iron isomaltoside(Monofer®) — Competitive Intelligence Brief

iron isomaltoside(Monofer®) (iron isomaltoside(Monofer®)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Iron replacement agent. Area: Hematology.

phase 3 Iron replacement agent Iron transporter (DMT1/SLC11A2) Hematology Small molecule

Target snapshot

iron isomaltoside(Monofer®) (iron isomaltoside(Monofer®)) — Prince of Wales Hospital, Shatin, Hong Kong. Iron isomaltoside is an iron carbohydrate complex that delivers iron to iron-deficient patients by binding iron in a stable complex that is taken up by iron-transporting cells.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
iron isomaltoside(Monofer®) TARGET	iron isomaltoside(Monofer®)	Prince of Wales Hospital, Shatin, Hong Kong	phase 3	Iron replacement agent	Iron transporter (DMT1/SLC11A2)
Triferic AVNU	Triferic AVNU	Rockwell Medical Technologies, Inc.	marketed	Iron replacement agent	Iron (Fe3+) delivery system
Aggressive iron dextran supplementation	Aggressive iron dextran supplementation	Shanghai East Hospital	marketed	Iron replacement agent	Iron (Fe3+) for hemoglobin and myoglobin synthesis
intravenous iron carboxymaltose	intravenous iron carboxymaltose	University of Zurich	marketed	Intravenous iron replacement agent	Iron (Fe³⁺) delivery system; transferrin receptor-mediated uptake
Intravenous iron sucrose	Intravenous iron sucrose	Ain Shams University	marketed	Iron replacement agent
Generic sodium ferric gluconate	Generic sodium ferric gluconate	University of Maryland, Baltimore	marketed	Iron replacement agent	Iron (Fe3+) delivery; hemoglobin and myoglobin synthesis
High-dose ferric derisomaltose	High-dose ferric derisomaltose	China-Japan Friendship Hospital	marketed	Iron replacement agent

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 (Iron replacement agent class)

1. University of Maryland, Baltimore · 2 drugs in this class
2. Ain Shams University · 1 drug in this class
3. American Regent, Inc. · 1 drug in this class
4. Azad Pharma AG · 1 drug in this class
5. CN NGANOU-GNINDJIO, MD, MSc · 1 drug in this class
6. China-Japan Friendship Hospital · 1 drug in this class
7. Hallym University Medical Center · 1 drug in this class
8. J. Uriach and Company · 1 drug in this class
9. JW Pharmaceutical · 1 drug in this class
10. Prince of Wales Hospital, Shatin, Hong Kong · 1 drug in this class