ADYNOVI — Competitive Intelligence Brief

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

phase 2 Factor VIII replacement therapy Factor VIII Hematology Biologic

Target snapshot

ADYNOVI (ADYNOVI) — Baxalta now part of Shire. ADYNOVI is a recombinant human coagulation factor VIII, used to treat and prevent bleeding episodes in patients with hemophilia A.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
ADYNOVI TARGET	ADYNOVI	Baxalta now part of Shire	phase 2	Factor VIII replacement therapy	Factor VIII
Alphanate SD/HT	Alphanate SD/HT	Grifols Biologicals, LLC	marketed	Clotting factor concentrate; Factor VIII replacement therapy	Factor VIII (antihemophilic factor)
Intravenous infusions of Xyntha	Intravenous infusions of Xyntha	Pfizer	marketed	Recombinant coagulation factor VIII	Coagulation factor VIII
Moroctocog alfa (AF-CC)	Moroctocog alfa (AF-CC)	Pfizer	marketed	Recombinant coagulation factor VIII	Coagulation factor VIII
Plasma-derived FVIII/VWF concentrate	Plasma-derived FVIII/VWF concentrate	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	marketed	Coagulation factor concentrate	Factor VIII and von Willebrand Factor
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 (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