Data updated: Mar 29, 2026
ACTHAR GEL (AUTOINJECTOR)
CORTICOTROPIN
Metabolic
Approved 1952-04-29
USES TAKE 15 MINUTES BEFORE MEALS...
Source: FDA Label • MALLINCKRODT IRELAND
1
Indication
--
Phase 3 Trials
73
Years on Market
Details
- Status
- Prescription
- First Approved
- 1952-04-29
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ACTHAR GEL (AUTOINJECTOR) Approval History
Loading approval history...
What ACTHAR GEL (AUTOINJECTOR) Treats
1 FDA approvalsOriginally approved for its first indication in 1952 .
- Other (1)
Other
(1 approval)- • Approved indication (Apr 1952)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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.
ACTHAR GEL (AUTOINJECTOR) FDA Label Details
ProIndications & Usage
FDA Label (PDF)USES TAKE 15 MINUTES BEFORE MEALS
ACTHAR GEL (AUTOINJECTOR) Patents & Exclusivity
Latest Patent: Jul 2041
Patents (18 active)
US11752199
Expires Jul 18, 2041
+ 8 more patents
Source: FDA Orange Book
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.