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PEGylated Recombinant Factor VIII — Competitive Intelligence Brief
phase 3
Factor VIII replacement therapy
Factor VIII
Hemophilia A
Biologic
Live · refreshed every 30 min
Target snapshot
PEGylated Recombinant Factor VIII (PEGylated Recombinant Factor VIII) — Baxalta now part of Shire. PEGylated Recombinant Factor VIII is a recombinant form of human factor VIII that is modified with polyethylene glycol (PEG) to prolong its half-life.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| PEGylated Recombinant Factor VIII TARGET | PEGylated Recombinant Factor VIII | Baxalta now part of Shire | phase 3 | Factor VIII replacement therapy | Factor VIII | |
| Xyntha | xyntha | Pfizer | marketed | Recombinant protein therapy | Coagulation factor VIII | |
| Kogenate (BAY 14-2222) | Kogenate (BAY 14-2222) | Bayer | marketed | Recombinant coagulation factor VIII | Coagulation factor VIII | |
| von Willebrand factor | von Willebrand factor | National Center for Research Resources (NCRR) | marketed | Coagulation factor replacement | Von Willebrand factor receptor (GPIb-IX-V complex on platelets); Factor VIII binding site | |
| Alphanate SD/HT | Alphanate SD/HT | Grifols Biologicals, LLC | marketed | Clotting factor concentrate; Factor VIII replacement therapy | Factor VIII (antihemophilic factor) | |
| OBIZUR | OBIZUR | Baxalta now part of Shire | marketed | Recombinant coagulation factor VIII | Coagulation factor VIII | |
| Coagulation Factor VIII | Coagulation Factor VIII | Beijing Children's Hospital | marketed | Coagulation factor replacement | Coagulation Factor VIII (antihemophilic factor) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Factor VIII replacement therapy class)
- Baxalta now part of Shire · 2 drugs in this class
- Bayer · 1 drug in this class
- CSL Behring · 1 drug in this class
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Cite this brief
Drug Landscape (2026). PEGylated Recombinant Factor VIII — Competitive Intelligence Brief. https://druglandscape.com/ci/pegylated-recombinant-factor-viii. Accessed 2026-05-16.
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