TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

VEKLURY

REMDESIVIR
Approved 2020-10-22
Jump to: Indications Approvals Trials Competitors Safety Patents
5
Indications
--
Phase 3 Trials
5
Priority Reviews
5
Years on Market

Details

Status
Discontinued
First Approved
2020-10-22
Routes
INTRAVENOUS
Dosage Forms
SOLUTION, POWDER

Companies

Gilead Sciences
Active Ingredient: REMDESIVIR

VEKLURY Approval History

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What VEKLURY Treats

5 FDA approvals

Originally approved for its first indication in 2020 . Covers 5 distinct patient populations.

  • Other (5)
🔬

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.

VEKLURY FDA Label Details

Pro

VEKLURY Patents & Exclusivity

Latest Patent: Nov 2041
Exclusivity: Jan 2027

Patents (142 active)

US11491169*PED Expires Nov 28, 2041
US11903953*PED Expires Nov 28, 2041
US11975012*PED Expires Nov 28, 2041
US11975012 Expires May 28, 2041
US11903953 Expires May 28, 2041
US11491169 Expires May 28, 2041
US10675296*PED Expires Jan 10, 2039
US11266681*PED Expires Jan 10, 2039
US11975017*PED Expires Jan 10, 2039
US11266681 Expires Jul 10, 2038
+ 132 more patents

Exclusivity

M-301 Until Jul 2026
NCE Until Oct 2025
M-301 Until Jul 2026
NCE Until Oct 2025
PED Until Apr 2026
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA214787 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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