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HALDOL

NDA

HALOPERIDOL LACTATE | N015922 | ORTHO MCNEIL PHARMACEUTICAL

1 strength0 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 Lactate* (2023)

Total Spending

$1.9M

Total Claims

73,453

Beneficiaries

35,038

Avg Cost/Unit

$1.28

Spending Trend

$2.8M(2019)→$2.5M(2020)→$1.9M(2021)→$1.9M(2022)→$1.9M(2023)

YoY Change:+8.5%

5yr CAGR:+13.3%

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 (2023)

Total Spending

$624.75

Total Claims

212

Beneficiaries

112

ASP Price

—

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

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

Products (1)

#001 — EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CONCENTRATE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.