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BAX 326 — Competitive Intelligence Brief

BAX 326 (BAX 326) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Recombinant coagulation factor VIII. Area: Hematology.

phase 3 Recombinant coagulation factor VIII Coagulation factor VIII Hematology Biologic Live · refreshed every 30 min

Target snapshot

BAX 326 (BAX 326) — Baxalta now part of Shire. BAX 326 is a recombinant human coagulation factor VIII designed to treat hemophilia A by replacing deficient or dysfunctional factor VIII.

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
BAX 326 TARGET BAX 326 Baxalta now part of Shire phase 3 Recombinant coagulation factor VIII Coagulation factor VIII
Moroctocog alfa (AF-CC) Moroctocog alfa (AF-CC) Pfizer marketed Recombinant coagulation factor VIII Coagulation factor VIII
Intravenous infusions of Xyntha Intravenous infusions of Xyntha Pfizer marketed Recombinant coagulation factor VIII Coagulation factor VIII
Kogenate (BAY14-2222) Kogenate (BAY14-2222) Bayer marketed Recombinant coagulation factor VIII 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
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 coagulation factor VIII class)

  1. Baxalta now part of Shire · 2 drugs in this class
  2. Bayer · 2 drugs in this class
  3. Pfizer · 2 drugs in this class
  4. The League of Clinical Research, Russia · 1 drug in this class

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Cite this brief

Drug Landscape (2026). BAX 326 — Competitive Intelligence Brief. https://druglandscape.com/ci/bax-326. Accessed 2026-05-14.

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