Sulfadiazine
As of the edition of 20 October 2026, Sulfadiazine is a small molecule: marketed, first approved in 1945 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Silvadene
- First approved
- 1 August 1945 (ES)
- Approvals on record
- 18 in 5 regions
- Holder of the most recent approval
- IBSA Institut Biochimique; 12 holders in all
- Registered trials
- 9, 1 stopped early
- Disease areas
- Immune system; Infections; Injuries; Urinary and reproductive; Cancer; Nervous system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 1 | 0 |
| Phase 2 | 2 | 1 | 0 | 1 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 3 | 2 | 1 | 0 |
| All trials | 9 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alliance Pharmaceuticals | Applicant | 1974 to now |
| Basf | Later holder | 1982 to now |
| Chesebrough Ponds | Later holder | 1985 to now |
| IBSA Institut Biochimique | Later holder | 1992 to now |
| Franklin Pharmaceuticals | Acquired holder | 2003 to now |
| AbbVie | Acquired holder | 2012 to now |
| Thepharmanetwork | Acquired holder | 2012 to now |
| Pfizer | Applicant, Acquired holder and Later holder | 2017 to now |
| Cristália Produtos Químicos Farmacêuticos Ltda | Applicant | 2021 to now |
| Dr. Reddy's | Acquired holder | 2024 to now |
| Abbott | Later holder | |
| Eli Lilly | Later holder |