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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.

Summary for pitavastatin calcium

International Patents:	58
US Patents:	3
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	15
Suppliers / Packagers:	1
Bulk Api Vendors:	86
Clinical Trials:	1
Patent Applications:	6,391
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pitavastatin calcium
DailyMed Link:	pitavastatin calcium at DailyMed

Pharmacology for pitavastatin calcium

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

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	206015-001	Dec 20, 2016	AB	RX	No	No
Aurobindo Pharma Ltd	PITAVASTATIN CALCIUM	pitavastatin calcium	TABLET;ORAL	206015-002	Dec 20, 2016	AB	RX	No	No
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	AB	RX	Yes	No			Y
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009	AB	RX	Yes	No

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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	022363-002	Aug 3, 2009
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-003	Aug 3, 2009
Kowa Co	LIVALO	pitavastatin calcium	TABLET;ORAL	022363-001	Aug 3, 2009

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
5,011,930	Quinoline type mevalonolactones
5,102,888	Quinoline type mevalonolactones useful for treating hyperlipidemia and related diseases
5,185,328	Quinoline type mevalonolactones useful for treating hyperlipidemia, hyperlipoproteinemia or atherosclerosis
5,854,259	Quinoline type mevalonolactones

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International Patents for pitavastatin calcium

Country	Document Number	Estimated Expiration
Japan	2015172086
Japan	5445713
Slovenia	1715865
Canada	2513837