Hemin
As of the edition of 20 October 2026, Hemin is a small molecule: marketed, first approved in 1983 (US); US protection ended in 1995.
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
- Panhematin
- First approved
- 20 July 1983 (US)
- Approvals on record
- 6 in 6 regions
- Holder of the most recent approval
- RECORDATI RARE DISEASES COMÉRCIO DE MEDICAMENTOS LTDA - ME; 3 holders in all
- Registered trials
- 5, 2 stopped early
- Disease areas
- Digestive system; Inherited and neonatal; Nutrition and metabolism; Skin and connective tissue; Blood and lymph
US protection
US protection ended in 1995.
US protection ended in 1995, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Recordati Rare Diseases. The date is computed, not published.
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 | 0 | 1 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 3 | 1 | 0 | 2 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Recordati Rare Diseases | Applicant | 2018 to now |