TheraRadar
Data updated: May 26, 2026

VIEKIRA PAK (COPACKAGED) (dasabuvir sodium)

Infectious Disease Approved 2014-12-19
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
2
Priority Reviews
11
Years on Market

Details

Status
Discontinued
First Approved
2014-12-19
Patent Cliff
2033

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

AbbVie
Active Ingredient: DASABUVIR SODIUM , OMBITASVIR, PARITAPREVIR, RITONAVIR

VIEKIRA PAK (COPACKAGED) Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
19 FDA actions from 2014 to 2019 · 1 indication expansions
Dec 2019 SUPPL
Label · Labeling
FDA Letter Label
Jul 2018 SUPPL
Label · Labeling
FDA Letter Label
Nov 2017 SUPPL
Label · Labeling
FDA Letter Label

What VIEKIRA PAK (COPACKAGED) Treats

2 FDA approvals

Originally approved for its first indication in 2014 . Covers 2 distinct patient populations.

  • Other (2)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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

View full patent landscape →
15 OB patents · 8 families · 465 international docs across 50 countries

VIEKIRA 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
US9006387 Expires Jun 10, 2030
US8642538 Expires Sep 10, 2029
US8188104 Expires May 17, 2029
US8501238 Expires Dec 19, 2028
US9139536 Expires Nov 9, 2028
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for VIEKIRA PAK (COPACKAGED)

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2033
  • • 15 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA206619 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.