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rFVIII (BAY81-8973) on demand — Competitive Intelligence Brief

rFVIII (BAY81-8973) on demand (rFVIII (BAY81-8973) on demand) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: recombinant factor VIII replacement therapy. Area: Hematology.

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)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / 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)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (recombinant factor VIII replacement therapy class)

  1. 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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