Data updated: Mar 10, 2026
PICATO
INGENOL MEBUTATE
Approved 2012-01-23
2
Indications
--
Phase 3 Trials
14
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2012-01-23
- Routes
- TOPICAL
- Dosage Forms
- GEL
PICATO Approval History
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What PICATO Treats
2 FDA approvalsOriginally approved for its first indication in 2012 . Covers 2 distinct patient populations.
- Other (2)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PICATO FDA Label Details
ProPICATO Patents & Exclusivity
Latest Patent: May 2033
Patents (46 active)
US9789078
Expires May 15, 2033
US8278292
Expires Jul 6, 2027
US8536163
Expires Dec 18, 2026
US8716271
Expires Dec 18, 2026
US9820959
Expires Dec 18, 2026
US8735375
Expires Dec 18, 2026
US9861603
Expires Dec 18, 2026
US9833429
Expires Dec 18, 2026
US8377919
Expires Dec 18, 2026
US8372827
Expires Dec 18, 2026
+ 36 more patents
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.