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simvastatin tablets
Simvastatin tablets, marketed by Federico II University, hold a position in the lipid-lowering market with a key composition patent expiring in 2028. The drug's primary strength lies in its well-established mechanism and indication, which have contributed to its widespread use. The primary risk is the potential increase in competition following the 2028 patent expiry.
At a glance
| Generic name | simvastatin tablets |
|---|---|
| Also known as | Simvastatin Krka 10 mg tablet, KRKA |
| Sponsor | Federico II University |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism (NA)
- Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis (EARLY_PHASE1)
- Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis (PHASE3)
- Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis (PHASE3)
- Antimicrobial and Anti-inflammatory Effects of Simvastatin as an Intracanal Medication (NA)
- Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC (PHASE1)
- A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants (PHASE1)
- Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC) (PHASE3)
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 |
|---|---|
| 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:
- simvastatin tablets CI brief — competitive landscape report
- simvastatin tablets updates RSS · CI watch RSS
- Federico II University portfolio CI