PRAVACHOL
LOE ApproachingNDAORALTABLET
Approved
Oct 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
2/8 — Basic
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRAVACHOL (pravastatin) is an oral small-molecule statin approved in 1991 for lipid management and cardiovascular risk reduction. It works by inhibiting HMG-CoA reductase to lower LDL cholesterol and triglycerides. The product is indicated for patients with elevated cholesterol and those at risk for coronary heart disease.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team downsizing or transition planning on the brand.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Fed, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Subjects
Started Jul 2003
44 enrolled
Therapeutic Equivalency
Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects
Started Jun 2003
43 enrolled
Therapeutic Equivalency
Career Relevance
Working on PRAVACHOL in its LOE-approaching phase offers exposure to mature-product management, generic competition strategy, and market-access negotiations rather than launch excitement or expansion. This is a consolidation and optimization role, best suited for professionals seeking expertise in lifecycle management and cost-containment strategy.
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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.