Orange Book product · Brand (NDA)
PICATO
INGENOL MEBUTATE
At a glance
Jan 23, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 23, 2012
14 yr 7 mo ago
Today
Patent 8372827 expires
Listed drug product patent expiration.
Dec 18, 2026
in 6 mo
Patent 8372828 expires
Listed drug product patent expiration.
Dec 18, 2026
in 6 mo
Patent 8377919 expires
Listed drug product patent expiration.
Dec 18, 2026
in 6 mo
Patent 8536163 expires
Listed method-of-use patent (U-1440) expiration.
Dec 18, 2026
in 6 mo
Patent 8716271 expires
Listed method-of-use patent (U-1440) expiration.
Dec 18, 2026
in 6 mo
Patent 8735375 expires
Listed method-of-use patent (U-1440) expiration.
Dec 18, 2026
in 6 mo
Patent 9820959 expires
Listed drug product patent expiration.
Dec 18, 2026
in 6 mo
Patent 9833428 expires
Listed drug product patent expiration.
Dec 18, 2026
in 6 mo
Patent 9833429 expires
Listed drug product patent expiration.
Dec 18, 2026
in 6 mo
Patent 9861603 expires
Listed method-of-use patent (U-1440) expiration.
Dec 18, 2026
in 6 mo
Patent 8278292 expires
Listed drug product patent expiration.
Jul 06, 2027
in 1 yr 1 mo
Pharmaceutical detail
Active ingredient
INGENOL MEBUTATE
Strength
0.05%
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
NDA 202833
Product number
002
Marketing status
DISCN
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.
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8372827 | Dec 18, 2026 | in 6 mo | Product |
| 8372828 | Dec 18, 2026 | in 6 mo | Product |
| 8377919 | Dec 18, 2026 | in 6 mo | Product |
| 8536163 | Dec 18, 2026 | in 6 mo | U-1440 |
| 8716271 | Dec 18, 2026 | in 6 mo | U-1440 |
| 8735375 | Dec 18, 2026 | in 6 mo | U-1440 |
| 9820959 | Dec 18, 2026 | in 6 mo | ProductU-1440 |
| 9833428 | Dec 18, 2026 | in 6 mo | Product |
| 9833429 | Dec 18, 2026 | in 6 mo | Product |
| 9861603 | Dec 18, 2026 | in 6 mo | U-1440 |
| 8278292 | Jul 06, 2027 | in 1 yr 1 mo | Product |
