Prescription medicine
Ferric derisomaltose Brand names: Monoferric
Ferric derisomaltose (Monoferric) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ferric derisomaltose FDA label on DailyMed (effective November 25, 2025, Pharmacosmos Therapeutics Inc.); the NDA 208171 record on Drugs@FDA; every ferric derisomaltose label on DailyMed.
Highlights of the record
FDA label of November 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMonoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron who have non-hemodialysis dependent chronic kidney disease (NDD-CKD) MONOFERRIC is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory
Forms and strengths
- 100 mg/ml
- 500 mg/5ml
- 1000 mg/10ml
Injection (solution).
On the market
- Earliest approval on file
- January 16, 2020 Monoferric, Pharmacosmos; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 22, 2036 Monoferric injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,305 through July 30, 2026
What is ferric derisomaltose used for?
From the label: indications and usageMonoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron who have non-hemodialysis dependent chronic kidney disease (NDD-CKD) MONOFERRIC is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron. ( 1 ) who have non-hemodialysis dependent chronic kidney disease.
Conditions named in the indications of ferric derisomaltose's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Monoferric), Pharmacosmos Therapeutics Inc., effective November 25, 2025 (SPL set 55859d2d-0456-4fa9-b41f-f535accc97db), via openFDA; the full label on DailyMed
Is there a generic for ferric derisomaltose (Monoferric)?
No generic ferric derisomaltose is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Monoferric injection: the compound patent runs to August 14, 2029, and the last listed entry to June 22, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for ferric derisomaltose?
The FDA Adverse Event Reporting System holds 1,305 reports that list ferric derisomaltose among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 46 are coded as a death and 219 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ferric derisomaltose?
8 other medicines are given the same way (intravenous) and in the same FDA class as ferric derisomaltose or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Epoetin | Anemia | none listed | $32.27 per mL 2,000 units/mL vial | No current entry |
| Darbepoetin alfa | Anemia | none listed | $446.58 per mL 25 mcg/0.42 mL syring | No current entry |
| Iron sucrose | Anemia | 3 labelers | n/a | A presentation being discontinued |
| Methoxy polyethylene glycol-epoetin beta | Anemia | none listed | n/a | No current entry |
| Ferumoxytol | Anemia | 1 labeler | n/a | No current entry |
| Sodium ferric gluconate complex | Anemia | 1 labeler | n/a | No current entry |
| Imetelstat | Anemia | none listed | n/a | No current entry |
| Nipocalimab | Anemia | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Ferric derisomaltose side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other