Hepatitis b virus hbsag surface protein antigen
As of the edition of 20 October 2026, Hepatitis b virus hbsag surface protein antigen is a vaccine component: marketed, first approved in 1986 (US); US protection ended in 1998.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Vaccine component
- Brand name
- Recombivax
- First approved
- 23 July 1986 (US)
- Approvals on record
- 21 in 3 regions
- Holder of the most recent approval
- Merck & Co.; 6 holders in all
- Registered trials
- 119, 6 stopped early
- Disease areas
- Infections; Digestive system; Urinary and reproductive; Immune system; Pregnancy and women's health; Cancer
US protection
US protection ended in 1998.
US protection ended in 1998, computed as 12 years from the first US licence because FDA publishes no date for this product. The date is computed, not published.
VBI Vaccines holds a later exclusivity on its own new formulation or combination product, ending 2033; 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 24 | 18 | 1 | 1 |
| Phase 1 | 12 | 10 | 1 | 0 |
| Phase 2 | 17 | 13 | 1 | 1 |
| Phase 3 | 26 | 22 | 1 | 2 |
| Phase 4 | 40 | 31 | 3 | 2 |
| All trials | 119 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 1986 to now |
| GSK | Applicant, Later holder and Lead sponsor of trials | 1989 to now |
| Dynavax | Applicant | 2021 to now |
| VBI Vaccines | Later holder | 2021 to now |