeos (daunorubicin and cytarabine). The Orange Book shows its last listed patent expires April 15, 2033 and its last listed exclusivity ends September 30, 2028.
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Vyxeos products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 100MG;44MG | Marketed (Rx) | None | 0 | None |
NDA 209401, held by JAZZ PHARMACEUTICALS THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vyxeos patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8518437 | June 7, 2026 | Drug product | None | 209401 |
| 7850990 | January 23, 2027 | Drug product | U-3147 | 209401 |
| 9271931 | January 23, 2027 | Drug product | None | 209401 |
| 7850990*PED | July 23, 2027 | Method of use | None | 209401 |
| 9271931*PED | July 23, 2027 | Method of use | None | 209401 |
| 8022279 | September 14, 2027 | Drug product | U-3147 | 209401 |
| 8022279*PED | March 14, 2028 | Method of use | None | 209401 |
| 8092828 | April 1, 2029 | Method of use | U-3147 | 209401 |
| 8092828*PED | October 1, 2029 | Method of use | None | 209401 |
| 10835492 | October 15, 2032 | Method of use | U-3150 | 209401 |
| 10028912 | October 15, 2032 | Drug product | U-3150 | 209401 |
| 10028912 | October 15, 2032 | Drug product | U-3149 | 209401 |
| 10166184 | October 15, 2032 | Drug product | U-3149 | 209401 |
| 10028912*PED | April 15, 2033 | Method of use | None | 209401 |
| 10835492*PED | April 15, 2033 | Method of use | None | 209401 |
| 10166184*PED | April 15, 2033 | Method of use | None | 209401 |
Vyxeos exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-350 | Orphan drug exclusivity | March 30, 2028 | 209401 |
| PED | Pediatric exclusivity | September 30, 2028 | 209401 |
Vyxeos NDC codes
Questions
Is there a generic for Vyxeos?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vyxeos (daunorubicin and cytarabine). The Orange Book shows its last listed patent expires April 15, 2033 and its last listed exclusivity ends September 30, 2028.
What is the generic name for Vyxeos?
The active ingredient in Vyxeos is daunorubicin and cytarabine, per the FDA Orange Book.
When does the Vyxeos patent expire?
The last patent listed for Vyxeos in the Orange Book expires April 15, 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.