TheraRadar
Data updated: Nov 8, 2026

Buminate, Flexbumin (albumin (human)) · Takeda

Approved 1954-03-03
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
72
Years on Market

Details

Status
Prescription
First Approved
1954-03-03
Revenue
$217M (Q2-FY2026) combined: Flexbumin + Buminate

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Routes
Intravenous
Dosage Forms
Injection

Companies

Takeda
Active Ingredient: Albumin (Human) , Albumin (Human) , Albumin (Human) , Albumin (Human) , Albumin (Human)

Buminate, Flexbumin Approval History

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Original
New Indication
New Form
Label Update
1 FDA actions from 1954 to 1954
Mar 1954 ORIGINAL
Update · CBER biologic (Purple Book)

What Buminate, Flexbumin Treats

1 FDA approvals

Originally approved for its first indication in 1954 .

  • Other (1)
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Active Pipeline

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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.

Buminate, Flexbumin FDA Label Details

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Deep insights for Buminate, Flexbumin

Revenue Insights

  • • Q2-FY2026: $217M (combined: Flexbumin + Buminate)
  • • Historical trend analysis

Patent Timeline

  • • Patent expiration dates
  • • 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: BLA101452 → Trials: ClinicalTrials.gov →

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