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Last Updated: May 26, 2020

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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 Pfizer 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
National Institute on Aging (NIA)Phase 4
Wake Forest University Health SciencesPhase 4
Dong-A ST Co., Ltd.Phase 1

See all LIPITOR clinical trials

Recent Litigation for LIPITOR

Identify potential future generic entrants

District Court Litigation
Case NameDate
SUMITOMO DAINIPPON PHARMA CO., LTD. v. EMCURE PHARMACEUTICALS LIMITED2015-01-14
Pfizer Inc. v. Sandoz Inc.2010-02-09
Pfizer Inc. v. Mylan Pharmaceuticals Inc.2010-02-03

See all LIPITOR litigation

Pharmacology for LIPITOR
Synonyms for LIPITOR
(C33H34FN2O5)2.Ca
(R,R)-2-(4-Fluorophenyl)-?,?-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemicalcium salt
[R-(R*, R*)]-2-(4-fluorophenyl)-(beta), (delta)-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid, calcium salt (2:1) trihydrate
[R-(R*, R*)]-2-(4-fluorophenyl)-beta-, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid,calcium salt (2:1) trihydrate
110862-48-1
134523-03-8
1H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)-,-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-, calcium salt (2:1), (R,R)-
1H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-((phenylamino)carbonyl)-, calcium salt (2:1), (R-(R*,R*))-
1H-Pyrrole-1-heptanoic acid, beta,delta-dihydroxy-2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-((phenylamino)carbonyl)-, calcium salt (2:1), (R-(R*,R*))-
1H-Pyrrole-1-heptanoicacid,2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-,calciumsalt(2:1),(betaR,deltaR)-
2C33H34FN2O5.Ca
4CA-0208
ACT03226
AK106989
AKOS015896435
AM90286
AOB6343
AT-3134
Atorvastan
ATORVASTATIN CALCIUM
Atorvastatin calcium [USAN:USP]
Atorvastatin calcium [USAN]
Atorvastatin calcium anhydorous
Atorvastatin calcium anhydrous
Atorvastatin calcium hydrate
Atorvastatin calcium salt
Atorvastatin calcium salt anhydrous
Atorvastatin calcium salt trihydrate
Atorvastatin Hemicalcium
Atorvastatin hemicalcium salt
atorvastatin-calcium-lipitor
BDBM50442868
C0GEJ5QCSO
CA0146
calcium (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate
Calcium (betaR,deltaR)-2-(p-fluorophenyl)-beta,delta-dihydroxy-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrole-1-heptanoate (1:2)
calcium bis((3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate)
Calcium bis{(3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate}
calcium bis{(3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate}
calcium;(3R,5R)-7-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-propan-2-ylpyrrol-1-yl]-3,5-dihydroxyheptanoate
CAS-134523-03-8
CHEBI:50686
CHEMBL393220
CI 981
CI-981
D00887
DRG-0321
DSSTox_CID_24303
DSSTox_GSID_44303
DSSTox_RID_80143
DTXSID6044303
FQCKMBLVYCEXJB-MNSAWQCASA-L
FT-0081085
GS-3563
J-006551
Kolevas
KS-00000IS3
Lipibec
Lipitor (TN)
Lipitor; Atorvastatin calcium
Liprimar
LS-136974
MFCD00899261
NCGC00159458-03
NCGC00159458-05
NCGC00255845-01
PD 134298-38A
Prevencor
Q27888052
Ranbaxy's Storvas
Rotacor
SC-76963
SCHEMBL3832
Sortis
Sotis
Storvas
SW219144-1
SYN3020
Tahor
Torvast
Tox21_111685
Tox21_111685_1
Tox21_302373
Tulip
UNII-C0GEJ5QCSO
VA10343
YM 548
YM-548
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
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-001 Dec 17, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-004 Apr 7, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-002 Dec 17, 1996 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer 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
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-004 Apr 7, 2000   Start Trial   Start Trial
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-004 Apr 7, 2000   Start Trial   Start Trial
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-002 Dec 17, 1996   Start Trial   Start Trial
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-001 Dec 17, 1996   Start Trial   Start Trial
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-001 Dec 17, 1996   Start Trial   Start Trial
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-002 Dec 17, 1996   Start Trial   Start Trial
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-003 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
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
1003503 C01003503/01 Switzerland   Start Trial PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
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
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 C970034 Netherlands   Start Trial PRODUCT NAME: ATORVASTATINUM,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF VAN HET INWENDIGE DELTA-LACTON, IN HET BIJZONDER ATORVASTATINUM CALCICUM TRIHYDRICUM; NAT. REGISTRATION NO/DATE: RVG 21081 - RVG 21083 19970421; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
0720599 92545 Luxembourg   Start Trial PRODUCT NAME: EZETIMIBE EN COMBINAISON AVEC ATORVASTATINE OU LEURS SELS PHARMACEUTIQUEMENT ACCEPTEES, Y COMPRIS ATORVASTATINE SOUS FORME D'ATORVASTATINE CALCIQUE TRIHYDRATEE; FIRST REGISTRATION: 20140910
0720599 300689 Netherlands   Start Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Merck
Moodys
Boehringer Ingelheim
Mallinckrodt

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