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FVIII Replacement — Competitive Intelligence Brief

FVIII Replacement (FVIII Replacement) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Coagulation factor replacement. Area: Rare Disease.

phase 2 Coagulation factor replacement Factor VIII Rare Disease Small molecule Live · refreshed every 30 min

Target snapshot

FVIII Replacement (FVIII Replacement) — Hoffmann-La Roche. Recombinant FVIII replacement to correct FVIII deficiency

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
FVIII Replacement TARGET FVIII Replacement Hoffmann-La Roche phase 2 Coagulation factor replacement Factor VIII
Moroctocog alfa (AF-CC) Moroctocog alfa (AF-CC) Pfizer marketed Recombinant coagulation factor VIII Coagulation factor VIII
Recombinant Human Coagulation FVIII Recombinant Human Coagulation FVIII Sinocelltech Ltd. marketed Coagulation factor replacement therapy Coagulation Factor VIII
OBIZUR OBIZUR Baxalta now part of Shire marketed Recombinant coagulation factor VIII Coagulation factor VIII
Recombinant Factor VIII (rAHF) Recombinant Factor VIII (rAHF) Baxalta now part of Shire marketed Recombinant clotting factor Coagulation Factor VIII
Coagulation Factor VIII Coagulation Factor VIII Beijing Children's Hospital marketed Coagulation factor replacement Coagulation Factor VIII (antihemophilic factor)
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

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 (Coagulation factor replacement class)

  1. Beijing Children's Hospital · 1 drug in this class
  2. Bioverativ Therapeutics Inc. · 1 drug in this class
  3. Hoffmann-La Roche · 1 drug in this class
  4. National Center for Research Resources (NCRR) · 1 drug in this class
  5. Takeda · 1 drug in this class
  6. Wyeth is now a wholly owned subsidiary of Pfizer · 1 drug in this class

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Cite this brief

Drug Landscape (2026). FVIII Replacement — Competitive Intelligence Brief. https://druglandscape.com/ci/fviii-replacement. Accessed 2026-05-13.

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