➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Johnson and Johnson
Medtronic
McKinsey
Dow

Last Updated: May 29, 2020

DrugPatentWatch Database Preview

Atorvastatin calcium - Generic Drug Details

» See Plans and Pricing

« Back to Dashboard

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, Mylan Pharms Inc, Sandoz Inc, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva Pharms, Teva Pharms Usa, Thepharmanetwork Llc, Zydus Pharms, Pfizer, Scov3, 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. Fifty-three 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
Assiut UniversityPhase 2
Mount Auburn HospitalPhase 2
Shandong UniversityPhase 4

See all atorvastatin calcium clinical trials

Recent Litigation for atorvastatin calcium

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 atorvastatin calcium litigation

Pharmacology for atorvastatin calcium
Medical Subject Heading (MeSH) Categories for atorvastatin calcium
Synonyms for atorvastatin calcium
(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 [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
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 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
Invagen Pharms ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 204846-003 Jan 9, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 090548-004 May 29, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 205519-002 May 19, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 205300-004 Mar 27, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Thepharmanetwork Llc ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 209288-003 Dec 21, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 207687-004 Mar 30, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms ATORVASTATIN CALCIUM atorvastatin calcium TABLET;ORAL 206536-001 Nov 20, 2018 AB RX 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 020702-004 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Johnson and Johnson
Medtronic
McKinsey
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.