Ferric carboxymaltose
As of the edition of 20 October 2026, Ferric carboxymaltose is a drug: marketed, first approved in 2013 (US); US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Unknown
- Brand name
- Injectafer
- First approved
- 25 July 2013 (US)
- Approvals on record
- 6 in 2 regions
- Holder of the most recent approval
- American Regent; 2 holders in all
- Registered trials
- 133, 14 stopped early
- Disease areas
- Blood and lymph; Nutrition and metabolism; Heart and blood vessels; Cancer; Digestive system; Urinary and reproductive
US protection
US protection ends in 2027.
The last listed US drug-substance patent ends in 2027. The application that gives this date is held by American Regent.
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 product8 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 8 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 22 | 13 | 2 | 0 |
| Phase 1 | 6 | 4 | 1 | 1 |
| Phase 2 | 16 | 8 | 1 | 4 |
| Phase 3 | 42 | 33 | 4 | 3 |
| Phase 4 | 47 | 16 | 10 | 6 |
| All trials | 133 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| American Regent | Acquired holder and Lead sponsor of trials | 2005 to now |
| Zeria Pharmaceutical | Applicant | 2019 to now |