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Coagadex(R) — Competitive Intelligence Brief

Coagadex(R) (Coagadex(R)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Recombinant clotting factor. Area: Hematology.

phase 3 Recombinant clotting factor Factor X (coagulation factor X) Hematology Biologic Live · refreshed every 30 min

Target snapshot

Coagadex(R) (Coagadex(R)) — Kedrion S.p.A.. Coagadex is a recombinant human vitamin K-dependent clotting factor X that replaces deficient or dysfunctional Factor X to restore blood coagulation.

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
Coagadex(R) TARGET Coagadex(R) Kedrion S.p.A. phase 3 Recombinant clotting factor Factor X (coagulation factor X)
Afstyla® Afstyla® CSL Behring marketed Recombinant clotting factor VIII 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
Recombinant factor IX Recombinant factor IX Baxalta now part of Shire marketed Recombinant clotting factor Coagulation factor IX (F9)
ReFacto ReFacto Wyeth is now a wholly owned subsidiary of Pfizer marketed Recombinant clotting factor Factor VIII (antihemophilic factor)
rFVIIIFc rFVIIIFc Bioverativ Therapeutics Inc. marketed Recombinant clotting factor (Factor VIII replacement therapy) Factor VIII / FcRn (neonatal Fc receptor)
Factor VIII (rFVIIIFc) Factor VIII (rFVIIIFc) Bioverativ Therapeutics Inc. phase 3 Recombinant clotting factor Factor VIII / Intrinsic tenase complex

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 clotting factor class)

  1. Baxalta now part of Shire · 2 drugs in this class
  2. Bioverativ Therapeutics Inc. · 1 drug in this class
  3. Kedrion S.p.A. · 1 drug in this class
  4. Octapharma · 1 drug in this class
  5. Wyeth is now a wholly owned subsidiary of Pfizer · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Coagadex(R) — Competitive Intelligence Brief. https://druglandscape.com/ci/coagadex-r. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing