Data updated: Mar 10, 2026
ISENTRESS HD
RALTEGRAVIR POTASSIUM
Approved 2007-10-12
13
Indications
--
Phase 3 Trials
4
Priority Reviews
18
Years on Market
Details
- Status
- Prescription
- First Approved
- 2007-10-12
- Routes
- ORAL
- Dosage Forms
- TABLET
ISENTRESS HD Approval History
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What ISENTRESS HD Treats
13 FDA approvalsOriginally approved for its first indication in 2007 . Covers 13 distinct patient populations.
- Other (13)
Other
(13 approvals)- • Approved indication (Oct 2007) PriorityLabel Letter
- • Approved indication (Jan 2009)Label Letter
- • Approved indication (Jul 2009)Label Letter
- • Approved indication (Jun 2010)Label Letter
- • Approved indication (Dec 2011) PriorityLabel Letter
- • Approved indication (Mar 2012)Label Letter
- • Approved indication (Apr 2012)Label Letter
- • Approved indication (Jun 2013)Label Letter
- • Approved indication (Dec 2013) PriorityLabel Letter
- • Approved indication (May 2017)Label Letter
- • Approved indication (Nov 2017) PriorityLabel Letter
- • Approved indication (Mar 2018)Label Letter
- • Approved indication (Jul 2020)Label Letter
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
ISENTRESS HD FDA Label Details
ProISENTRESS HD Patents & Exclusivity
Latest Patent: Mar 2032
Patents (10 active)
US10772888
Expires Mar 30, 2032
US9649311*PED
Expires Apr 21, 2031
US9649311
Expires Oct 21, 2030
US8771733
Expires Jun 2, 2030
US7754731*PED
Expires Sep 11, 2029
US7754731
Expires Mar 11, 2029
US8852632
Expires Jan 28, 2028
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.