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 8h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HALDOL (haloperidol) is a small-molecule antipsychotic approved in 1971 for treating schizophrenia in adults via injectable formulation. It works primarily as a dopamine D2 receptor antagonist in the central nervous system, with secondary activity at alpha-1 adrenergic receptors. The mechanism effectively reduces psychotic symptoms through dopaminergic modulation.
LOE Approaching
As LOE approaches with moderate competitive pressure (30), brand teams face contraction; focus shifts to niche positioning and retention of long-standing patient populations rather than market expansion.
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
Worked on HALDOL at Johnson & Johnson? Share your interview experience or compensation data (+7 days Pro)
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.