Atorvastatin
As of the edition of 20 October 2026, Atorvastatin is a small molecule: marketed, first approved in 1996 (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 2021
- Kind
- Small molecule
- Brand name
- Lipitor
- First approved
- 17 December 1996 (US)
- Approvals on record
- 26 in 6 regions
- Holder of the most recent approval
- Cmp; 10 holders in all
- Registered trials
- 681, 69 stopped early
- Disease areas
- Nutrition and metabolism; Heart and blood vessels; Nervous system; Hormones; Urinary and reproductive; Cancer
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
4 companies on route B because of this drug.
Companies on route B for this drug
In the product4 companies are on route B because of Atorvastatin.
See the 4 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 | 99 | 56 | 12 | 11 |
| Phase 1 | 130 | 105 | 13 | 5 |
| Phase 2 | 128 | 79 | 17 | 15 |
| Phase 3 | 153 | 99 | 9 | 24 |
| Phase 4 | 171 | 103 | 23 | 14 |
| All trials | 681 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator and Lead sponsor of trials | 1996 to now |
| Organon | Applicant and Lead sponsor of trials | 2000 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2008 to now |
| Viatris | Acquired holder | 2020 to now |
| Cmp | Later holder | 2023 to now |