Orange Book product · Brand (NDA)
ADQUEY
DIFAMILAST
At a glance
Feb 12, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 12, 2026
4 mo ago
Today
Patent RE46792 expires
Listed drug substance patent expiration.
Mar 01, 2028
in 1 yr 9 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Feb 12, 2031
in 4 yr 9 mo
Patent 10588893 expires
Listed drug substance patent expiration.
Dec 31, 2036
in 10 yr 8 mo
Pharmaceutical detail
Active ingredient
DIFAMILAST
Strength
1%
Dosage form
OINTMENT
Route
TOPICAL
TE code
Not listed
Application
NDA 219474
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)
- NCENew chemical entity exclusivity (5 years)
Feb 12, 2031
in 4 yr 9 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE46792 | Mar 01, 2028 | in 1 yr 9 mo | SubstanceProductU-4445 |
| 10588893 | Dec 31, 2036 | in 10 yr 8 mo | SubstanceProduct |
