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XALKORI Drug Profile

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

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-eight 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.

US ANDA Litigation and Generic Entry Outlook for Xalkori

Xalkori was eligible for patent challenges on August 26^th, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 6^th, 2029. This may change due to patent challenges or generic licensing.

Summary for XALKORI

International Patents:	148
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	79
Clinical Trials:	34
Patent Applications:	165
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XALKORI
DailyMed Link:	XALKORI at DailyMed

See drug prices for XALKORI

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.

Recent Clinical Trials for XALKORI

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

Sponsor	Phase
University Health Network, Toronto	Phase 2
Federal Research Institute of Pediatric Hematology, Oncology and Immunology	Phase 2/Phase 3
Pfizer	Phase 4

See all XALKORI clinical trials

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)-

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

BRD-K78431006-001-03-7

C21H22Cl2FN5O

CHEBI:64310

CHEMBL601719

Crizotinib

Crizotinib (JAN/USAN/INN)

Crizotinib (PF-02341066)

Crizotinib (PF-2341066)

Crizotinib [USAN:INN]

Crizotinib, >=98% (HPLC)

Crizotinib; PF 2341066

crizotinibum

CTK5F8952

D09731

DB08865

EN002685

EX-A096

FT-0665224

GS-6178

GTPL4903

HY-50878

I14-14837

J-510370

KB-26391

KIN0000318

KS-0000075X

KTEIFNKAUNYNJU-GFCCVEGCSA-N

MolPort-009-679-404

NCGC00250400-01

NCGC00250400-09

NCGC00250400-12

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

SW202555-3

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	202570-002	Aug 26, 2011		RX	Yes	Yes
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
Pf Prism Cv	XALKORI	crizotinib	CAPSULE;ORAL	202570-002	Aug 26, 2011		RX	Yes	Yes			Y	Y

International Patents for XALKORI

Country	Patent Number	Estimated Expiration
South Korea	100859891
Panama	8643301
Argentina	099982
Israel	191471
New Zealand	552866

Supplementary Protection Certificates for XALKORI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1786785	2013C/021	Belgium		PRODUCT NAME: CRIZOTINIB; AUTHORISATION NUMBER AND DATE: EU/1/12/793/001 20121026
1786785	167 5008-2013	Slovakia		PRODUCT NAME: KRIZOTINIB; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
1786785	C20130007 00075	Estonia		PRODUCT NAME: KRISOTINIIB;REG NO/DATE: K(2012)7617 LOPLIK 23.10.2012
1786785	92155	Luxembourg		PRODUCT NAME: CRIZOTINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE
1786785	12/2013	Austria		PRODUCT NAME: CRIZOTINIB, BEVORZUGT IN FORM EINES PHARMAZEUTISCH AKZEPTABLEN SALZES, HYDRATS ODER SOLVATS; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023