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BAX 326 — Competitive Intelligence Brief
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)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / 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)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Recombinant coagulation factor VIII class)
- Baxalta now part of Shire · 2 drugs in this class
- Bayer · 2 drugs in this class
- Pfizer · 2 drugs in this class
- The League of Clinical Research, Russia · 1 drug in this class
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- Whole Recombinant coagulation factor VIII class — RSS
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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