Doripenem
As of the edition of 20 October 2026, Doripenem is a small molecule: marketed, first approved in 2007 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2007
- Kind
- Small molecule
- Brand name
- Doribax
- First approved
- 12 October 2007 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Shionogi
- Withdrawn from market
- 31 July 2014 (in some regions)
- Registered trials
- 22, 6 stopped early
- Disease areas
- Infections; Lungs and airways; Pregnancy and women's health; Urinary and reproductive; Digestive system; Injuries
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 2 | 2 | 0 | 0 |
| Phase 3 | 11 | 6 | 0 | 5 |
| Phase 4 | 5 | 5 | 0 | 0 |
| All trials | 22 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Earlier holder and Lead sponsor of trials | 2003 to now |
| Shionogi | Acquired holder | 2014 to now |