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LIPITOR Drug Profile

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Lipitor is a drug marketed by Pfizer and is included in one NDA. It is available from eleven suppliers. There is one patent protecting this drug.

This drug has sixty-four patent family members in thirty-six countries.

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

Summary for Tradename: LIPITOR

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list11

Pharmacology for Tradename: LIPITOR

Clinical Trials for: LIPITOR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-001Dec 17, 1996RXNo5,969,156*PED<disabled>Y<disabled>
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-004Apr 7, 2000RXYes5,969,156*PED<disabled>Y<disabled>
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-002Dec 17, 1996RXNo5,969,156*PED<disabled>Y<disabled>
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Expired Patents for Tradename: LIPITOR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-003Dec 17, 19964,681,893*PED<disabled>
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-001Dec 17, 19965,686,104*PED<disabled>
Pfizer
LIPITOR
atorvastatin calcium
TABLET;ORAL020702-002Dec 17, 1996RE40667*PED<disabled>
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International Patent Family for Tradename: LIPITOR

Country Document Number Estimated Expiration
Israel128864<disabled in preview>
Colombia4700443<disabled in preview>
Japan3296564<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LIPITOR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0118France<disabled>PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107
/2006Austria<disabled>PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN; NAT. REGISTRATION NO/DATE: 1-26271, 1-26273 20060330; FIRST REGISTRATION: FR 369300.9;369301.5; 369302.1;369303.8;369304.4;369305.0; 20050707
/1997Austria<disabled>PRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
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