Albumin human
As of the edition of 20 October 2026, Albumin human is a protein: marketed, first approved in 1942 (US); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1997
- Kind
- Protein
- Brand name
- Albuked
- First approved
- 21 October 1942 (US)
- Approvals on record
- 74 in 4 regions
- Holder of the most recent approval
- LEADER PHARMA DISTRIBUIDORA E IMPORTADORA DE PRODUTOS FARMACEUT; 23 holders in all
- Registered trials
- 128, 22 stopped early
- Disease areas
- Digestive system; Nervous system; Pregnancy and women's health; Urinary and reproductive; Infections; Heart and blood vessels
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
GE Healthcare holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 51 | 28 | 9 | 3 |
| Phase 1 | 7 | 4 | 0 | 3 |
| Phase 2 | 24 | 11 | 5 | 6 |
| Phase 3 | 22 | 10 | 4 | 6 |
| Phase 4 | 24 | 9 | 4 | 4 |
| All trials | 128 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Grifols Therapeutics | Applicant and Lead sponsor of trials | 1942 to now |
| Takeda | Acquired holder, Later holder and Lead sponsor of trials | 1954 to now |
| CSL Behring | Later holder | 1976 to now |
| Grifols Biologicals | Later holder | 1978 to now |
| Central Laboratory of the Netherlands Red Cross Blood Transfusion Service | Later holder | 1979 to now |
| Instituto Grifols | Later holder and Lead sponsor of trials | 1995 to now |
| Byk-Mallinckrodt CIL | Later holder | 1997 to now |
| Blau Farmaceutica | Applicant | 2000 to now |
| GE Healthcare | Acquired holder | 2005 to now |
| Alk-Abello | Applicant | 2006 to now |
| Octapharma Pharmazeutika Produktionsges.m.b.H | Later holder | 2006 to now |
| Kedrion | Later holder and Lead sponsor of trials | 2011 to now |
| Greer | Later holder | 2014 to now |
| Kedrion Biopharma | Acquired holder | 2025 to now |