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XALKORI Drug Profile

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When do Xalkori patents expire, and what generic alternatives are available?

Xalkori is a drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and forty-four patent family members in forty-seven countries.

The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.

Summary for XALKORI

International Patents:	144
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	77
Clinical Trials:	30
Patent Applications:	133
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XALKORI
DailyMed Link:	XALKORI at DailyMed

Generic Entry Opportunity Date for XALKORI

NDA:

202570

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for XALKORI

Drug Class	Kinase Inhibitor
Mechanism of Action	Cytochrome P450 3A Inhibitors Receptor Tyrosine Kinase Inhibitors Cytochrome P450 2B6 Inhibitors P-Glycoprotein Inhibitors Organic Cation Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors

Synonyms for XALKORI

(R)-3-(1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(piperidin-4-yl)-1H-pyrazol-4-yl)pyridin-2-am ine

(R)-3-(1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(piperidin-4-yl)-1H-pyrazol-4-yl)pyridin-2-amine

(R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-2-ylamine

(R)-crizotinib

2-Pyridinamine, 3-((1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(4-piperidinyl)-1H-pyrazol-4-yl)-

2-PYRIDINAMINE, 3-[(1R)-1-(2,6-DICHLORO-3-FLUOROPHENYL)ETHOXY]-5-[1-(4-PIPERIDINYL)-1H-PYRAZOL-4-YL]-

3-((1r)-1-(2,6-dichloro-3-fluorophenyl)ethoxy)-5-(1-(4-piperidinyl)-1h-pyrazol-4-yl)pyridin-2-amine

3-(1R)-1-(2,6-Dichloro-3-fluorophenyl)ethoxy-5-1-(4-piperidinyl)-1H-pyrazol-4-yl-2-Pyridinamine

3-[(1r)-1-(2,6-Dichloro-3-Fluorophenyl)ethoxy]-5-(1-Piperidin-4-Yl-1h-Pyrazol-4-Yl)pyridin-2-Amine

3-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-[

3-[(1R)-1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-[1-(4-piperidinyl)-1H-pyrazol-4-yl]-2-pyridinamine

3-[(1R)-1-(2,6-DICHLORO-3-FLUOROPHENYL)ETHOXY]-5-[1-(4-PIPERIDINYL)-1H-PYRAZOL-4-YL]PYRIDIN-2-AMINE

3-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1H-pyrazol-4-yl]pyridin-2-amine

3-[(R)-1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-2-ylamine

399P525

53AH36668S

877399-52-5

877399-52-5, 877399-53-6 (acetate)

912279-98-2

AB0027203

ABP000131

AK172044

AKOS015901233

AKOS015995207

AMX10152

ANW-47749

AOB2688

BB 0261738

BC622990

BCPP000116

BDBM50306682

BRD-K78431006-001-01-1

C21H22Cl2FN5O

CHEBI:64310

CHEMBL601719

Crizotinib

Crizotinib (JAN/USAN/INN)

Crizotinib (PF-02341066)

Crizotinib (PF-2341066)

Crizotinib [USAN:INN]

Crizotinib, >=98% (HPLC)

crizotinibum

CTK5F8952

D03ZBT

D09731

DB08865

EN002685

EX-A096

FT-0665224

GS-6178

GTPL4903

HY-50878

I14-14837

J-510370

KB-26391

KIN0000318

KS-0000075X

KTEIFNKAUNYNJU-GFCCVEGCSA-N

MFCD12407409

MolPort-009-679-404

NCGC00250400-01

novel ALK inhibitors

NSC-749005

NSC749005

PB11015

PF 02341066

PF 2341066

PF 2341066;(R)-3-[1-(2,6-Dichloro-3-fluoro-phenyl)-ethoxy]-5-(1-piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-2-ylamine

PF-02341066

PF-02341066 (Crizotinib)

PF-2341066

PF-2341066 - Crizotinib

PF-2341066 (Crizotinib)

PF-2341066,Crizotinib

PF-2341066(Crizotinib)

PF2341066

PubChem19322

Q-3209

QCR-32

RL05464

SC-48062

SCHEMBL93829

SYN1139

TX-017903

UNII-53AH36668S

VGH

W9013

Xalkori (TN)

ZINC35902489

US Patents and Regulatory Information for XALKORI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes			Y	Y
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-001	Aug 26, 2011		RX	Yes	No
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes

International Patents for XALKORI

Country	Document Number	Estimated Expiration
Australia	2006323027
Argentina	056832
China	101326175
Japan	2008510790
Guatemala	200500225
Spain	2341351
Denmark	1603570

Supplementary Protection Certificates for XALKORI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1786785/01	Switzerland		PRODUCT NAME: CRIZOTINIB; REGISTRATION NO/DATE: SWISSMEDIC 62131 05.03.2012
90008-9	Sweden		PRODUCT NAME: CRIZOTINIB INKLUSIVE ETT FARMACEUTISKT GODTAGBART SALT, SOLVAT ELLER HYDRAT DAERAV; REG. NO/DATE: EU/1/12/793/001 20121023
2013005	Lithuania		PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
7 5008-2013	Slovakia		PRODUCT NAME: KRIZOTINIB; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
C0015	France		PRODUCT NAME: CRIZOTINIB ET SES SELS, HYDRATES ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/793/001 20121023
155	Luxembourg		PRODUCT NAME: CRIZOTINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE
0130007 00075	Estonia		PRODUCT NAME: KRISOTINIIB;REG NO/DATE: K(2012)7617 LOPLIK 23.10.2012