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rFVIII (BAY81-8973) on demand — Competitive Intelligence Brief
phase 3
recombinant factor VIII replacement therapy
Factor VIII
Hematology
Biologic
Live · refreshed every 30 min
Target snapshot
rFVIII (BAY81-8973) on demand (rFVIII (BAY81-8973) on demand) — Bayer. rFVIII (BAY81-8973) is a recombinant factor VIII replacement therapy that mimics the natural protein to treat bleeding episodes in patients with hemophilia A.
Comparator set (6 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| rFVIII (BAY81-8973) on demand TARGET | rFVIII (BAY81-8973) on demand | Bayer | phase 3 | recombinant factor VIII replacement therapy | Factor VIII | |
| rFVIIIFc | rFVIIIFc | Bioverativ Therapeutics Inc. | marketed | Recombinant clotting factor (Factor VIII replacement therapy) | Factor VIII / FcRn (neonatal Fc receptor) | |
| ReFacto | ReFacto | Wyeth is now a wholly owned subsidiary of Pfizer | marketed | Recombinant clotting factor | Factor VIII (antihemophilic factor) | |
| Plasma-derived FVIII/VWF concentrate | Plasma-derived FVIII/VWF concentrate | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | marketed | Coagulation factor concentrate | Factor VIII and von Willebrand Factor | |
| OBIZUR | OBIZUR | Baxalta now part of Shire | marketed | Recombinant coagulation factor VIII | Coagulation factor VIII | |
| Traditional Cryoprecipitate | Traditional Cryoprecipitate | Weill Medical College of Cornell University | marketed | Blood product; clotting factor concentrate | Fibrinogen, Factor VIII, von Willebrand factor, Fibronectin, Factor XIII | |
| Afstyla® | Afstyla® | CSL Behring | marketed | Recombinant clotting factor VIII | Factor VIII (coagulation factor VIII) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (recombinant factor VIII replacement therapy class)
- Bayer · 1 drug in this class
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Cite this brief
Drug Landscape (2026). rFVIII (BAY81-8973) on demand — Competitive Intelligence Brief. https://druglandscape.com/ci/rfviii-bay81-8973-on-demand. Accessed 2026-05-16.
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