TIVICAY (dolutegravir sodium)
TIVICAY is indicated for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) in combination with other antiretroviral agents.; HIV-1 infection in pediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least 4 weeks and weighing at least 3 kg in.
How TIVICAY Works
Dolutegravir is an HIV-1 antiretroviral agent. It functions specifically as an HIV-1 integrase strand transfer inhibitor (INSTI). The medication is used as a component of combination antiretroviral therapy to manage HIV-1 infection.
Details
- Status
- Discontinued
- First Approved
- 2013-08-12
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- TABLET
TIVICAY Approval History
What TIVICAY Treats
2 indicationsTIVICAY is approved for 2 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 infection in adults (treatment-naïve or -experienced) in combination with other antiretroviral agents.
- HIV-1 infection in pediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least 4 weeks and weighing at least 3 kg in
TIVICAY 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.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02486133 Dualis | DUA-1463-SPI-0320-I | Ph 3 | completed | Dual Therapy With Boosted Darunavir + Dolutegravir |
| NCT03094507 SSAT073 | SSAT073 | Ph 1 | completed | The Pharmacokinetics of Dolutegravir, Darunavir/Cobocistat When Co-administered in Healthy Volunteers |
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.
TIVICAY FDA Label Details
Indications & Usage
FDA Label (PDF)TIVICAY is indicated for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) in combination with other antiretroviral agents.; HIV-1 infection in pediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least 4 weeks and weighing at least 3 kg in.
TIVICAY Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for TIVICAY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 36 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • 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.