TheraRadar
Data updated: Sep 20, 2026

Octagam (immune globulin intravenous (human)) · Octapharma

Approved 2004-05-20
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2004-05-20
Patent Cliff
2028
Revenue
$138M (Q2-2026)

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Patent cliff and revenue data

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Routes
Intravenous
Dosage Forms
Injection

Companies

Octapharma
Active Ingredient: Immune Globulin Intravenous (Human) , Immune Globulin Intravenous (Human) , Immune Globulin Intravenous (Human) , Immune Globulin Intravenous (Human) , Immune Globulin Intravenous (Human) , Immune Globulin Intravenous (Human) , Immune Globulin Intravenous (Human) , Immune Globulin Intravenous (Human) , Immune Globulin Intravenous (Human)

Octagam Approval History

2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2004 to 2004
May 2004 ORIGINAL
Update · CBER biologic (Purple Book)

What Octagam Treats

1 FDA approvals

Originally approved for its first indication in 2004 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT05832034 TIMEISMUSCLE NL74270.018.20 Ph 2, Ph 3 active not recruiting Add-on Intravenous Immunoglobulins in Early Myositis
NCT04411667 results posted COVID-IVIG 2004902 Ph 4 completed Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
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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.

Octagam FDA Label Details

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Deep insights for Octagam

Revenue Insights

  • • Q2-2026: $138M
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2028
  • • Generic/biosimilar risk

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

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

FDA Approval: BLA125062 → Trials: ClinicalTrials.gov →

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