rIX-FP — Competitive Intelligence Brief

rIX-FP (rIX-FP) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Factor VIII replacement therapy. Area: Hematology.

phase 3 Factor VIII replacement therapy Factor VIII Hematology Biologic

Target snapshot

rIX-FP (rIX-FP) — CSL Behring. rIX-FP is a recombinant, humanized monoclonal antibody that targets factor VIII to prevent bleeding in patients with hemophilia A.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
rIX-FP TARGET	rIX-FP	CSL Behring	phase 3	Factor VIII replacement therapy	Factor VIII
Xyntha	xyntha	Pfizer	marketed	Recombinant protein therapy	Coagulation factor VIII
Recombinant Human Coagulation FVIII	Recombinant Human Coagulation FVIII	Sinocelltech Ltd.	marketed	Coagulation factor replacement therapy	Coagulation Factor VIII
Intravenous infusions of Xyntha	Intravenous infusions of Xyntha	Pfizer	marketed	Recombinant coagulation factor VIII	Coagulation factor VIII
rFVIIIFc	rFVIIIFc	Bioverativ Therapeutics Inc.	marketed	Recombinant clotting factor (Factor VIII replacement therapy)	Factor VIII / FcRn (neonatal Fc receptor)
Kogenate (BAY 14-2222)	Kogenate (BAY 14-2222)	Bayer	marketed	Recombinant coagulation factor VIII	Coagulation factor VIII
Recombinant Von Willebrand factor	Recombinant Von Willebrand factor	Nicoletta C Machin	marketed	Recombinant coagulation factor	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 (Factor VIII replacement therapy class)

1. Baxalta now part of Shire · 2 drugs in this class
2. Bayer · 1 drug in this class
3. CSL Behring · 1 drug in this class