Data updated: May 26, 2026
EPANED KIT (enalapril maleate)
Cardiovascular
Approved 2013-08-13
2
Indications
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2013-08-13
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
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
Dec 2015 SUPPL
Mfg
Feb 2014 SUPPL
Mfg
What EPANED KIT Treats
2 FDA approvalsOriginally approved for its first indication in 2013 . Covers 2 distinct patient populations.
- Other (2)
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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| NCT01871740 CSPPT-CKD | Ausa-CSPPT-CKD | Ph 4 | withdrawn | CSPPT- Chronic Kidney Diseases Study |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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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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
View full patent landscape →
4 OB patents · 1 families ·
15 international docs across 6 countries
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Deep insights for EPANED KIT
Revenue Insights
- • Quarterly revenue tracking
- • 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.