NDAORALTABLET, EXTENDED RELEASE
Approved
Jun 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
5/8 — Partial
ALTOPREV (lovastatin) by Merck & Co. is clinical pharmacology the involvement of low-density lipoprotein cholesterol (ldl-c) in atherogenesis has been well-documented in clinical and pathological studies, as well as in many animal experiments. Approved for hypercholesterolemia, cardiovascular disease, coronary artery disease and 1 more indications. First approved in 2002.
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALTOPREV is an extended-release oral tablet formulation of lovastatin, a statin that inhibits HMG-CoA reductase to reduce LDL cholesterol and treat hypercholesterolemia and cardiovascular disease. It works by reducing VLDL production and inducing LDL receptors, leading to decreased cholesterol biosynthesis. The drug is indicated for hypercholesterolemia, coronary artery disease, atherosclerosis, and several rare conditions including cerebrotendinous xanthomatosis and neurofibromatosis type 1.
$762KPart D
LOE ApproachingDeclining
Minimal team investment expected as product approaches loss of exclusivity with very low Part D utilization indicating market erosion to generics.
Mechanism of Action
CLINICAL PHARMACOLOGY The involvement of low-density lipoprotein cholesterol (LDL-C) in atherogenesis has been well-documented in clinical and pathological studies, as well as in many animal experiments. Epidemiological and clinical studies have established that high LDL-C and low high-density…
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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.