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 Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Lipitor (atorvastatin calcium) is an oral HMG-CoA reductase inhibitor (statin) approved in 1996 for type 2 diabetes mellitus management. It works by selectively inhibiting HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol production and increasing hepatic LDL receptor expression to enhance cholesterol clearance. Lipitor is a foundational lipid-lowering therapy widely used in cardiovascular risk reduction, though it now faces substantial generic competition and is approaching loss of exclusivity.
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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.