TheraRadar
Data updated: May 26, 2026

OLYSIO (simeprevir sodium)

Infectious Disease Approved 2013-11-22
Jump to: Indications Approvals Trials Competitors Safety Patents
5
Indications
--
Phase 3 Trials
2
Priority Reviews
12
Years on Market

Details

Status
Discontinued
First Approved
2013-11-22
Patent Cliff
2029

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE

Companies

Johnson & Johnson
Active Ingredient: SIMEPREVIR SODIUM

OLYSIO Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 2013 to 2017 · 4 indication expansions
Nov 2017 SUPPL
Label · Labeling
FDA Letter Label
May 2017 SUPPL
Label · Labeling
FDA Letter Label
Feb 2017 SUPPL
Label · Labeling
FDA Letter Label

What OLYSIO Treats

5 FDA approvals

Originally approved for its first indication in 2013 . Covers 5 distinct patient populations.

  • Other (5)
🔬

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.

OLYSIO FDA Label Details

View full patent landscape →
8 OB patents · 1 families · 90 international docs across 41 countries

OLYSIO Patents & Exclusivity

Latest Patent: Sep 2029

Patents (8 active)

US8148399 Expires Sep 5, 2029
US8349869 Expires Jul 28, 2026
US8754106 Expires Jul 28, 2026
US8741926 Expires Jul 28, 2026
US9040562 Expires Jul 28, 2026
US9856265 Expires Jul 28, 2026
US9353103 Expires Jul 28, 2026
US9623022 Expires Jul 28, 2026
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 8 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: NDA205123 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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