NDAORALTABLET2 Generics Approved
Approved
Nov 2002
Lifecycle
LOE Approaching
Competitive Pressure
55/100
Clinical Trials
20
Data completeness
6/8 — Strong
ABILIFY (aripiprazole) by Otsuka. Approved for atypical antipsychotic [epc]. First approved in 2002.
Drug data last refreshed 21h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ABILIFY (aripiprazole) is an oral atypical antipsychotic tablet approved in 2002 for treating schizophrenia, bipolar disorder, and major depressive disorder as an adjunct. It works as a dopamine–serotonin system stabilizer with partial D2 receptor agonist activity. The drug has become a cornerstone therapy in psychiatry with extensive off-label use across multiple indications.
$0.012BPart D
LOE ApproachingDeclining
5mo to LOEProduct approaching loss of exclusivity in March 2027 with moderate competitive pressure (55/100); brand team will transition from revenue defense to managed decline and adjunctive positioning.
Mechanism of Action
Pharmacologic Class:
Atypical Antipsychotic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Double-Blind, Randomized Comparative Study of Carliprazine and Aripiprazole in Patients with Acute Schizophrenia
Started Oct 2024
376 enrolled
Acute Schizophrenia
Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)
Started Nov 2021
200 enrolled
SchizophreniaSchizo Affective DisorderBipolar I Disorder
Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)
Started Apr 2021
535 enrolled
Bipolar Disorder I
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
Started Dec 2019
15 enrolled
SchizophreniaSchizoaffective Disorder, Depressive TypeSchizophreniform Disorder
A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder
Started Aug 2019
266 enrolled
SchizophreniaBipolar I Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.