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Generated: November 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020702

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NDA 020702 describes LIPITOR, which is a drug marketed by Pfizer and is included in one NDA. It is available from thirteen suppliers. Additional details are available on the LIPITOR profile page.

The generic ingredient in LIPITOR is atorvastatin calcium. There are sixty-two drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.
Summary for 020702
Tradename:LIPITOR
Applicant:Pfizer
Ingredient:atorvastatin calcium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020702
Medical Subject Heading (MeSH) Categories for 020702
Suppliers and Packaging for NDA: 020702
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIPITOR atorvastatin calcium TABLET;ORAL 020702 NDA Parke-Davis Div of Pfizer Inc 0071-0155 0071-0155-10 1000 TABLET, FILM COATED in 1 BOTTLE (0071-0155-10)
LIPITOR atorvastatin calcium TABLET;ORAL 020702 NDA Parke-Davis Div of Pfizer Inc 0071-0155 0071-0155-23 90 TABLET, FILM COATED in 1 BOTTLE (0071-0155-23)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Dec 17, 1996TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jun 23, 2020
Regulatory Exclusivity Use:CLINICAL INFORMATION ADDED TO THE PACKAGE INSERT REGARDING USE OF ATORVASTATIN IN CHILDREN AND ADOLESCENTS AGES 10-17 WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Dec 17, 1996TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Jun 23, 2020
Regulatory Exclusivity Use:CLINICAL INFORMATION ADDED TO THE PACKAGE INSERT REGARDING USE OF ATORVASTATIN IN CHILDREN AND ADOLESCENTS AGES 10-17 WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HEFH)

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Dec 17, 1996TE:ABRLD:Yes

Expired US Patents for NDA 020702

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-001 Dec 17, 1996 ➤ Sign Up ➤ Sign Up
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-004 Apr 7, 2000 ➤ Sign Up ➤ Sign Up
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-004 Apr 7, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
McKinsey
Dow
Baxter
Cerilliant
Cantor Fitzgerald
Medtronic
Accenture

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