NDAORALTABLET, EXTENDED RELEASE
Approved
Oct 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
LESCOL XL (fluvastatin sodium) by Novartis is hmg-coa reductase, the rate limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme a (hmg-coa) to mevalonate, a precursor of cholesterol. First approved in 2000.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LESCOL XL is an extended-release oral tablet containing fluvastatin sodium, a statin that inhibits HMG-CoA reductase to lower cholesterol synthesis. It is indicated for patients with elevated cholesterol levels requiring cardiovascular risk reduction. The drug works by blocking the rate-limiting enzyme in cholesterol production, effectively reducing LDL cholesterol and triglycerides.
$0.7MPart D
LOE ApproachingDeclining
With LOE approaching and minimal Part D claims (~900 in 2023), the brand team is likely in defend-and-harvest mode with reduced headcount and portfolio focus shifting to pipeline assets.
Mechanism of Action
HMG-CoA reductase, the rate limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) to mevalonate, a precursor of cholesterol.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Efficacy and Safety of Fluvastatin Sodium Extended Release Tablets 80 mg Once Daily in Chinese Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
Started Jan 2012
436 enrolled
Lipid Metabolism Disorders
Career Relevance
Working on LESCOL XL offers limited career advancement due to its approaching loss of exclusivity, minimal market claims (906 Part D claims in 2023), and zero linked job openings. Assignment to this product typically signals a mid-career or defensive role rather than a growth opportunity, making it a potential career plateau or stepping stone to higher-impact franchises.
Brand Manager
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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.