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Last Updated: March 3, 2021

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LIPITOR Drug Profile

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When do Lipitor patents expire, and when can generic versions of Lipitor launch?

Lipitor is a drug marketed by Upjohn and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Lipitor

A generic version of LIPITOR was approved as atorvastatin calcium by SUN PHARM INDS LTD on November 30th, 2011.

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Drug patent expirations by year for LIPITOR
Drug Prices for LIPITOR

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Drug Sales Revenue Trends for LIPITOR

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Recent Clinical Trials for LIPITOR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AmgenPhase 4
Brigham and Women's HospitalPhase 4
Wake Forest University Health SciencesPhase 4

See all LIPITOR clinical trials

Pharmacology for LIPITOR
Paragraph IV (Patent) Challenges for LIPITOR
Tradename Dosage Ingredient NDA Submissiondate
LIPITOR TABLET;ORAL atorvastatin calcium 020702

US Patents and Regulatory Information for LIPITOR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Upjohn LIPITOR atorvastatin calcium TABLET;ORAL 020702-001 Dec 17, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
Upjohn LIPITOR atorvastatin calcium TABLET;ORAL 020702-004 Apr 7, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Upjohn LIPITOR atorvastatin calcium TABLET;ORAL 020702-002 Dec 17, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
Upjohn LIPITOR atorvastatin calcium TABLET;ORAL 020702-003 Dec 17, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LIPITOR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn LIPITOR atorvastatin calcium TABLET;ORAL 020702-004 Apr 7, 2000   Start Trial   Start Trial
Upjohn LIPITOR atorvastatin calcium TABLET;ORAL 020702-003 Dec 17, 1996   Start Trial   Start Trial
Upjohn LIPITOR atorvastatin calcium TABLET;ORAL 020702-003 Dec 17, 1996   Start Trial   Start Trial
Upjohn LIPITOR atorvastatin calcium TABLET;ORAL 020702-002 Dec 17, 1996   Start Trial   Start Trial
Upjohn LIPITOR atorvastatin calcium TABLET;ORAL 020702-001 Dec 17, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LIPITOR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0720599 CR 2014 00050 Denmark   Start Trial PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
0247633 97C0118 France   Start Trial PRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107
0247633 SPC/GB97/011 United Kingdom   Start Trial SPC/GB97/011: 20070529, EXPIRES: 20111106
1003503 SZ 30/2006 Austria   Start Trial PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN
0247633 97C0103 Belgium   Start Trial PRODUCT NAME: CALCII ATORVASTATINUM TRIHYDRICUM (=ATORVASTATINUM); NAT. REGISTRATION NO/DATE: 19 IS 95 F 3 19970922; FIRST REGISTRATION: GB PL/00018/0240 19961107
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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