Methenamine
As of the edition of 20 October 2026, Methenamine is a small molecule: marketed, first approved in 1968 (CH).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1982
- Kind
- Small molecule
- Brand name
- Hiprex
- First approved
- 1 May 1968 (CH)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Quagen Pharmaceuticals; 3 holders in all
- Registered trials
- 10, 3 stopped early
- Disease areas
- Pregnancy and women's health; Urinary and reproductive; Infections
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 | 1 | 1 | 0 | 0 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 3 | 2 | 1 | 0 | 1 |
| Phase 4 | 5 | 2 | 1 | 2 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Esjay Pharma | Acquired holder | 2024 to now |
| Quagen Pharmaceuticals | Acquired holder | 2025 to now |
| 3M | Earlier holder | |
| Sanofi | Later holder |