Orange Book product · Brand (NDA)
VONJO
PACRITINIB CITRATE
At a glance
Feb 28, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 28, 2022
4 yr 4 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Feb 28, 2027
in 8 mo
Patent 9573964 expires
Listed method-of-use patent (U-3332) expiration.
May 05, 2028
in 1 yr 11 mo
Patent 9573964 expires
Listed method-of-use patent (U-3331) expiration.
May 05, 2028
in 1 yr 11 mo
Patent 8153632 expires
Listed drug substance patent expiration.
Jan 17, 2029
in 2 yr 7 mo
Patent 8153632 expires
Listed drug substance patent expiration.
Jan 17, 2029
in 2 yr 7 mo
Exclusivity ends · ODE-397
Orphan-drug exclusivity (7 years)
Feb 28, 2029
in 2 yr 9 mo
Patent 8980873 expires
Listed drug substance patent expiration.
Mar 25, 2030
in 3 yr 10 mo
Patent 8980873 expires
Listed drug substance patent expiration.
Mar 25, 2030
in 3 yr 10 mo
Pharmaceutical detail
Active ingredient
PACRITINIB CITRATE
Strength
EQ 100MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 208712
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)
- NCENew chemical entity exclusivity (5 years)
Feb 28, 2027
in 8 mo
- ODE-397Orphan-drug exclusivity (7 years)
Feb 28, 2029
in 2 yr 9 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9573964 | May 05, 2028 | in 1 yr 11 mo | U-3332 |
| 9573964 | May 05, 2028 | in 1 yr 11 mo | U-3331 |
| 8153632 | Jan 17, 2029 | in 2 yr 7 mo | SubstanceProductU-3332 |
| 8153632 | Jan 17, 2029 | in 2 yr 7 mo | SubstanceProductU-3331 |
| 8980873 | Mar 25, 2030 | in 3 yr 10 mo | SubstanceProductU-3331 |
| 8980873 | Mar 25, 2030 | in 3 yr 10 mo | SubstanceProductU-3332 |
