Human immunoglobulin g
As of the edition of 20 October 2026, Human immunoglobulin g is a drug: marketed, first approved in 1944 (US); US protection ended in 2015.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Unknown
- Brand name
- Baygam
- First approved
- 11 January 1944 (US)
- Approvals on record
- 71 in 3 regions
- Holder of the most recent approval
- Grifols Therapeutics; 9 holders in all
- Registered trials
- 188, 27 stopped early
- Disease areas
- Immune system; Nervous system; Inherited and neonatal; Blood and lymph; Infections; Cancer
US protection
US protection ended in 2015.
The orphan exclusivity ended in 2015 (it covers one use only).
Takeda holds a later exclusivity on its own new formulation or combination product, ending 2031; it does not protect the original drug.
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 product3 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 | 16 | 10 | 2 | 0 |
| Phase 1 | 12 | 9 | 0 | 3 |
| Phase 2 | 49 | 30 | 7 | 8 |
| Phase 3 | 87 | 55 | 14 | 13 |
| Phase 4 | 24 | 12 | 3 | 3 |
| All trials | 188 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Grifols Therapeutics | Applicant and Lead sponsor of trials | 1944 to now |
| CSL Behring | Later holder and Lead sponsor of trials | 2004 to now |
| Takeda | Applicant, Later holder and Lead sponsor of trials | 2006 to now |
| Instituto Grifols | Later holder and Lead sponsor of trials | 2007 to now |
| Octapharma Pharmazeutika Produktionsges.m.b.H | Applicant | 2018 to now |