NDAORALTABLET
Approved
Jul 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
4/8 — Partial
VYTORIN (ezetimibe and simvastatin) by Merck & Co. is hydroxymethylglutaryl-coa reductase inhibitors [moa]. First approved in 2004.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VYTORIN is a fixed-dose combination of ezetimibe (a dietary cholesterol absorption inhibitor) and simvastatin (an HMG-CoA reductase inhibitor) approved in 2004 for lowering LDL cholesterol and triglycerides in patients with hypercholesterolemia. It works through dual mechanism: blocking intestinal cholesterol absorption while simultaneously inhibiting hepatic cholesterol synthesis. The combination allows lower statin doses while achieving greater LDL reduction than monotherapy.
$5.0MPart D
LOE ApproachingStable
Product approaching loss of exclusivity with modest Medicare Part D utilization, suggesting mature brand with limited growth potential and likely right-sizing of commercial infrastructure.
Mechanism of Action
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Class:
Dietary Cholesterol Absorption Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes
Started Sep 2010
132 enrolled
Type 2 Diabetes Mellitus Without Insulin Treatment
The PostprAndial eNdothelial Function After Combination of Ezetimibe and simvAstatin Study
Started Apr 2009
100 enrolled
Metabolic Syndrome
Assessment of Interaction Between Vytorin and Niaspan in Healthy Subjects (P04955AM2)
Started May 2007
18 enrolled
HypercholesterolemiaHyperlipidemia
Clinical Trial of Zocor (Simvastatin) and Vytorin (Ezetimibe/Simvastatin) in Adolescents With Type 1 Diabetes
Started May 2007
9 enrolled
Type 1 Diabetes MellitusDyslipidemia
Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.
Started Mar 2007
30 enrolled
Metabolic Syndrome
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.