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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-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:	75
Clinical Trials:	27
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

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Non-Orange Book US Patents for XALKORI

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
8,106,197	Aminoheteroaryl compounds as protein kinase inhibitors

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International Patents for XALKORI

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004076412
Australia	2004215428
Mexico	PA05009063
Canada	2578066

Supplementary Protection Certificates for XALKORI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
9	Finland
0130007 00075	Estonia		PRODUCT NAME: KRISOTINIIB;REG NO/DATE: K(2012)7617 LOPLIK 23.10.2012
13/009	Ireland		PRODUCT NAME: PRODUCT (I.E. ACTIVE INGREDIENT OR COMBINATION OF ACTIVE INGREDIENTS) FOR WHICH A CERTIFICATE IS REQUESTED: CRIZOTINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/12/793/001 EU/1/12/793/004 20121023
2013005	Lithuania		PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023