Data updated: Nov 8, 2026
Benefix (coagulation factor ix (recombinant)) · Pfizer
Approved 1997-02-11
1
Indication
--
Phase 3 Trials
29
Years on Market
Details
- Status
- Prescription
- First Approved
- 1997-02-11
- Patent Cliff
- 2004
- Revenue
- $102M (Q3-2026)
- Routes
- Intravenous
- Dosage Forms
- For Injection
Companies
Active Ingredient: Coagulation Factor IX (Recombinant) , Coagulation Factor IX (Recombinant) , Coagulation Factor IX (Recombinant) , Coagulation Factor IX (Recombinant) , Coagulation Factor IX (Recombinant)
Website: ↗
Benefix Approval History
1998
1999
2000
2001
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 1997 to 1997
Feb 1997 ORIGINAL
Update · CBER biologic (Purple Book)
What Benefix Treats
1 FDA approvalsOriginally approved for its first indication in 1997 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 1997)
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VIZIMPRO
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TALZENNA
2018 TALAZOPARIB TOSYLATE
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Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01174446 results posted | 250901 2009-016720-31 | Ph 3 | completed | Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients |
| NCT03186677 results posted | ISU304-001/CB2679d | Ph 1 | completed | Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients |
| NCT02336178 results posted | B1821052 2016-000765-22 | Ph 4 | completed | Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China |
| NCT02213250 results posted | B1821048 2015-003027-61 | Ph 1 | completed | An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B |
| NCT00866606 results posted | 3090A1-3305 B1821004 | Ph 3 | completed | Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects |
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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.
Benefix FDA Label Details
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Deep insights for Benefix
Revenue Insights
- • Q3-2026: $102M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2004
- • 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.