NDAORALTABLETPriority Review
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
17
Data completeness
5/8 — Partial
Priority Review
LIPITOR (atorvastatin calcium) by Viatris (2) is selective, competitive inhibitor of hmg-coa reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme a to mevalonate, a precursor of sterols, including cholesterol. First approved in 1996.
Drug data last refreshed 6h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIPITOR (atorvastatin calcium) is an oral statin tablet that selectively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis. It reduces LDL cholesterol and lipoprotein levels by blocking hepatic cholesterol production and increasing LDL receptor uptake. The drug is indicated for hyperlipidemia and cardiovascular risk reduction in patients at risk of coronary heart disease.
$33MPart D
LOE ApproachingAs loss of exclusivity approaches, the brand team is transitioning from growth-focused to defensive strategies; team size may contract as generic competition intensifies.
Mechanism of Action
selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol. In animal models, LIPITOR lowers plasma cholesterol and lipoprotein levels by inhibiting HMG-CoA…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (17)
Bioequivalence Study Between "Dong-A Atorvastatin Tab" and "Lipitor Tab"
Started Mar 2020
56 enrolled
Healthy
Actual Use Trial of Atorvastatin Calcium 10 mg
Started Oct 2013
1,311 enrolled
Hypercholesterolemia
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fasting Condition
Started Oct 2011
80 enrolled
Healthy
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition
Started Sep 2011
90 enrolled
Healthy
Special Drug Use-Results Survey of Lipitor Tablets
Started Sep 2010
24,050 enrolled
Hypercholesterolemia
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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.