Orange Book product · Brand (NDA)
SOTYKTU
DEUCRAVACITINIB
At a glance
Sep 09, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 09, 2022
3 yr 10 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 09, 2027
in 1 yr 3 mo
Exclusivity ends · I-986
New indication exclusivity (3 years)
Mar 06, 2029
in 2 yr 9 mo
Patent 10000480 expires
Listed drug substance patent expiration.
Nov 07, 2033
in 7 yr 6 mo
Patent 11021475 expires
Listed method-of-use patent (U-3434) expiration.
Nov 07, 2033
in 7 yr 6 mo
Patent RE47929 expires
Listed drug substance patent expiration.
Nov 07, 2033
in 7 yr 6 mo
Patent RE47929 expires
Listed drug substance patent expiration.
Nov 07, 2033
in 7 yr 6 mo
Patent 12521390 expires
Listed drug product patent expiration.
Feb 11, 2043
in 16 yr 11 mo
Patent 12521390 expires
Listed drug product patent expiration.
Feb 11, 2043
in 16 yr 11 mo
Pharmaceutical detail
Active ingredient
DEUCRAVACITINIB
Strength
6MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 214958
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)
Sep 09, 2027
in 1 yr 3 mo
- I-986New indication exclusivity (3 years)
Mar 06, 2029
in 2 yr 9 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10000480 | Nov 07, 2033 | in 7 yr 6 mo | SubstanceProduct |
| 11021475 | Nov 07, 2033 | in 7 yr 6 mo | U-3434 |
| RE47929 | Nov 07, 2033 | in 7 yr 6 mo | SubstanceProductU-4452 |
| RE47929 | Nov 07, 2033 | in 7 yr 6 mo | SubstanceProductU-3434 |
| 12521390 | Feb 11, 2043 | in 16 yr 11 mo | ProductU-3434 |
| 12521390 | Feb 11, 2043 | in 16 yr 11 mo | ProductU-4451 |
