TIVICAY (dolutegravir sodium) · VIIV HLTHCARE
TIVICAY (dolutegravir sodium) is an antiretroviral medication indicated for the treatment of HIV-1 infection in adult and pediatric populations. It is used in combination with other antiretroviral agents for treatment-naïve or treatment-experienced adults and pediatric patients weighing at least 3 kg and aged at least 4 weeks. The drug is also indicated for use with rilpivirine as a complete regimen for virologically suppressed adults who have been on a stable antiretroviral regimen for at least 6 months. This combination therapy is intended for patients with no history of treatment failure or known resistance to either dolutegravir or rilpivirine.
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.
VIIV HLTHCARE's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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 and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg [see Microbiology ]. TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of 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...
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.