TIVICAY PD (dolutegravir sodium) · VIIV HLTHCARE
TRIUMEQ and TRIUMEQ PD are fixed-dose combination antiretroviral medications indicated for the treatment of HIV-1 infection. The therapy is approved for use in adults and pediatric patients who are at least 3 months of age and weigh at least 6 kg. These formulations are not recommended for individuals with resistance-associated integrase substitutions or suspected resistance to integrase strand transfer inhibitors due to dosage limitations.
How TIVICAY PD Works
This medication is a combination of three antiretroviral agents: dolutegravir, abacavir, and lamivudine. Dolutegravir functions as an integrase strand transfer inhibitor (INSTI), while abacavir and lamivudine act as nucleoside analogue reverse transcriptase inhibitors (NRTIs). These components work together to target and inhibit the biological mechanisms required for HIV-1 viral replication.
Details
- Status
- Prescription
- First Approved
- 2020-06-12
- Patent Cliff
- 2030
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
TIVICAY PD Approval History
What TIVICAY PD Treats
1 indicationsTIVICAY PD is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
TIVICAY PD Competitive Set
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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VIIV HLTHCARE's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Trial Timeline
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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 PD 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) weighing at least 2 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 stable antiretroviral reg...
TIVICAY PD Patents & Exclusivity
Patents (4 active)
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.