Rho (d) immune globulin
As of the edition of 20 October 2026, Rho (d) immune globulin is a drug: marketed, first approved in 1971 (US); US protection ended in 1983.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2007
- Kind
- Unknown
- Brand name
- Bayrho-D
- First approved
- 11 June 1971 (US)
- Approvals on record
- 28 in 2 regions
- Holder of the most recent approval
- Grifols Therapeutics; 5 holders in all
- Registered trials
- 1, 1 stopped early
- Disease areas
- Blood and lymph; Digestive system; Immune system; Infections; Urinary and reproductive
US protection
US protection ended in 1983.
US protection ended in 1983, 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 2002; 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 4 | 1 | 0 | 0 | 1 |
| All trials | 1 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Grifols Therapeutics | Applicant | 1971 to now |
| Kedrion Biopharma | Later holder | 1998 to now |