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Data updated: Mar 10, 2026

VOCABRIA

CABOTEGRAVIR SODIUM
Infectious Disease Approved 2021-01-21
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
7
Indications
--
Phase 3 Trials
4
Priority Reviews
5
Years on Market

Details

Status
Prescription
First Approved
2021-01-21
Routes
ORAL
Dosage Forms
TABLET

Companies

VIIV HLTHCARE
Active Ingredient: CABOTEGRAVIR SODIUM

VOCABRIA Approval History

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What VOCABRIA Treats

1 indications

VOCABRIA is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • HIV-1 Infection
Source: FDA Label

Drugs Similar to VOCABRIA

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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.

VOCABRIA FDA Label Details

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Indications & Usage

FDA Label (PDF)

HIV-1 Treatment: VOCABRIA is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with EDURANT (rilpivirine) for short-term treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. HIV-1 Pre-Exposure Prophylaxis: VOCABRIA is indicated for short-term pre-exposure prophylaxis (PrEP) to reduce the risk of sexuall...

VOCABRIA Patents & Exclusivity

Latest Patent: Feb 2031
Exclusivity: Jan 2026

Patents (2 active)

US8410103 Expires Feb 4, 2031
US10927129 Expires Apr 28, 2026

Exclusivity

NCE Until Jan 2026
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA212887 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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