Simvastatin
As of the edition of 20 October 2026, Simvastatin is a small molecule: marketed, first approved in 1988 (FR); acts on HMGCR; 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 2013
- Kind
- Small molecule
- Brand name
- Zocor
- First approved
- 6 May 1988 (FR)
- Approvals on record
- 31 in 6 regions
- Holder of the most recent approval
- Salerno Pharmaceuticals; 10 holders in all
- Registered trials
- 403, 43 stopped early
- Disease areas
- Nutrition and metabolism; Heart and blood vessels; Cancer; Hormones; Nervous system; Digestive system
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.
Merck & Co. holds a later exclusivity on its own new formulation or combination product, which ended in 2026; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Simvastatin.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HMGCR | 3-hydroxy-3-methylglutaryl-coenzyme A reductase | P04035 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 55 | 33 | 5 | 8 |
| Phase 1 | 90 | 67 | 8 | 6 |
| Phase 2 | 79 | 43 | 13 | 12 |
| Phase 3 | 99 | 80 | 5 | 10 |
| Phase 4 | 80 | 54 | 4 | 7 |
| All trials | 403 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 1991 to now |
| Organon | Applicant, Acquired holder and Lead sponsor of trials | 2000 to now |
| Synthon Pharmaceuticals | Later holder | 2007 to now |
| Viatris | Acquired holder | 2013 to now |
| Rosemont Pharmaceuticals | Later holder | 2016 to now |
| Salerno Pharmaceuticals | Acquired holder | 2024 to now |