FDA Orange Book · active-ingredient family
Cytarabine; daunorubicin
Cytarabine; daunorubicin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VYXEOS · NDA 209401
1
Brand (NDA)
0
Generics (ANDA)
15
Listed patents
2
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VYXEOSRLD | JAZZ PHARMS THERAP | NDA 209401 | — | Aug 03, 2017 |
Marketing exclusivity (2)
- ODE-350Orphan-drug exclusivity (7 years)
Mar 30, 2028
in 1 yr 10 mo
- PEDPediatric exclusivity (adds 6 months)
Sep 30, 2028
in 2 yr 4 mo
Listed patents (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8518437 | Jun 07, 2026 | 12 d ago | Product |
| 7850990 | Jan 23, 2027 | in 7 mo | ProductU-3147 |
| 9271931 | Jan 23, 2027 | in 7 mo | Product |
| 7850990*PED | Jul 23, 2027 | in 1 yr 1 mo | |
| 9271931*PED | Jul 23, 2027 | in 1 yr 1 mo | |
| 8022279 | Sep 14, 2027 | in 1 yr 3 mo | ProductU-3147 |
| 8022279*PED | Mar 14, 2028 | in 1 yr 9 mo | |
| 8092828 | Apr 01, 2029 | in 2 yr 10 mo | U-3147 |
| 8092828*PED | Oct 01, 2029 | in 3 yr 4 mo | |
| 10835492 | Oct 15, 2032 | in 6 yr 5 mo | U-3150 |
| 10028912 | Oct 15, 2032 | in 6 yr 5 mo | ProductU-3150 |
| 10166184 | Oct 15, 2032 | in 6 yr 5 mo | ProductU-3149 |
| 10028912*PED | Apr 15, 2033 | in 6 yr 11 mo | |
| 10835492*PED | Apr 15, 2033 | in 6 yr 11 mo | |
| 10166184*PED | Apr 15, 2033 | in 6 yr 11 mo |
Cytarabine; daunorubicin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
