Orange Book product · Brand (NDA)
VYXEOS
CYTARABINE; DAUNORUBICIN
At a glance
Aug 03, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
16
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 03, 2017
9 yr ago
Patent 8518437 expires
Listed drug product patent expiration.
Jun 07, 2026
12 d ago
Today
Patent 7850990 expires
Listed drug product patent expiration.
Jan 23, 2027
in 7 mo
Patent 9271931 expires
Listed drug product patent expiration.
Jan 23, 2027
in 7 mo
Patent 7850990*PED expires
Listed listed patent expiration.
Jul 23, 2027
in 1 yr 1 mo
Patent 9271931*PED expires
Listed listed patent expiration.
Jul 23, 2027
in 1 yr 1 mo
Patent 8022279 expires
Listed drug product patent expiration.
Sep 14, 2027
in 1 yr 3 mo
Patent 8022279*PED expires
Listed listed patent expiration.
Mar 14, 2028
in 1 yr 9 mo
Exclusivity ends · ODE-350
Orphan-drug exclusivity (7 years)
Mar 30, 2028
in 1 yr 10 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Sep 30, 2028
in 2 yr 4 mo
Patent 8092828 expires
Listed method-of-use patent (U-3147) expiration.
Apr 01, 2029
in 2 yr 10 mo
Patent 8092828*PED expires
Listed listed patent expiration.
Oct 01, 2029
in 3 yr 4 mo
Patent 10028912 expires
Listed drug product patent expiration.
Oct 15, 2032
in 6 yr 5 mo
Patent 10028912 expires
Listed drug product patent expiration.
Oct 15, 2032
in 6 yr 5 mo
Patent 10166184 expires
Listed drug product patent expiration.
Oct 15, 2032
in 6 yr 5 mo
Patent 10835492 expires
Listed method-of-use patent (U-3150) expiration.
Oct 15, 2032
in 6 yr 5 mo
Patent 10028912*PED expires
Listed listed patent expiration.
Apr 15, 2033
in 6 yr 11 mo
Patent 10166184*PED expires
Listed listed patent expiration.
Apr 15, 2033
in 6 yr 11 mo
Patent 10835492*PED expires
Listed listed patent expiration.
Apr 15, 2033
in 6 yr 11 mo
Pharmaceutical detail
Active ingredient
CYTARABINE; DAUNORUBICIN
Strength
100MG;44MG
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 209401
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
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 (16)
| 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 | |
| 10028912 | Oct 15, 2032 | in 6 yr 5 mo | ProductU-3150 |
| 10028912 | Oct 15, 2032 | in 6 yr 5 mo | ProductU-3149 |
| 10166184 | Oct 15, 2032 | in 6 yr 5 mo | ProductU-3149 |
| 10835492 | Oct 15, 2032 | in 6 yr 5 mo | U-3150 |
| 10028912*PED | Apr 15, 2033 | in 6 yr 11 mo | |
| 10166184*PED | Apr 15, 2033 | in 6 yr 11 mo | |
| 10835492*PED | Apr 15, 2033 | in 6 yr 11 mo |
