HALDOL
LOE ApproachingNDAINJECTIONINJECTABLE
Approved
May 1971
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
HALDOL by Johnson & Johnson is unclear. Approved for schizophrenia in adults. First approved in 1971.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HALDOL (haloperidol) is a first-generation antipsychotic administered via injection for the treatment of schizophrenia in adults. It works primarily as a dopamine D2 receptor antagonist in the central nervous system, with secondary activity at alpha-1 adrenergic receptors. The drug's mechanism is believed to reduce dopaminergic hyperactivity associated with psychotic symptoms.
LOE Approaching
As LOE approaches and competitive pressure remains moderate (30%), the HALDOL franchise faces revenue headwinds that will likely constrain field team expansion and shift focus toward cost management and niche positioning.
Mechanism of Action
unclear. However, its effect in schizophrenia could be mediated through its activity as an antagonist at central dopamine type 2 receptors. Haloperidol also binds to alpha-1 adrenergic receptors, but with lower affinity, and displays minimal binding to muscarinic cholinergic and histaminergic (H 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.