Hepatitis b immune globulin
As of the edition of 20 October 2026, Hepatitis b immune globulin is a drug: marketed, first approved in 1977 (US); US protection ended in 1989.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Unknown
- Brand name
- Bayhep B
- First approved
- 23 September 1977 (US)
- Approvals on record
- 16 in 3 regions
- Holder of the most recent approval
- Grifols Therapeutics; 5 holders in all
- Withdrawn from market
- 6 September 2010 (in some regions)
- Registered trials
- 18, 6 stopped early
- Disease areas
- Digestive system; Infections; Cancer
US protection
US protection ended in 1989.
US protection ended in 1989, computed as 12 years from the first US licence because FDA publishes no date for this product. The date is computed, not published.
Kamada holds a later exclusivity on its own new formulation or combination product, which ended in 2014; 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 product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 2 | 1 | 1 | 0 |
| Phase 2 | 7 | 2 | 0 | 5 |
| Phase 3 | 5 | 4 | 0 | 1 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 18 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Biotest | Applicant and Lead sponsor of trials | 1999 to now |
| Grifols Therapeutics | Applicant | 2021 to now |