Abilify
An oral or injectable medication used to treat schizophrenia, bipolar disorder, and major depression.
Where Aripiprazole is approved
All regulators →Of the three regulators tracked here, the first to approve Aripiprazole was the US, on 15 Nov 2002. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Aripiprazole patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Aripiprazole, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 14 listed patents; the last listed expires 15 Dec 2041 (US 11701352).
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Aripiprazole
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Aripiprazole works
All drug targets →- Dopamine D2 receptor partial agonist Partial agonistTarget: DRD2 dopamine receptor D2✓ In ChEMBL and the Guide to Pharmacology
- Serotonin 1a (5-HT1a) receptor partial agonist Partial agonistTarget: HTR1A 5-hydroxytryptamine receptor 1A✓ In ChEMBL and the Guide to Pharmacology
- Serotonin 2a (5-HT2a) receptor antagonist AntagonistTarget: HTR2A 5-hydroxytryptamine receptor 2A✓ In ChEMBL and the Guide to Pharmacology
- Alzheimer diseasePhase 3
- Alcohol dependencePhase 3
- Anorexia nervosaPhase 3
- Chronic tic disorderPhase 3
- DementiaPhase 3
- Major depressive episodePhase 3
- Pervasive developmental disorderPhase 3
- Post-traumatic stress disorderPhase 3
- Postpartum depressionPhase 3
- Schizoaffective disorderPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1112, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 34, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Aripiprazole
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Aripiprazole. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Aripiprazole for treating moderate to severe manic episodes in adolescents with bipolar I disorder NICE TA292 | Recommended | 24 Jul 2013 | Current |
| Aripiprazole for the treatment of schizophrenia in people aged 15 to 17 years NICE TA213 | Recommended | 26 Jan 2011 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Aripiprazole
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 55 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Abilify, Abilify Maintena, Aripiprazole Accord (generic), Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) (generic), Aripiprazole Sandoz (generic), Aripiprazole Zentiva (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Aripiprazole
- ATC code
- N05AX12
- ChEMBL
- CHEMBL1112
- DrugBank
- DB01238
- PubChem CID
- 60795
- CAS number
- 129722-12-9
- FDA UNII
- 82VFR53I78
- Wikidata
- Q411188
- Wikipedia
- Aripiprazole
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Abilify is used for
ABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder ABILIFY is an atypical antipsychotic. ABILIFY is indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's Disorder ( 14.5 )
How it works
12.1 Mechanism of Action The mechanism of action of aripiprazole in schizophrenia or bipolar mania, is unclear. However, the efficacy of aripiprazole in the listed indications could be mediated through a combination of partial agonist activity at D 2 and 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 5 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.