Ribavirin
As of the edition of 20 October 2026, Ribavirin is a small molecule: marketed, first approved in 1985 (US); acts on IMPDH1; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2001
- Kind
- Small molecule
- Brand name
- Virazole
- First approved
- 31 December 1985 (US)
- Approvals on record
- 20 in 3 regions
- Holder of the most recent approval
- Merck & Co.; 4 holders in all
- Withdrawn from market
- 18 October 2023 (in some regions)
- Registered trials
- 679, 91 stopped early
- Disease areas
- Infections; Digestive system; Immune system; Urinary and reproductive; Cancer; Blood and lymph
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Roche holds a later exclusivity on its own new formulation or combination product, which ended in 2016; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Ribavirin.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| IMPDH1 | Inosine-5'-monophosphate dehydrogenase 1 | P20839 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 95 | 64 | 0 | 16 |
| Phase 1 | 31 | 26 | 0 | 5 |
| Phase 2 | 230 | 197 | 2 | 25 |
| Phase 3 | 213 | 174 | 1 | 28 |
| Phase 4 | 110 | 84 | 0 | 17 |
| All trials | 679 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Applicant and Lead sponsor of trials | 1985 to now |
| Roche | Applicant, Later holder and Lead sponsor of trials | 2001 to now |
| Merck & Co. | Acquired holder and Lead sponsor of trials | 2002 to now |