TheraRadar
Data updated: May 26, 2026

Dengvaxia (dengue tetravalent vaccine, live)

Approved 2019-04-30
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2019-04-30
Patent Cliff
2031

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Patent cliff and revenue data

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Routes
Subcutaneous
Dosage Forms
For Injection

Companies

Sanofi
Active Ingredient: Dengue Tetravalent Vaccine, Live

Dengvaxia Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2019 to 2019
Apr 2019 ORIGINAL
Update · CBER biologic (Purple Book)

What Dengvaxia Treats

1 FDA approvals

Originally approved for its first indication in 2019 .

  • 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.

Dengvaxia FDA Label Details

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Data Sources

FDA Approval: BLA125682 → Trials: ClinicalTrials.gov →

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