TheraRadar
Data updated: May 26, 2026

VITEKTA (elvitegravir)

Infectious Disease Approved 2014-09-24
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Discontinued
First Approved
2014-09-24
Patent Cliff
2027

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

Gilead Sciences
Active Ingredient: ELVITEGRAVIR

VITEKTA Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2014 to 2016
Jan 2016 SUPPL
Mfg · Manufacturing (CMC)
Jul 2015 SUPPL
Label · Labeling
FDA Letter Label
Jul 2015 SUPPL
Mfg · Manufacturing (CMC)

What VITEKTA Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT00708162 results posted GS-US-183-0145 2007-004225-26 Ph 3 completed Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir
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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.

VITEKTA FDA Label Details

View full patent landscape →
6 OB patents · 2 families · 147 international docs across 39 countries

VITEKTA Patents & Exclusivity

Latest Patent: Apr 2027

Patents (6 active)

US7635704*PED Expires Apr 26, 2027
US8981103*PED Expires Apr 26, 2027
US7176220*PED Expires Feb 27, 2027
US7635704 Expires Oct 26, 2026
US8981103 Expires Oct 26, 2026
US7176220 Expires Aug 27, 2026
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2027
  • • 24 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA203093 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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