Ferric derisomaltose
As of the edition of 20 October 2026, Ferric derisomaltose is an oligosaccharide: marketed, first approved in 2020 (US); acts on TF; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Oligosaccharide
- Brand name
- Monoferric
- First approved
- 16 January 2020 (US)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Nippon Shinyaku; 2 holders in all
- Registered trials
- 27, 0 stopped early
- Disease areas
- Nutrition and metabolism; Blood and lymph; Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive; Mental health
US protection
US protection ends in 2029.
The last listed US drug-substance patent ends in 2029. The application that gives this date is held by Pharmacosmos.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product12 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Ferric derisomaltose.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| TF | Serotransferrin | P02787 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 1 | 1 | 0 |
| Phase 1 | 2 | 0 | 2 | 0 |
| Phase 2 | 2 | 0 | 2 | 0 |
| Phase 3 | 7 | 0 | 5 | 0 |
| Phase 4 | 12 | 4 | 6 | 0 |
| All trials | 27 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pharmacosmos | Originator and Lead sponsor of trials | 2020 to now |
| Nippon Shinyaku | Applicant | 2022 to now |