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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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Haloperidol Decanoate 100 (2023)

Total Spending

$690K

Total Claims

11,189

Beneficiaries

2,269

Avg Cost/Unit

$38.05

Spending Trend

$59K(2019)→$6.7M(2019)→$10K(2019)→$4.4M(2020)→$37K(2020)→$8K(2020)→$14K(2021)→$4K(2021)→$2.1M(2021)→$1.1M(2022)→$11K(2022)→$6K(2022)→$2K(2023)→$690K(2023)→$5K(2023)

YoY Change:-9.5%

5yr CAGR:-3.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Haldol Decanoate 100 (2023)

Total Spending

$54K

Total Claims

3,755

Beneficiaries

704

ASP Price

—

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

Source: CMS Medicare Part B Spending by Drug (2023). 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)

Sort:

#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