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Last Updated: January 18, 2020

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Atorvastatin calcium - Generic Drug Details

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What are the generic sources for atorvastatin calcium and what is the scope of freedom to operate?

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, Lupin Ltd, Micro Labs Ltd India, Msn Labs Pvt Ltd, Mylan Pharms Inc, Sandoz Inc, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Usa, Thepharmanetwork Llc, Zydus Pharms, Pfizer, Watson Labs Teva, and Merck Sharp Dohme, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Sales Revenue Trends for atorvastatin calcium

See drug sales revenues for atorvastatin calcium

Recent Clinical Trials for atorvastatin calcium

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

SponsorPhase
General Hospital of Shenyang Military RegionPhase 4
Sun Yat-sen UniversityPhase 4
Jun TaoPhase 4

See all atorvastatin calcium clinical trials

Recent Litigation for atorvastatin calcium

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc. v. Sandoz Inc.2010-02-09
Pfizer Inc. v. Mylan Pharmaceuticals Inc.2010-02-03
MERCK SHARP & DOHME CORP. v. MYLAN PHARMACEUTICALS INC.2009-12-16

See all atorvastatin calcium litigation

Pharmacology for atorvastatin calcium
Medical Subject Heading (MeSH) Categories for atorvastatin calcium
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
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*))-
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
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
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
I06-1867
J-006551
KB-270796
Kolevas
KS-00000IS3
Lipibec
Lipitor
Lipitor (TN)
Liprimar
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
SW219144-1
SYN3020
Tahor
TL8000809
Torvast
Tox21_111685
Tox21_111685_1
Tox21_302373
Tulip
UNII-C0GEJ5QCSO
VA10343
YM 548
YM-548
Paragraph IV (Patent) Challenges for ATORVASTATIN CALCIUM
Tradename Dosage Ingredient NDA Submissiondate
LIPITOR TABLET;ORAL atorvastatin calcium 020702

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
Watson Labs Teva EZETIMIBE AND ATORVASTATIN CALCIUM atorvastatin calcium; ezetimibe TABLET;ORAL 206084-001 Apr 26, 2017 RX No No   Start Trial   Start Trial   Start Trial
Msn Labs Pvt Ltd ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 211933-002 Feb 8, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 204991-003 Mar 6, 2019 DISCN No 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 atorvastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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

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