TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

TIVICAY

DOLUTEGRAVIR SODIUM
Approved 2013-08-12
Jump to: Indications Approvals Trials Competitors Safety Patents
8
Indications
--
Phase 3 Trials
3
Priority Reviews
12
Years on Market

Details

Status
Discontinued
First Approved
2013-08-12
Routes
ORAL
Dosage Forms
TABLET

Companies

VIIV HLTHCARE
Active Ingredient: DOLUTEGRAVIR SODIUM

TIVICAY Approval History

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What TIVICAY Treats

8 FDA approvals

Originally approved for its first indication in 2013 . Covers 8 distinct patient populations.

  • Other (8)
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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.

TIVICAY FDA Label Details

Pro

TIVICAY Patents & Exclusivity

Latest Patent: Jun 2030

Patents (36 active)

US9242986*PED Expires Jun 8, 2030
US9242986 Expires Dec 8, 2029
US8129385*PED Expires Apr 5, 2028
US8129385 Expires Oct 5, 2027
+ 26 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA204790 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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