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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 30^th, 2011.

Summary for LIPITOR

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	6
Bulk Api Vendors:	69
Clinical Trials:	193
Patent Applications:	4,492
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LIPITOR
Drug Sales Revenues:	Drug sales revenues for LIPITOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIPITOR
DailyMed Link:	LIPITOR at DailyMed

See drug prices for LIPITOR

See drug sales revenues for LIPITOR

Recent Clinical Trials for LIPITOR

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

Sponsor	Phase
National Institute on Aging (NIA)	Phase 4
Wake Forest University Health Sciences	Phase 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 Name	Date
SUMITOMO DAINIPPON PHARMA CO., LTD. v. EMCURE PHARMACEUTICALS LIMITED	2015-01-14
Pfizer Inc. v. Sandoz Inc.	2010-02-09
Pfizer Inc. v. Mylan Pharmaceuticals Inc.	2010-02-03

See all LIPITOR litigation

Pharmacology for LIPITOR

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

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
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000	AB	RX	Yes	Yes
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	AB	RX	Yes	No
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996	AB	RX	Yes	No

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
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-004	Apr 7, 2000
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-001	Dec 17, 1996
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996

International Patents for LIPITOR

Country	Patent Number	Estimated Expiration
Luxembourg	90147
Japan	H0358967
Philippines	26330
Slovenia	680963
Norway	309898
Mexico	9203095
Bulgaria	63630

Supplementary Protection Certificates for LIPITOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0247633	97C0118	France		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		PRODUCT NAME: AMLODIPIN + ATORVASTATIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57633 05.07.2006
1003503	SZ 30/2006	Austria		PRODUCT NAME: AMLODIPIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SÄUREADDITIONSALZ DESSELBEN IN KOMBINATION MIT ATORVASTATIN ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DESSELBEN
0720599	CR 2014 00050	Denmark		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		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		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		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