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Treats Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive. Sold as Abilify, Abilify Maintena, Abilify Mycite, Mezofy, Opipza and 1 more. Every FDA application for this active ingredient: 9 branded and 42 generic.
As of Nov 15, 2026, FDA lists 51 applications for Aripiprazole (sold as Abilify, Abilify Maintena, Abilify Mycite and others), first approved Nov 15, 2002, with 43 new uses approved and 1 published complete response letter.
First approved: Nov 15, 2002
Applications: 51
New uses approved: 43
Complete response letters: 1
Medicare spending, 2025: $1.00B
First approved in the EU: Jun 4, 2004
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
ABILIFY Prolonged Release AqueousDrugs with a new indication for the prevention of recurrence/relapse of mood episodes in patients with bipolar I disorder. · Otsuka Pharmaceutical Co., Ltd. · Sep 25, 2020
Abilify, new approvalDrugs with a new additional indication, dosage, and dosage form for the treatment of irritability associated with autism spectrum disorder in children and… · Otsuka Pharmaceutical Co., Ltd. · Sep 28, 2016
AbilifyDrugs with a new additional indication and a new dosage for the treatment of depression (for use only in patients who have an inadequate response to… · Otsuka Pharmaceutical Co., Ltd. · Jun 14, 2013
[1] AbilifyDrugs with a new additional indication and a new dosage in new dosage forms for the improvement of manic symptoms in patients with bipolar disorder. · Otsuka Pharmaceutical Co., Ltd. · Jan 18, 2012
Clinical Trials
37 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
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