Ferric maltol
As of the edition of 20 October 2026, Ferric maltol is a small molecule: marketed, first approved in 2016 (EU); US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Accrufer
- First approved
- 18 February 2016 (EU)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Shield Tx; 2 holders in all
- Registered trials
- 12, 2 stopped early
- Disease areas
- Blood and lymph; Nutrition and metabolism; Digestive system; Heart and blood vessels; Cancer; Lungs and airways
US protection
US protection ends in 2035.
The last listed US drug-substance patent ends in 2035. The application that gives this date is held by Shield Tx.
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 product2 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 3 | 7 | 6 | 0 | 1 |
| Phase 4 | 3 | 1 | 0 | 1 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Shield Tx | Applicant | 2019 to now |