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Generated: April 20, 2018

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Pitavastatin calcium - Generic Drug Details

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

Pitavastatin calcium
is the generic ingredient in two branded drugs marketed by Kowa Co, Aurobindo Pharma Ltd, Orient Pharma Co Ltd, and Sawai Usa, and is included in four NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Pitavastatin calcium has fifty-eight patent family members in nineteen countries.

There are fifteen drug master file entries for pitavastatin calcium. One supplier is listed for this compound.
Pharmacology for pitavastatin calcium
Synonyms for pitavastatin calcium
( )-(3R,5S,6E)-7-(2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolyl)-3,5-dihydroxy-6-heptenoic acid
(+)-monocalciumbis{(3r,5s,6e)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-6-hepten
(3R,5S,6E)-7-(2-Cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid
(3R,5S,6E)-7-(2-Cyclopropyl-4-(p-fluorophenyl)-3-quinolyl)-3,5-dihydroxy-6-heptenoic acid
(3R,5S,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic Acid Calcium Salt
(3R,5S,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic acid hemicalcium salt
(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxy hept-6-enoic acid
(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate
(3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid
(3R,5S,E)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoate
(3R,5S,E)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoic acid
(3R,5S)-3,5-Dihydroxy-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-6-heptenoic acid
(E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoate
(E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-bis(oxidanyl)hept-6-enoate
(E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid
(E)-(3R,5S)-7-[2-Cyclopropyl-4-(4-fluoro-phenyl)-quinolin-3-yl]-3,5-dihydroxy-hept-6-enoic acid
(e)-(3r,5s)-7-[2-cyclopropyl-4-(4-fluoro-phenyl)-quinolin-3-yl]-3,5-dihydroxy-hept-6enoic acid
111GE002
1187847-92-2
121659-03-8
147511-69-1
147526-32-7
2299AH
2C25H23FNO4.Ca
3972AH
526P327
6-Heptenoic acid, 7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl)-3,5-dihydroxy-, (3R,5S,6E)-
6-Heptenoic acid, 7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl)-3,5-dihydroxy-, (S-(R*,S*-(E)))-
6-Heptenoic acid, 7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl)-3,5-dihydroxy-, calcium salt (2:1), (S-(R*,S*-(E)))-
6-Heptenoic acid, 7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl)-3,5-dihydroxy-,calcium salt (2:1), (3R,5S,6E)-
6-HEPTENOIC ACID, 7-[2-CYCLOPROPYL-4-(4-FLUOROPHENYL)-3-QUINOLINYL]-3,5-DIHYDROXY-, CALCIUM SALT (1:1), (3R,5S,6E)-
6-Heptenoic acid,7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-, (3R,5S,6E)-
A808653
AB01274731-01
AB2000276
AC1NR03G
AC1NR03J
ACT02718
AJ-26824
AK-50694
AKOS005145916
AKOS015900407
AKOS025311204
Alipza
AM84440
AM84441
AN-6862
API0003879
AT-3425
BC654789
BDBM50371229
BDBM86707
Bis((3R,5S,6E)-7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl)-3,5-dihydroxy-6-heptenoate) monocalcium salt
Bis((3R,5S,6E)-7-(2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl)-3,5-dihydroxy-6-heptenoate), monocalcium salt
BR-50694
C13334
C25H24FNO4
C50H46CaF2N2O8
Calcium (3R,5S,E)-7-(2-cyclopropyl-4-(4-fluorophenyl)-quinolin-3-yl)-3,5-dihydroxyhept-6-enoate
Calcium (3R,5S,E)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3,5-dihydroxyhept-6-enoate
calcium (E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)-3-quinolyl]-3,5-dihydroxy-hept-6-enoate
calcium (E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate
calcium;(E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate
calcium(2+) bis((3R,5S,6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoate)
CAS_147511-69-1
CCG-101142
CCG-230641
CCRIS 8652
CHEBI:32020
CHEBI:71258
CHEBI:71260
CHEBI:94569
CHEMBL1201753
CHEMBL1237061
CJ-24282
CP0140
CPD000469287
CPD004727569
CS-2110
D01862
D0G1WL
D0H9WN
DB08860
DTXSID1048384
DTXSID4046448
E-(3R,5S)-7-[2-Cyclopropyl-4-(4fluoro-phenyl)quinolin-3-yl]-3,5-dihydroxy-hept-6-enoic acid
Flovas
GTPL3035
HE069357
HE312633
HMS2052O19
HMS3264F17
HSDB 8367
HY-B0144A
Itavastatin
ITAVASTATIN Ca
Itavastatin calcium
Itavastatin|||Nisvastatin|||NK-104|||P-872441|||(E,3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxyhept-6-enoic acid
Itavastin
IYD54XEG3W
KS-1220
Livalo
Livalo (TN)
Livazo
LS-190698
LS-74594
LS-74595
M5681Q5F9P
MFCD01937979
MLS001401466
MLS006010096
MolPort-003-987-536
MolPort-006-822-984
NC00392
Nisvastatin
NK 104
NK 104 (acid)
NK-104
NKS-104
NSC-760423
NSC760423
P 872441
P-872441
Pharmakon1600-01502374
Pitava
Pitava 1
pitavastatia
Pitavastatin
Pitavastatin [INN]
Pitavastatin calcium (JAN)
Pitavastatin calcium /NK-104
pitavastatin calcium hydrate
Pitavastatin calcium salt
Pitavastatin CalciumDISCONTINUED
pitavastatin cation
Pitavastatin hemicalcium
pitavastatin(1-)
pitavastatine
pitavastatinum
Q-201590
Redevant
RHGYHLPFVJEAOC-FFNUKLMVSA-L
SAM001246803
SC-18906
SCHEMBL15476618
SCHEMBL22720
SCHEMBL3369
SCHEMBL464781
SMR000469287
SMR003965244
ST24030237
TL8006181
UNII-IYD54XEG3W
UNII-M5681Q5F9P
VGYFMXBACGZSIL-MCBHFWOFSA-N
ZINC1534965
Zypitamag

US Patents and Regulatory Information for pitavastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206015-002 Dec 20, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd PITAVASTATIN CALCIUM pitavastatin calcium TABLET;ORAL 206015-003 Dec 20, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for pitavastatin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 ➤ Sign Up ➤ Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-003 Aug 3, 2009 ➤ Sign Up ➤ Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-001 Aug 3, 2009 ➤ Sign Up ➤ Sign Up
Kowa Co LIVALO pitavastatin calcium TABLET;ORAL 022363-002 Aug 3, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for pitavastatin calcium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,185,328 Quinoline type mevalonolactones useful for treating hyperlipidemia, hyperlipoproteinemia or atherosclerosis ➤ Sign Up
5,854,259 Quinoline type mevalonolactones ➤ Sign Up
5,872,130 Quinoline type mevalonoactones ➤ Sign Up
5,011,930 Quinoline type mevalonolactones ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Farmers Insurance
AstraZeneca
Medtronic
Covington
McKesson
Chinese Patent Office
Federal Trade Commission

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