Data updated: May 26, 2026
AEMCOLO (rifamycin sodium)
Priority Review Fast Track
Infectious Disease
Approved 2018-11-16
1
Indication
--
Phase 3 Trials
1
Priority Reviews
7
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-11-16
- Patent Cliff
- 2028
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE
AEMCOLO Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2018 to 2019
What AEMCOLO Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
🔬
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.
AEMCOLO FDA Label Details
AEMCOLO Patents & Exclusivity
Exclusivity: Nov 2028
Exclusivity
NCE
Until Nov 2023
GAIN
Until Nov 2028
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.