TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ABILIFY

ARIPIPRAZOLE
Approved 2002-11-15
Jump to: Indications Approvals Trials Competitors Safety Patents
15
Indications
--
Phase 3 Trials
1
Priority Reviews
23
Years on Market

Details

Status
Discontinued
First Approved
2002-11-15
Routes
ORAL, INTRAMUSCULAR
Dosage Forms
SOLUTION, INJECTABLE, TABLET, TABLET, ORALLY DISINTEGRATING

Companies

OTSUKA
Active Ingredient: ARIPIPRAZOLE

ABILIFY Approval History

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What ABILIFY Treats

15 FDA approvals

Originally approved for its first indication in 2002 . Covers 15 distinct patient populations.

  • Other (15)
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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.

ABILIFY FDA Label Details

Pro

ABILIFY Patents & Exclusivity

Latest Patent: Mar 2027

Patents (89 active)

US8759350 Expires Mar 2, 2027
US9125939 Expires Jul 28, 2026
+ 79 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA021713 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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