EVOTAZ (atazanavir sulfate)
EVOTAZ is a fixed-dose combination of atazanavir, an HIV-1 protease inhibitor, and cobicistat, a CYP3A inhibitor. It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg. In treatment-experienced patients, the use of EVOTAZ should be guided by the number of baseline primary protease inhibitor resistance substitutions.
How EVOTAZ Works
EVOTAZ functions through the synergistic action of two components. Atazanavir is an HIV-1 protease inhibitor that binds to the protease active site, preventing the cleavage of viral Gag-Pol polyproteins; this results in the production of immature, non-infectious viral particles. Cobicistat is a mechanism-based inhibitor of cytochrome P450 3A (CYP3A) enzymes. It has no antiviral activity but serves as a pharmacokinetic enhancer ("booster") to increase the systemic exposure and half-life of atazanavir.
Details
- Status
- Prescription
- First Approved
- 2015-01-29
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
EVOTAZ Approval History
What EVOTAZ Treats
1 indicationsEVOTAZ is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
EVOTAZ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 EVOTAZ
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02589158 | SSAT067 | Ph 1 | completed | SSAT067 PK of Atazanavir/Cobicistat and Darunavir/Cobicistat |
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.
EVOTAZ FDA Label Details
Indications & Usage
FDA Label (PDF)EVOTAZ is indicated for the treatment of HIV-1 Infection.
EVOTAZ Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for EVOTAZ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 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.