Data updated: May 26, 2026
PREPOPIK (citric acid)
Gastrointestinal
Approved 2012-07-16
2
Indications
--
Phase 3 Trials
13
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2012-07-16
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION
Companies
Website: ↗
PREPOPIK Approval History
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2012 to 2023 · 1 indication expansions
May 2016 SUPPL
Mfg · Manufacturing (CMC)
What PREPOPIK Treats
2 FDA approvalsOriginally approved for its first indication in 2012 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03769402 | 52-376 | Ph 4 | completed | The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile |
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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.
PREPOPIK FDA Label Details
View full patent landscape →
2 OB patents · 1 families ·
39 international docs across 24 countries
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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- • 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.