Data updated: Mar 10, 2026
VIEKIRA PAK (COPACKAGED)
DASABUVIR SODIUM
Approved 2014-12-19
2
Indications
--
Phase 3 Trials
2
Priority Reviews
11
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2014-12-19
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
Website: ↗
VIEKIRA PAK (COPACKAGED) Approval History
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What VIEKIRA PAK (COPACKAGED) Treats
2 FDA approvalsOriginally approved for its first indication in 2014 . Covers 2 distinct patient populations.
- Other (2)
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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 PAK (COPACKAGED) FDA Label Details
ProVIEKIRA PAK (COPACKAGED) Patents & Exclusivity
Latest Patent: Oct 2033
Patents (15 active)
US9629841
Expires Oct 18, 2033
US10201542
Expires Oct 18, 2033
US8466159
Expires Sep 4, 2032
US8680106
Expires Sep 4, 2032
US8685984
Expires Sep 4, 2032
US8492386
Expires Sep 4, 2032
US8691938
Expires Apr 13, 2032
US8686026
Expires Jun 9, 2031
US9044480
Expires Apr 10, 2031
US8420596
Expires Apr 10, 2031
+ 5 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.