Data updated: Mar 10, 2026
VIEKIRA XR
DASABUVIR SODIUM
Approved 2016-07-22
1
Indication
--
Phase 3 Trials
9
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2016-07-22
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
Website: ↗
VIEKIRA XR Approval History
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What VIEKIRA XR Treats
1 FDA approvalsOriginally approved for its first indication in 2016 .
- Other (1)
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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.
VIEKIRA XR FDA Label Details
ProVIEKIRA XR Patents & Exclusivity
Latest Patent: Jan 2035
Patents (18 active)
US9333204
Expires Jan 2, 2035
US9744170
Expires Jan 2, 2035
US10105365
Expires Jan 2, 2035
US8466159
Expires Sep 4, 2032
US8685984
Expires Sep 4, 2032
US8680106
Expires Sep 4, 2032
US8492386
Expires Sep 4, 2032
US10201584
Expires May 17, 2032
US10201541
Expires May 17, 2032
US8691938
Expires Apr 13, 2032
+ 8 more patents
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.