ISENTRESS HD (raltegravir potassium) · Merck
ISENTRESS HD is FDA-approved to treat 1 condition (same as ISENTRESS).
Details
- Status
- Prescription
- First Approved
- 2007-10-12
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
ISENTRESS HD Approval History
What ISENTRESS HD Treats
1 indicationsISENTRESS HD is approved for 1 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as ISENTRESS (same active ingredient).
Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01022476 LIVERAL | ANRS 148 LIVERAL 2009-014616-36 | Ph 1, Ph 2 | completed | Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients |
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.
ISENTRESS HD FDA Label Details
Indications & Usage
FDA Label (PDF)ISENTRESS HD is FDA-approved to treat 1 condition — same approved indications as ISENTRESS.
ISENTRESS HD Patents & Exclusivity
Patents (7 active)
Pro Intelligence Preview
Deep insights for ISENTRESS HD
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 10 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.