Imipenem anhydrous
As of the edition of 20 October 2026, Imipenem anhydrous is a small molecule: marketed, first approved in 1985 (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 2026
- Kind
- Small molecule
- Brand name
- Primaxin
- First approved
- 26 November 1985 (US)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- Merck & Co.; 2 holders in all
- Registered trials
- 40, 4 stopped early
- Disease areas
- Infections; Lungs and airways; Blood and lymph; Cancer; Digestive system; Heart and blood vessels
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 | 7 | 4 | 0 | 0 |
| Phase 1 | 6 | 5 | 1 | 0 |
| Phase 2 | 6 | 4 | 2 | 0 |
| Phase 3 | 10 | 6 | 3 | 0 |
| Phase 4 | 11 | 5 | 0 | 4 |
| All trials | 40 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Labatec Pharma | Applicant | 2009 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2011 to now |