Orange Book product · Brand (NDA)
CIBINQO
ABROCITINIB
At a glance
Jan 14, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 14, 2022
4 yr 6 mo ago
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Feb 09, 2026
4 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jan 14, 2027
in 7 mo
Patent 9545405 expires
Listed drug substance patent expiration.
Feb 19, 2034
in 7 yr 9 mo
Patent 9549929 expires
Listed method-of-use patent (U-3195) expiration.
Feb 19, 2034
in 7 yr 9 mo
Patent 9035074 expires
Listed drug substance patent expiration.
Jan 14, 2036
in 9 yr 9 mo
Pharmaceutical detail
Active ingredient
ABROCITINIB
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213871
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
- NPPNew patient population exclusivity (3 years)
Feb 09, 2026
4 mo ago
- NCENew chemical entity exclusivity (5 years)
Jan 14, 2027
in 7 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9545405 | Feb 19, 2034 | in 7 yr 9 mo | SubstanceProduct |
| 9549929 | Feb 19, 2034 | in 7 yr 9 mo | U-3195 |
| 9035074 | Jan 14, 2036 | in 9 yr 9 mo | SubstanceProduct |
