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Profile for Tradename: LIPITOR

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Lipitor is a drug marketed by Pfizer and is included in one NDA. It is available from eighteen suppliers. There are two patents protecting this drug.

The generic ingredient in LIPITOR is atorvastatin calcium. There are fifty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.

Summary for Tradename: LIPITOR

Suppliers / Packagers: see list146

Pharmacology for Tradename: LIPITOR

Clinical Trials for: LIPITOR

CKD-391 DDI : Atorvastatin and Ezetimibe in Healthy Volunteers
Status: Completed Condition: Healthy

LIpitor and biGuanide to Androgen Delay Trial
Status: Not yet recruiting Condition: Prostate Cancer

High Dose and Low Dose of Atorvastatin in Patients With Unstable Angina and NSTEMI (Non ST Elevation MI)
Status: Completed Condition: Cardiovascular Disease

A Study to Determine the Bioequivalence of SCH 900068 Compared to Marketed Products (Protocol No. P07551)
Status: Completed Condition: Hyperlipidemia

Atorvastatin for HAART Suboptimal Responders
Status: Completed Condition: Acquired Immune Deficiency Syndrome Virus

Effect of Atorvastatin on Endothelial Dysfunction and Albuminuria in Sickle Cell Disease
Status: Enrolling by invitation Condition: Sickle Cell Disease; Sickle Cell Nephropathy

Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus
Status: Terminated Condition: Avascular Necrosis

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin
Status: Completed Condition: Dyslipidaemias

Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Under Fed Conditions
Status: Completed Condition: Healthy

The Effect of Atorvastatin and Pioglitazone on Carotid Atherosclerosis With the Use of Positron Emission Tomography-computed Tomography (PET-CT)
Status: Completed Condition: Atherosclerosis; Coronary Artery Disease

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See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
atorvastatin calcium
TABLET;ORAL020702-001Dec 17, 1996RXNo5,969,156*PED<disabled>Y<disabled>
atorvastatin calcium
TABLET;ORAL020702-004Apr 7, 2000RXYes5,969,156*PED<disabled>Y<disabled>
atorvastatin calcium
TABLET;ORAL020702-002Dec 17, 1996RXNo5,686,104*PED<disabled>Y<disabled>
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Non-Orange Book Patents for Tradename: LIPITOR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,126,971 Stable oral CI-981 formulation and process for preparing same<disabled in preview>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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