Ferric oxyhydroxide
As of the edition of 20 October 2026, Ferric oxyhydroxide is a small molecule: marketed, first approved in 2013 (US); US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Velphoro
- First approved
- 27 November 2013 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Kissei Pharmaceutical; 2 holders in all
- Registered trials
- 41, 8 stopped early
- Disease areas
- Blood and lymph; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive; Cancer; Heart and blood vessels
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Vifor Fresenius Medical Care Renal Pharma.
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.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 0 | 2 |
| Phase 1 | 5 | 4 | 0 | 1 |
| Phase 2 | 7 | 3 | 2 | 2 |
| Phase 3 | 12 | 11 | 0 | 1 |
| Phase 4 | 14 | 11 | 1 | 2 |
| All trials | 41 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Vifor Fresenius Medical Care Renal Pharma | Originator and Lead sponsor of trials | 2013 to now |
| Kissei Pharmaceutical | Applicant and Lead sponsor of trials | 2015 to now |