Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
McKesson
AstraZeneca
Johnson and Johnson
Express Scripts

Last Updated: December 9, 2019

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LIPITOR Drug Profile

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Which patents cover Lipitor, and what generic alternatives are available?

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. Sixty-four suppliers are listed for this compound. Additional details are available on the atorvastatin calcium profile page.

Drug patent expirations by year for LIPITOR
Drug Prices for LIPITOR

See drug prices for LIPITOR

Drug Sales Revenue Trends for LIPITOR

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Recent Clinical Trials for LIPITOR

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

SponsorPhase
Central Finland Hospital DistrictPhase 3
Kuopio University HospitalPhase 3
University of AarhusPhase 3

See all LIPITOR clinical trials

Recent Litigation for LIPITOR

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 LIPITOR litigation

Pharmacology for LIPITOR
Synonyms for LIPITOR
(|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
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 (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 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
>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 020702-003 Dec 17, 1996   Start Trial   Start Trial
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-003 Dec 17, 1996   Start Trial   Start Trial
Pfizer LIPITOR atorvastatin calcium TABLET;ORAL 020702-001 Dec 17, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Harvard Business School
AstraZeneca
Baxter
Johnson and Johnson
Express Scripts
Medtronic

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