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HALDOL

NDA

HALOPERIDOL | N015921 | ORTHO MCNEIL PHARMACEUTICAL

6 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Appco Pharma, LLC FDA-2026-P-4060 · 7 docket documents Appco Pharma LLC filed this suitability petition under section 505(j)(2)(C) of the FDC Act requesting FDA approval to submit an ANDA for Haloperidol Tablets USP in 0.25 mg and 2.5 mg strengths, which differ from the reference listed drug HALDOL (Haloperidol) tablets approved under NDA #015921 in 0.5	Suitability	2026-04-14	Open	Appco Pharma, LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

110 trials from ClinicalTrials.gov, 3 active, 75 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer NCT01949662	Phase 2	Active	M.D. Anderson Cancer Center	93	2014-01 → 2028-01-01
Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care NCT03743649	Phase 2/3	Active	M.D. Anderson Cancer Center	110	2019-07-17 → 2028-12-31
Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer NCT03021486	Phase 2/3	Active	M.D. Anderson Cancer Center	70	2017-06-05 → 2027-06-30
A 4-week, Randomized, Rater-blinded, Parallel Study to Evaluate Quetiapine in Improving Sleep Quality of Schizophrenia NCT00642369	N/A	Completed	Guang Dong Provincial Mental Health Institute	60	2008-03 → 2009-10
Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia NCT01164059	Phase 4	Completed	University of Bremen	149	2010-02 → 2014-03
Haloperidol vs. Valproate in Agitation NCT01750541	Phase 3	Completed	Shahid Beheshti University of Medical Sciences	56	2012-12 → 2013-01
Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia NCT00859872	Phase 4	Completed	Central South University	198	2008-08 → 2009-03
Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia NCT03075657	Phase 4	Completed	All India Institute of Medical Sciences, Bhubaneswar	120	2017-05-01 → 2018-08-31
Treatment of Behavioral Symptoms in Alzheimer's Disease NCT00009217	Phase 4	Completed	New York State Psychiatric Institute	44	1999-01 → 2004-12
Pre-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient NCT01501123	N/A	Completed	Catholic Health East	10	2011-11 → 2015-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part B Spending

CMS physician-administered drug spending for Haldol (2024)

Total Spending

$550.37

Total Claims

175

Beneficiaries

ASP Price

$1.22

Spending Trend

$811.32(2019)→$497.54(2020)→$535.59(2021)→$547.82(2022)→$624.75(2023)→$550.37(2024)

YoY Change:+5.5%

5yr CAGR:+10.6%

HCPCS: J1630 — Injection, haloperidol, up to 5 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain7 active DMFs6 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVHALOPERIDOL

DMF 49911983

JANSSEN PHARMACEUTICA NVHALOPERIDOL (R001625) DRUG SUBSTANCE

DMF 109461994

EXCELLA GMBH AND CO KGHALOPERIDOL

DMF 142261999

OLON SPAHALOPERIDOL

DMF 245852011

MSN LIFE SCIENCES PRIVATE LTDHALOPERIDOL USP

DMF 336922019

MANKIND PHARMA LTDHALOPERIDOL USP

DMF 341902019

VAMSI LABS LTDHALOPERIDOL USP

DMF 342832019

A NATTERMANN AND CIE GMBHInactiveHALOPERIDOL

DMF 53641984

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveHALOPERIDOL

DMF 62001986

IMHAUSEN CHEMIE GMBHInactiveHALOPERIDOL

DMF 68001987

GD SEARLE AND COInactiveHALOPERIDOL

DMF 71571987

HEUMANN PCS GMBHInactiveHALOPERIDOL

DMF 74861988

RPG LIFE SCIENCES LTDInactiveHALOPERIDOL USP

DMF 233112009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (6)

Sort:

#001 — 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴