Orange Book product · Brand (NDA)
ANZUPGO
DELGOCITINIB
Brand (NDA)NDA 219155RX LEO PHARMA AS
At a glance
Jul 23, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 23, 2025
11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jul 23, 2030
in 4 yr 2 mo
Patent 8609647 expires
Listed drug substance patent expiration.
Sep 19, 2031
in 5 yr 4 mo
Pharmaceutical detail
Active ingredient
DELGOCITINIB
Strength
2%
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 219155
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)
Jul 23, 2030
in 4 yr 2 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8609647 | Sep 19, 2031 | in 5 yr 4 mo | SubstanceProductU-4237 |
