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Atorvastatin calcium - Generic Drug Details

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What are the generic drug sources for atorvastatin calcium and what is the scope of atorvastatin calcium patent protection?

Atorvastatin calcium is the generic ingredient in four branded drugs marketed by Accord Hlthcare, Apotex Inc, Dr Reddys Labs Ltd, Graviti Pharms, Invagen Pharms, Lannett Co Inc, Mylan Pharms Inc, Sandoz Inc, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Usa, Pfizer, Watson Labs Teva, and Merck Sharp Dohme, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-two drug master file entries for atorvastatin calcium. Sixty-four suppliers are listed for this compound.

Summary for atorvastatin calcium

US Patents:	0
Tradenames:	4
Applicants:	15
NDAs:	16
Drug Master File Entries:	62
Suppliers / Packagers:	64
Bulk Api Vendors:	62
Clinical Trials:	39
Patent Applications:	7,644
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for atorvastatin calcium
DailyMed Link:	atorvastatin calcium at DailyMed

Pharmacology for atorvastatin calcium

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

Medical Subject Heading (MeSH) Categories for atorvastatin calcium

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Synonyms for atorvastatin calcium

(|AR,|AR)-2-(4-Fluorophenyl)-|A,|A-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid Calcium Salt

(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

1108202-55-6

110862-48-1 (Parent)

134523-03-8

1370463-14-1

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*))-

2C33H34FN2O5.Ca

334757-04-9

4CA-0208

AC1L1TZQ

ACT03226

AK106989

AKOS015896435

AM90286

AN-6412

AOB6343

AT-3134

Atorvastan

Atorvastatin calcium [USAN:USP]

Atorvastatin calcium [USAN]

Atorvastatin calcium anhydorous

Atorvastatin calcium anhydrous

Atorvastatin calcium salt

Atorvastatin Hemicalcium

Atorvastatin hemicalcium salt

BB_SC-4721

BC634906

BDBM50442868

C0GEJ5QCSO

CA0146

calcium (3R,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-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

calcium (3R,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrol-1-yl]-3,5-dihydroxy-heptanoate

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-[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

HE307391

I06-1867

J-006551

KB-270796

Kolevas

KS-00000IS3

Lipibec

Lipitor

LS-136974

MFCD00899261

MolPort-003-986-383

NCGC00159458-03

NCGC00159458-05

NCGC00255845-01

PD 134298-38A

Prevencor

Ranbaxy's Storvas

Rotacor

SC-76963

SCHEMBL3832

Sortis

Storvas

SYN3020

Tahor

TL8000809

Torvast

Tox21_111685

Tox21_111685_1

Tox21_302373

UNII-C0GEJ5QCSO

VA10343

YM 548

YM-548

US Patents and Regulatory Information for atorvastatin calcium

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	020702-003	Dec 17, 1996	AB	RX	Yes	No
Watson Labs Teva	EZETIMIBE AND ATORVASTATIN CALCIUM	atorvastatin calcium; ezetimibe	TABLET;ORAL	206084-003	Apr 26, 2017		RX	No	No
Teva Pharms Usa	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	205300-004	Mar 27, 2017	AB	RX	No	No
Sun Pharm Inds Ltd	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	076477-003	Nov 30, 2011	AB	RX	No	No
Sciegen Pharms Inc	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	205519-001	May 19, 2016	AB	RX	No	No
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-002	Dec 17, 1996	AB	RX	Yes	No
Sandoz Inc	ATORVASTATIN CALCIUM	atorvastatin calcium	TABLET;ORAL	077575-003	May 29, 2012	AB	RX	No	No

Expired US Patents for atorvastatin calcium

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	020702-002	Dec 17, 1996
Pfizer	LIPITOR	atorvastatin calcium	TABLET;ORAL	020702-003	Dec 17, 1996
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