Ramipril
As of the edition of 20 October 2026, Ramipril is a small molecule: marketed, first approved in 1991 (US); acts on ACE; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2003
- Kind
- Small molecule
- Brand name
- Altace
- First approved
- 28 January 1991 (US)
- Approvals on record
- 26 in 5 regions
- Holder of the most recent approval
- Rosemont Pharmaceuticals; 6 holders in all
- Registered trials
- 100, 9 stopped early
- Disease areas
- Heart and blood vessels; Urinary and reproductive; Pregnancy and women's health; Nutrition and metabolism; Hormones; Immune system
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.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Ramipril.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ACE | Angiotensin-converting enzyme | P12821 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 7 | 2 | 1 |
| Phase 1 | 20 | 20 | 0 | 0 |
| Phase 2 | 9 | 7 | 0 | 2 |
| Phase 3 | 24 | 18 | 1 | 3 |
| Phase 4 | 37 | 27 | 3 | 3 |
| All trials | 100 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant, Earlier holder and Lead sponsor of trials | 1991 to now |
| Bausch Health | Acquired holder | 1996 to now |
| Pfizer | Acquired holder, Later holder and Lead sponsor of trials | 2002 to now |
| Rosemont Pharmaceuticals | Later holder | 2025 to now |