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Cipla
US Department of Justice

Generated: August 16, 2018

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LIVALO Drug Profile

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When do Livalo patents expire, and when can generic versions of Livalo launch?

Livalo is a drug marketed by Kowa Co and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-eight patent family members in nineteen countries.

The generic ingredient in LIVALO is pitavastatin calcium. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pitavastatin calcium profile page.

Drug patent expirations by year for LIVALO
Pharmacology for LIVALO
Synonyms for LIVALO
( )-(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
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-, (3R,5S,6E)-
A808653
AB01274731-01
AB2000276
AC1NR03G
AC1NR03J
ACT02718
AJ-26824
AK-50694
AKOS005145916
AKOS015900407
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
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
CCRIS 8652
CHEBI:32020
CHEBI:71258
CHEBI:71260
CHEBI:94569
CHEMBL1201753
CHEMBL1237061
CJ-24282
CS-2110
D01862
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
HE312633
HSDB 8367
HY-B0144A
Itavastatin
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 (TN)
Livazo
LS-190698
LS-74594
LS-74595
M5681Q5F9P
MFCD01937979
MLS006010096
MolPort-006-822-984
Nisvastatin
NK 104
NK 104 (acid)
NK-104
NKS-104
P 872441
P-872441
Pitava
Pitava 1
pitavastatia
Pitavastatin
Pitavastatin [INN]
Pitavastatin calcium
Pitavastatin calcium (JAN)
pitavastatin calcium hydrate
Pitavastatin calcium salt
Pitavastatin CalciumDISCONTINUED
pitavastatin cation
Pitavastatin hemicalcium
pitavastatin(1-)
pitavastatine
pitavastatinum
Q-201590
Redevant
RHGYHLPFVJEAOC-FFNUKLMVSA-L
SC-18906
SCHEMBL22720
SCHEMBL3369
SCHEMBL464781
SMR003965244
ST24030237
UNII-IYD54XEG3W
UNII-M5681Q5F9P
VGYFMXBACGZSIL-MCBHFWOFSA-N
ZINC1534965
Zypitamag

US Patents and Regulatory Information for LIVALO

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 022363-003 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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Paragraph IV (Patent) Challenges for LIVALO
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 1 mg, 2 mg, and 4 mg ➤ Subscribe ➤ Sign Up

Non-Orange Book US Patents for LIVALO

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
7,776,881 Hyperlipemia therapeutic agent ➤ Sign Up
5,011,930 Quinoline type mevalonolactones ➤ Sign Up
8,853,405 Crystalline forms of pitavastatin calcium ➤ Sign Up
5,185,328 Quinoline type mevalonolactones useful for treating hyperlipidemia, hyperlipoproteinemia or atherosclerosis ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Merck
Baxter
Chinese Patent Office
Colorcon
Covington
QuintilesIMS
Express Scripts
AstraZeneca

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