TheraRadar
Data updated: May 26, 2026

Alprolix (coagulation factor ix (recombinant), fc fusion protein)

Approved 2014-03-27
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
12
Years on Market

Details

Status
Prescription
First Approved
2014-03-27
Patent Cliff
2021
Revenue
$165M (Q4-2025)

Pro Metrics

Patent cliff and revenue data

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Routes
Intravenous
Dosage Forms
For Injection

Companies

Sanofi
Active Ingredient: Coagulation Factor IX (Recombinant), Fc Fusion Protein , Coagulation Factor IX (Recombinant), Fc Fusion Protein , Coagulation Factor IX (Recombinant), Fc Fusion Protein , Coagulation Factor IX (Recombinant), Fc Fusion Protein , Coagulation Factor IX (Recombinant), Fc Fusion Protein , Coagulation Factor IX (Recombinant), Fc Fusion Protein

Alprolix Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2014 to 2014
Mar 2014 ORIGINAL
Update · CBER biologic (Purple Book)

What Alprolix Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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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.

Alprolix FDA Label Details

Pro Intelligence Preview

Deep insights for Alprolix

Revenue Insights

  • • Q4-2025: $165M
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2021
  • • 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: BLA125444 → Trials: ClinicalTrials.gov →

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