Ferric Carboxymaltose (FCM) — Competitive Intelligence Brief

Ferric Carboxymaltose (FCM) (Ferric Carboxymaltose (FCM)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Intravenous iron replacement agent. Area: Hematology.

marketed Intravenous iron replacement agent Iron (Fe³⁺) delivery; transferrin and ferritin binding Hematology Small molecule

Target snapshot

Ferric Carboxymaltose (FCM) (Ferric Carboxymaltose (FCM)) — American Regent, Inc.. Ferric carboxymaltose delivers iron directly into the bloodstream as a stable iron-carbohydrate complex that is taken up by iron-binding proteins to replenish depleted iron stores.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Ferric Carboxymaltose (FCM) TARGET	Ferric Carboxymaltose (FCM)	American Regent, Inc.	marketed	Intravenous iron replacement agent	Iron (Fe³⁺) delivery; transferrin and ferritin binding
intravenous iron carboxymaltose	intravenous iron carboxymaltose	University of Zurich	marketed	Intravenous iron replacement agent	Iron (Fe³⁺) delivery system; transferrin receptor-mediated uptake
SFP	SFP	Rockwell Medical Technologies, Inc.	marketed	Intravenous iron replacement agent	Iron (Fe3+) for hemoglobin synthesis and erythropoiesis
Iron Carboxymaltose	Iron Carboxymaltose	Albina Nowak, MD	marketed	Intravenous iron replacement agent	Iron(III) ion; transferrin and ferritin (iron-binding proteins)
Iron Sucrose (Venofer)	Iron Sucrose (Venofer)	American Regent, Inc.	marketed	Intravenous iron replacement agent
IK-3001	IK-3001	Mallinckrodt	phase 3	Intravenous iron replacement agent	Iron (Fe3+) delivery system
FCM	FCM	AMAG Pharmaceuticals, Inc.	phase 3	Intravenous iron replacement agent	Iron (Fe3+) delivery via transferrin-mediated uptake

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 (Intravenous iron replacement agent class)

1. American Regent, Inc. · 2 drugs in this class
2. AMAG Pharmaceuticals, Inc. · 1 drug in this class
3. Albina Nowak, MD · 1 drug in this class
4. Mallinckrodt · 1 drug in this class
5. Rockwell Medical Technologies, Inc. · 1 drug in this class
6. University of Zurich · 1 drug in this class