JULUCA (dolutegravir sodium) · VIIV HLTHCARE
JULUCA is a fixed-dose combination therapy indicated as a complete regimen for the treatment of HIV-1 infection in adults. It is used to replace a current antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen for at least six months. Eligible patients must have no history of treatment
Details
- Status
- Prescription
- First Approved
- 2017-11-21
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
JULUCA Approval History
What JULUCA Treats
1 indicationsJULUCA is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
JULUCA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to JULUCA
3 of 12FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
VIIV HLTHCARE's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
JULUCA FDA Label Details
Indications & Usage
FDA Label (PDF)JULUCA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA. JULUCA, a two-drug combination of dolutegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcripta...
JULUCA Patents & Exclusivity
Patents (6 active)
Pro Intelligence Preview
Deep insights for JULUCA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 6 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 12 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.