NDAORALCONCENTRATEPriority Review
Approved
Apr 1967
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
HALDOL (haloperidol lactate) by Johnson & Johnson is clinical pharmacology haloperidol is an antipsychotic. Approved for schizophrenia. First approved in 1967.
Drug data last refreshed 8h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HALDOL (haloperidol lactate) is a first-generation antipsychotic approved in 1967 for schizophrenia treatment. It works as a dopamine D2 receptor antagonist in the central nervous system, with minimal activity at other receptor types. The oral concentrate formulation allows flexible dosing for acute and maintenance psychotic disorder management.
LOE Approaching
As a legacy antipsychotic approaching loss of exclusivity with moderate competitive pressure (30/100), brand teams are likely consolidating and shifting toward lifecycle management and generic transition planning.
Mechanism of Action
CLINICAL PHARMACOLOGY Haloperidol is an antipsychotic. The mechanism of action of haloperidol for the treatment of schizophrenia is unclear. However, its efficacy could be mediated through its activity as an antagonist at central dopamine type 2 receptors. Haloperidol also binds to alpha-1…
Indications (1)
Clinical Trials (2)
Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the ED: A RCT
Started Jun 2013
0Migraine HeadachesNauseaRestlessness
To Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal Volunteers
Started Apr 1987
30 enrolled
Psychosis
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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.