Meropenem
As of the edition of 20 October 2026, Meropenem is a small molecule: marketed, first approved in 1995 (CH); 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 2024
- Kind
- Small molecule
- Brand name
- Merrem IV
- First approved
- 28 December 1995 (CH)
- Approvals on record
- 15 in 7 regions
- Holder of the most recent approval
- B. Braun Medical; 7 holders in all
- Registered trials
- 93, 10 stopped early
- Disease areas
- Infections; Lungs and airways; Digestive system; Pregnancy and women's health; Urinary and reproductive; Inherited and neonatal
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.
Rempex Pharmaceuticals Inc A Wholly Owned Sub Of Melinta Therapeutics holds a later exclusivity on its own new formulation or combination product, ending 2031; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 26 | 10 | 2 | 4 |
| Phase 1 | 12 | 11 | 0 | 0 |
| Phase 2 | 15 | 8 | 4 | 1 |
| Phase 3 | 18 | 6 | 5 | 5 |
| Phase 4 | 22 | 15 | 2 | 0 |
| All trials | 93 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant and Lead sponsor of trials | 1995 to now |
| AstraZeneca | Applicant | 1996 to now |
| B. Braun Medical | Later holder | 2015 to now |
| Menarini | Applicant | 2018 to now |
| Hq Specialty Pharma | Later holder | 2023 to now |
| Dainippon Sumitomo Pharma | Applicant |