TheraRadar
Data updated: May 26, 2026

CLOROTEKAL (chloroprocaine hydrochloride)

Pain Approved 2017-09-26
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Discontinued
First Approved
2017-09-26
Patent Cliff
2033

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Routes
INTRATHECAL
Dosage Forms
SOLUTION

Companies

Active Ingredient: CHLOROPROCAINE HYDROCHLORIDE

CLOROTEKAL Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2017 to 2017
Sep 2017 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer

What CLOROTEKAL Treats

1 FDA approvals

Originally approved for its first indication in 2017 .

  • Other (1)
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CLOROTEKAL FDA Label Details

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2 OB patents · 2 families · 42 international docs across 28 countries

CLOROTEKAL Patents & Exclusivity

Latest Patent: Dec 2033

Patents (2 active)

US9504666 Expires Dec 11, 2033
US8969412 Expires Sep 5, 2026
Source: FDA Orange Book

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Revenue Insights

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  • Historical trend analysis

Patent Timeline

  • Cliff: 2033
  • 2 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

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  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.