Factor Concentrate (Bebulin) — Competitive Intelligence Brief

Factor Concentrate (Bebulin) (Factor Concentrate (Bebulin)) competitive landscape: 4 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Prothrombin complex concentrate (PCC). Area: Hematology.

marketed Prothrombin complex concentrate (PCC) Coagulation factors II, VII, IX, X Hematology Biologic

Target snapshot

Factor Concentrate (Bebulin) (Factor Concentrate (Bebulin)) — The University of Texas Health Science Center, Houston. Bebulin is a prothrombin complex concentrate that replaces deficient vitamin K-dependent clotting factors (II, VII, IX, X) to restore hemostatic function.

Comparator set (4 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Factor Concentrate (Bebulin) TARGET	Factor Concentrate (Bebulin)	The University of Texas Health Science Center, Houston	marketed	Prothrombin complex concentrate (PCC)	Coagulation factors II, VII, IX, X
Prothrombin complex	Prothrombin complex	IRCCS Policlinico S. Donato	marketed	Vitamin K-dependent clotting factor concentrate	Coagulation factors II, VII, IX, X
Pro-Thrombin Concentrate Complex	Pro-Thrombin Concentrate Complex	University Hospital, Grenoble	phase 3	Clotting factor concentrate	Coagulation factors II, VII, IX, X
Haemocomplettan® P	Haemocomplettan® P	CSL Behring	marketed	Prothrombin complex concentrate (PCC)	Clotting factors II, VII, IX, X
Beriplex® P/N (Kcentra)	Beriplex® P/N (Kcentra)	CSL Behring	phase 3	Prothrombin complex concentrate (PCC)	Vitamin K-dependent clotting factors (Factors II, VII, IX, X)

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 (Prothrombin complex concentrate (PCC) class)

1. CSL Behring · 2 drugs in this class
2. The University of Texas Health Science Center, Houston · 1 drug in this class