Lovastatin
As of the edition of 20 October 2026, Lovastatin is a small molecule: marketed, first approved in 1987 (US); acts on HMGCR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1990
- Kind
- Small molecule
- Brand name
- Mevacor
- First approved
- 31 August 1987 (US)
- Approvals on record
- 12 in 2 regions
- Holder of the most recent approval
- AbbVie; 4 holders in all
- Registered trials
- 49, 10 stopped early
- Disease areas
- Cancer; Nervous system; Heart and blood vessels; Inherited and neonatal; Nutrition and metabolism; Skin and connective tissue
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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Lovastatin.
See the 1 company 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 | 6 | 5 | 0 | 1 |
| Phase 1 | 8 | 7 | 0 | 1 |
| Phase 2 | 24 | 11 | 2 | 8 |
| Phase 3 | 8 | 8 | 0 | 0 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 49 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 1985 to now |
| Actavis | Later holder | 2002 to now |
| Azurity Pharmaceuticals | Acquired holder | 2026 to now |