TheraRadar
Data updated: Mar 29, 2026

VANCOMYCIN

VANCOMYCIN
Approved 2021-08-26
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
4
Years on Market

Details

Status
Discontinued
First Approved
2021-08-26
Routes
INTRAVENOUS, ORAL
Dosage Forms
SOLUTION

Companies

Hikma
Active Ingredient: VANCOMYCIN

VANCOMYCIN Approval History

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What VANCOMYCIN Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

  • Other (1)
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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

ClinicalTrials.gov ↗ Pro

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.

VANCOMYCIN FDA Label Details

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VANCOMYCIN Patents & Exclusivity

Latest Patent: Nov 2035

Patents (5 active)

US11517609 Expires Nov 6, 2035
US10188697 Expires Nov 6, 2035
US10039804 Expires Nov 6, 2035
US10849956 Expires Nov 6, 2035
US11000567 Expires Nov 6, 2035
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA213895 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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