Orange Book product · Brand (NDA)
EUCRISA
CRISABOROLE
At a glance
Dec 14, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 14, 2016
9 yr 8 mo ago
Exclusivity ends · D-191
New indication / change exclusivity (3 years)
Apr 03, 2026
3 mo ago
Today
Patent 8501712 expires
Listed method-of-use patent (U-1932) expiration.
Feb 16, 2027
in 8 mo
Patent 9682092 expires
Listed method-of-use patent (U-1932) expiration.
Feb 16, 2027
in 8 mo
Patent 8501712*PED expires
Listed listed patent expiration.
Aug 16, 2027
in 1 yr 2 mo
Patent 9682092*PED expires
Listed listed patent expiration.
Aug 16, 2027
in 1 yr 2 mo
Patent 8039451 expires
Listed drug substance patent expiration.
Jun 29, 2029
in 3 yr 1 mo
Patent 8039451*PED expires
Listed listed patent expiration.
Dec 29, 2029
in 3 yr 7 mo
Patent 8168614 expires
Listed method-of-use patent (U-1932) expiration.
Jan 20, 2030
in 3 yr 8 mo
Patent 8168614*PED expires
Listed listed patent expiration.
Jul 20, 2030
in 4 yr 2 mo
Pharmaceutical detail
Active ingredient
CRISABOROLE
Strength
2%
Dosage form
OINTMENT
Route
TOPICAL
TE code
Not listed
Application
NDA 207695
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 (1)
- D-191New indication / change exclusivity (3 years)
Apr 03, 2026
3 mo ago
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8501712 | Feb 16, 2027 | in 8 mo | U-1932 |
| 9682092 | Feb 16, 2027 | in 8 mo | U-1932 |
| 8501712*PED | Aug 16, 2027 | in 1 yr 2 mo | |
| 9682092*PED | Aug 16, 2027 | in 1 yr 2 mo | |
| 8039451 | Jun 29, 2029 | in 3 yr 1 mo | SubstanceProduct |
| 8039451*PED | Dec 29, 2029 | in 3 yr 7 mo | |
| 8168614 | Jan 20, 2030 | in 3 yr 8 mo | U-1932 |
| 8168614*PED | Jul 20, 2030 | in 4 yr 2 mo |
