TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ACTHAR GEL (AUTOINJECTOR)

CORTICOTROPIN
Metabolic Approved 1952-04-29
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
73
Years on Market

Details

Status
Prescription
First Approved
1952-04-29
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

MALLINCKRODT IRELAND
Active Ingredient: CORTICOTROPIN

ACTHAR GEL (AUTOINJECTOR) Approval History

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What ACTHAR GEL (AUTOINJECTOR) Treats

1 FDA approvals

Originally approved for its first indication in 1952 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

ACTHAR GEL (AUTOINJECTOR) FDA Label Details

Pro

Indications & 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

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Data Sources

FDA Approval: NDA008372 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.