TheraRadar
Data updated: Jun 28, 2026

EPANED KIT (enalapril maleate) · AZURITY

Cardiovascular Approved 2013-08-13

EPANED KIT is FDA-approved to treat 3 conditions (same as ENALAPRIL MALEATE).

2
Indications
--
Phase 3 Trials
12
Years on Market

Details

Status
Discontinued
First Approved
2013-08-13
Patent Cliff
2032

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Routes
ORAL
Dosage Forms
FOR SOLUTION

Companies

Active Ingredient: ENALAPRIL MALEATE

EPANED KIT Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2013 to 2017 · 1 indication expansions
Jul 2017 SUPPL
Label · Labeling
Mar 2017 SUPPL
Label · Labeling
Jan 2016 SUPPL
Label · Labeling

What EPANED KIT Treats

3 indications

EPANED KIT is approved for 3 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as ENALAPRIL MALEATE (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT03466333 PICk-UP R04725 Ph 2 completed Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
NCT03667131 EEVA Ph 2 completed Enalapril Maleate on Arterial Stiffness in Rheumatoid Arthritis.
NCT01871740 CSPPT-CKD Ausa-CSPPT-CKD Ph 4 withdrawn CSPPT- Chronic Kidney Diseases Study
NCT00794885 CSPPT Ausa-CSPPT Ph 4 completed China Stroke Primary Prevention Trial
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Active Pipeline

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Ongoing clinical trials by development phase

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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.

EPANED KIT FDA Label Details

Indications & Usage

FDA Label (PDF)

EPANED KIT is FDA-approved to treat 3 conditions — same approved indications as ENALAPRIL MALEATE.

View full patent landscape →
4 OB patents · 1 families · 15 international docs across 6 countries

EPANED KIT Patents & Exclusivity

Latest Patent: Nov 2032

Patents (4 active)

US8778366 Expires Nov 6, 2032
US9968553 Expires Nov 6, 2032
US8568747 Expires Nov 6, 2032
US9855214 Expires Nov 6, 2032
Source: FDA Orange Book

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Revenue Insights

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  • Historical trend analysis

Patent Timeline

  • Cliff: 2032
  • 12 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • Competitor tracking
  • 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.