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HALDOL

NDA

HALOPERIDOL DECANOATE | N018701 | JANSSEN PHARMACEUTICALS INC

2 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

No FDA citizen petitions matched from Regulations.gov

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 D Spending

CMS annual spending data across 4 drug listings matched to this application (2024)

Haloperidol Decanoate (2024)

Total Spending

$15.2M

Total Claims

312,420

Beneficiaries

34,914

Avg Cost/Unit

$28.77

Spending Trend

$15.9M(2019)→$14.4M(2020)→$14.9M(2021)→$16.9M(2022)→$16.6M(2023)→$15.2M(2024)

YoY Change:-11.1%

5yr CAGR:-5.8%

Haloperidol Decanoate 100 (2024)

Total Spending

$230K

Total Claims

4,291

Beneficiaries

1,285

Avg Cost/Unit

$33.54

Spending Trend

$6.7M(2019)→$4.4M(2020)→$2.1M(2021)→$1.1M(2022)→$690K(2023)→$230K(2024)

YoY Change:-11.9%

5yr CAGR:-6.7%

Haldol Decanoate 100 (2024)

Total Spending

$4K

Total Claims

Beneficiaries

Avg Cost/Unit

$96.68

Spending Trend

$59K(2019)→$37K(2020)→$14K(2021)→$11K(2022)→$2K(2023)→$4K(2024)

YoY Change:+12.3%

5yr CAGR:-11.4%

Haldol Decanoate 50 (2024)

Total Spending

$4K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$78.47

Spending Trend

$10K(2019)→$8K(2020)→$4K(2021)→$6K(2022)→$5K(2023)→$4K(2024)

YoY Change:+9.2%

5yr CAGR:-2.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Haldol Decanoate 100 (2024)

Total Spending

$42K

Total Claims

3,095

Beneficiaries

584

ASP Price

$7.21

Spending Trend

$270K(2019)→$222K(2020)→$141K(2021)→$76K(2022)→$54K(2023)→$42K(2024)

YoY Change:-6.3%

5yr CAGR:-19.2%

HCPCS: J1631 — Injection, haloperidol decanoate, per 50 mg

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

API Supply Chain5 active DMFs2 inactive

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

JANSSEN PHARMACEUTICA NVHALOPERIDOL DECANOATE

DMF 109541994

TAPI NL BVHALOPERIDOL DECANOATE

DMF 125301997

OLON SPAHALOPERIDOL DECANOATE

DMF 169492003

MSN LIFE SCIENCES PRIVATE LTDHALOPERIDOL DECANOATE USP

DMF 337032019

MANKIND PHARMA LTDHALOPERIDOL DECANOATE USP

DMF 343532020

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANAInactiveHALOPERIDOL DECANOATE

DMF 66821986

EXCELLA GMBHInactiveHALOPERIDOL DECANOATE

DMF 191972006

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

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Nov 3, 2025	SUPPL -77	View Letter (PDF)
Feb 7, 2025	SUPPL -78	View Letter (PDF)
Nov 18, 2020	SUPPL -76	View Letter (PDF)
Nov 18, 2020	SUPPL -71	View Letter (PDF)
Mar 12, 2019	SUPPL -73	View Letter (PDF)
Dec 7, 2017	SUPPL -70	View Letter (PDF)
Mar 2, 2017	SUPPL -74	View Letter (PDF)
May 20, 2016	SUPPL -72	View Letter (PDF)
May 7, 2013	SUPPL -65	View Letter (PDF)
Aug 15, 2011	SUPPL -54	View Letter (PDF)
Mar 7, 2011	SUPPL -63	View Letter (PDF)
Dec 6, 2010	SUPPL -62	View Letter (PDF)
Aug 4, 2009	SUPPL -59	View Letter (PDF)
Aug 19, 2008	SUPPL -57	View Letter (PDF)
May 14, 2008	SUPPL -56	View Letter (PDF)
Sep 25, 2007	SUPPL -55	View Letter (PDF)
May 9, 2007	SUPPL -53	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 50MG BASE/ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 14, 1986

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 31, 1997