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AboutPricing
Drug ReportsAripiprazole
Abilify(aripiprazole)
Abilify, Aripiprazole, Opipza (aripiprazole) is a small molecule pharmaceutical. Aripiprazole was first approved as Abilify on 2002-11-15. It is used to treat schizophrenia and schizophrenia spectrum and other psychotic disorders in the USA. It has been approved in Europe to treat bipolar disorder and schizophrenia. The pharmaceutical is active against D(2) dopamine receptor. In addition, it is known to target 5-hydroxytryptamine receptor 1B, D(4) dopamine receptor, 5-hydroxytryptamine receptor 7, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 1D, histamine H1 receptor, 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 2C, and 5-hydroxytryptamine receptor 1A.
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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Abilify, Abilify asimtufii, Aripiprazole, Opipza (discontinued: Abilify, Aripiprazole)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Aripiprazole
Tradename
Company
Number
Date
Products
ABILIFY ASIMTUFIIOtsukaN-217006 RX2023-04-27
2 products, RLD, RS
ABILIFYOtsukaN-021436 RX2002-11-15
6 products, RLD
ABILIFY MAINTENA KITOtsukaN-202971 RX2013-02-28
4 products, RLD, RS
OPIPZAXiamen LP PharmaceuticalN-216655 RX2024-07-22
3 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
abilifyNew Drug Application2025-01-29
abilify abilifyNew Drug Application2013-08-13
abilify abilify discmelt2008-08-28
abilify asimtufiiNew Drug Application2025-04-04
abilify maintenaNew Drug Application2025-04-15
abilify maintena kitNew Drug Application2013-04-02
abilify myciteNew Drug Application2025-01-31
aripiprazoleANDA2025-08-12
aripiprazole oral solutionANDA2016-08-31
aristadaNew Drug Application2025-01-28
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
schizophreniaEFO_0000692D012559F20
schizophrenia spectrum and other psychotic disorders—D019967—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Aripiprazole, Abilify Maintena Kit, Otsuka Pharm Co Ltd
116483472034-04-06DP
105250572034-03-08U-543, U-1632, U-2723
109808032033-09-24U-543, U-1632
111545532033-09-24U-814, U-1632, U-3245
113445472033-09-24U-814, U-1632, U-3245
114000872033-09-24U-814, U-1632, U-3245
78076802024-10-19DP
80303132024-10-19U-543, U-1632
87226792024-10-19DP
Aripiprazole, Abilify Mycite Kit, Otsuka
92689092033-10-15DPU-2168
105175072032-06-13DP
93204552031-12-15DP
112293782031-07-11DP
85472482030-12-18DPU-2167
82589622030-11-25DP
89614122030-11-17DP
99419312030-11-04DP
114644232030-09-15DP
81140212030-06-21DP
85454022030-04-27DP
88477662030-03-29DPU-2167
91495772029-12-15DP
87181932029-12-05DP
94333712029-09-15DP
89450052029-08-19DPU-2167
104411942029-07-26DP
89562882029-07-06DPU-2167
86748252029-04-09DPU-2170
90607082029-03-05DP
92580352029-03-05DP
91195542028-12-16DP
94445032027-11-19DPU-2169
79780642026-09-14DP
114769522026-04-28DP
Aripiprazole, Abilify Asimtufii, Otsuka
105179512033-04-23DPU-814, U-3245
110970072033-04-23DPU-814, U-3245
116387572033-04-23DPU-814, U-3245
83994692025-06-29DP
83384272025-03-15DPU-543, U-1530, U-1633
83384282023-08-06DPU-543, U-1530, U-1633
87593512023-08-06DPU-1530, U-1633
Aripiprazole, Abilify, Otsuka
87593502027-03-02U-1529
91259392026-07-28U-1749
71155872024-07-21DPU-764
75504452024-07-21DP
80176152024-06-16DP
93871822023-12-25U-1529
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05A: Antipsychotics
— N05AX: Other antipsychotics in atc
— N05AX12: Aripiprazole
HCPCS
Code
Description
J0400
Injection, aripiprazole, intramuscular, 0.25 mg
J0401
Injection, aripiprazole, extended release, 1 mg
J1943
Injection, aripiprazole lauroxil, (aristada initio), 1 mg
J1944
Injection, aripiprazole lauroxil, (aristada), 1 mg
Clinical
Clinical Trials
452 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F20———112
Psychotic disordersD011618—F20.81———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Metabolic syndromeD024821EFO_0000195E88.810————11
SyndromeD013577——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAripiprazole
INNaripiprazole
Description
Aripiprazole is an N-arylpiperazine that is piperazine substituted by a 4-[(2-oxo-1,2,3,4-tetrahydroquinolin-7-yl)oxy]butyl group at position 1 and by a 2,3-dichlorophenyl group at position 4. It is an antipsychotic drug used for the treatment of Schizophrenia, and other mood disorders. It has a role as a H1-receptor antagonist, a serotonergic agonist, a second generation antipsychotic and a drug metabolite. It is a quinolone, a N-arylpiperazine, a N-alkylpiperazine, a dichlorobenzene, an aromatic ether and a delta-lactam.
Classification
Small molecule
Drug classantiulcer agents (benzimidazole derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Identifiers
PDB—
CAS-ID129722-12-9
RxCUI—
ChEMBL IDCHEMBL1112
ChEBI ID31236
PubChem CID60795
DrugBankDB01238
UNII ID82VFR53I78 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Abilify – Bristol Myers Squibb
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Aristada – Alkermes
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Tabular view
Estimated US medical usage
Aripiprazole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,888 documents
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Safety
Black-box Warning
Black-box warning for: Abilify, Abilify abilify, Abilify abilify discmelt, Abilify asimtufii, Abilify maintena, Abilify mycite, Aripiprazole, Aripiprazole oral solution, Aristada, Aristada initio, Opipza
Adverse Events
Top Adverse Reactions
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94,139 adverse events reported
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