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ROSUVASTATIN
Rosuvastatin, a marketed drug primarily indicated to reduce cardiovascular events, holds a significant position in the lipid-lowering market. Its key strength lies in the robust clinical evidence supporting its efficacy in reducing CV events, which differentiates it from competitors. The primary risk is the upcoming key composition patent expiry in 2028, which could lead to increased generic competition and potential revenue erosion.
At a glance
| Generic name | ROSUVASTATIN |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2003 |
Approved indications
- Reduce CV events
- Reduce LDL-C in primary hyperlipidemia
- Reduce LDL-C and slow atherosclerosis
- Reduce LDL-C in HeFH
- Reduce LDL-C in HoFH
- Treat primary dysbetalipoproteinemia
- Treat hypertriglyceridemia
Common side effects
- Headache
- Nausea
- Myalgia
- Asthenia
- Constipation
- Abdominal pain
- Dizziness
- Rash
- Pruritus
- Urticaria
Serious adverse events
- Rhabdomyolysis
- Myopathy
- Immune-Mediated Necrotizing Myopathy
- Hepatic Dysfunction
- Pancreatitis
- Angioedema
- Proteinuria
- Hematuria
Drug interactions
- Cyclosporine
- Teriflunomide
- Enasidenib
- Capmatinib
- Fostamatinib
- Febuxostat
- Gemfibrozil
Key clinical trials
- Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants (PHASE1)
- Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib (PHASE1)
- A Clinical Study of the Effect of MK-2828 on Rosuvastatin or Furosemide in Healthy People (MK-2828-005) (PHASE1)
- Polygenic Risk-based Detection of Subclinical Coronary Atherosclerosis and Intervention With Statin and Colchicine (PHASE4)
- A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037) (PHASE3)
- A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events (PHASE3)
- A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039) (PHASE1)
- A Study to Investigate the Effect of AZD0780 Tablets in Combination With Rosuvastatin Tablets on Low Density Lipoprotein Cholesterol Levels (LDL-C) in Adult Participants With Dyslipidaemia (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ROSUVASTATIN CI brief — competitive landscape report
- ROSUVASTATIN updates RSS · CI watch RSS