Data updated: Nov 8, 2026
Refacto (antihemophilic factor (recombinant)) · Pfizer
Approved 2001-06-27
1
Indication
--
Phase 3 Trials
25
Years on Market
Details
- Status
- Disc
- First Approved
- 2001-06-27
- Revenue
- $52M (Q4-2023) combined: ReFacto AF + Xyntha
- Routes
- Intravenous
- Dosage Forms
- For Injection
Companies
Active Ingredient: Antihemophilic Factor (Recombinant) , Antihemophilic Factor (Recombinant) , Antihemophilic Factor (Recombinant) , Antihemophilic Factor (Recombinant)
Website: ↗
Refacto Approval History
2002
2003
2004
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 2001 to 2001
Jun 2001 ORIGINAL
Update · CBER biologic (Purple Book)
What Refacto Treats
1 FDA approvalsOriginally approved for its first indication in 2001 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2001)
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2020 RIMEGEPANT SULFATE
VIZIMPRO
2018 DACOMITINIB
2 designations
DAURISMO
2018 GLASDEGIB MALEATE
2 designations
TALZENNA
2018 TALAZOPARIB TOSYLATE
1 designation
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02932618 | 071102 2016-001477-33, 2023-509769-18-00 | Ph 3 | completed | A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD) |
| NCT02973087 results posted | 071301 2016-001478-14 | Ph 3 | completed | rVWF IN PROPHYLAXIS |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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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.
Refacto FDA Label Details
Pro Intelligence Preview
Deep insights for Refacto
Revenue Insights
- • Q4-2023: $52M (combined: ReFacto AF + Xyntha)
- • 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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.