Data updated: Nov 8, 2026
Cuvitru (immune globulin subcutaneous (human), 20% solution) · Takeda
Approved 2016-09-13
1
Indication
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Prescription
- First Approved
- 2016-09-13
- Revenue
- $1.3B (Q2-FY2026) combined: Gammagard + HyQvia + Cuvitru
- Routes
- Subcutaneous
- Dosage Forms
- Injection
Companies
Active Ingredient: Immune Globulin Subcutaneous (Human), 20% Solution , Immune Globulin Subcutaneous (Human), 20% Solution , Immune Globulin Subcutaneous (Human), 20% Solution , Immune Globulin Subcutaneous (Human), 20% Solution , Immune Globulin Subcutaneous (Human), 20% Solution
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Cuvitru Approval History
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2016 to 2016
Sep 2016 ORIGINAL
Update · CBER biologic (Purple Book)
What Cuvitru Treats
1 FDA approvalsOriginally approved for its first indication in 2016 .
- Other (1)
Other
(1 approval)- • Approved indication (Sep 2016)
Takeda's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03116347 results posted | 161504 2016-003438-26 | Ph 4 | completed | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects |
| NCT01218438 results posted | 170904 | Ph 2, Ph 3 | completed | Phase 2/3 Study of IGSC, 20% in PIDD |
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Pro Active Pipeline
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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.
Cuvitru FDA Label Details
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Deep insights for Cuvitru
Revenue Insights
- • Q2-FY2026: $1.3B (combined: Gammagard + HyQvia + Cuvitru)
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.