Data updated: Nov 8, 2026
Gammagard Liquid (immune globulin infusion (human)) · Takeda
Approved 2005-04-27
1
Indication
--
Phase 3 Trials
21
Years on Market
Details
- Status
- Prescription
- First Approved
- 2005-04-27
- Patent Cliff
- 2019
- Revenue
- $1.3B (Q2-FY2026) combined: Gammagard + HyQvia + Cuvitru
- Routes
- Intravenous, Subcutaneous
- Dosage Forms
- Injection
Gammagard Liquid Approval History
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 2005 to 2005
Apr 2005 ORIGINAL
Update · CBER biologic (Purple Book)
What Gammagard Liquid Treats
1 FDA approvalsOriginally approved for its first indication in 2005 .
- Other (1)
Other
(1 approval)- • Approved indication (Apr 2005)
Takeda's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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.
Gammagard Liquid FDA Label Details
Pro Intelligence Preview
Deep insights for Gammagard Liquid
Revenue Insights
- • Q2-FY2026: $1.3B (combined: Gammagard + HyQvia + Cuvitru)
- • Historical trend analysis
Patent Timeline
- • Cliff: 2019
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.