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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
QuintilesIMS
Mallinckrodt
US Army
US Department of Justice
McKesson
Healthtrust
Chinese Patent Office
Teva
Covington

Generated: November 24, 2017

DrugPatentWatch Database Preview

XALKORI Drug Profile

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What is the patent landscape for Xalkori, 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-five patent family members in forty-seven countries and twelve supplementary protection certificates in eleven countries.

The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.
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;ORAL202570-001Aug 26, 2011RXYesNo► Subscribe► Subscribe ► Subscribe
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-002Aug 26, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-001Aug 26, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-001Aug 26, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-002Aug 26, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-001Aug 26, 2011RXYesNo► Subscribe► Subscribe► Subscribe
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-002Aug 26, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-002Aug 26, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-001Aug 26, 2011RXYesNo► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-001Aug 26, 2011RXYesNo► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: 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
8,106,197Aminoheteroaryl compounds as protein kinase inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: XALKORI

Country Document Number Estimated Expiration
Argentina057964► Subscribe
Mexico2007002312► Subscribe
South Korea20080074950► Subscribe
Israel170291► Subscribe
Argentina056832► Subscribe
Georgia, Republic ofP20084341► Subscribe
BrazilPI0407827► Subscribe
Luxembourg92155► Subscribe
Germany602005020465► Subscribe
Uruguay29081► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: XALKORI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0015France► SubscribePRODUCT NAME: CRIZOTINIB ET SES SELS, HYDRATES ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/793/001 20121023
7 5008-2013Slovakia► SubscribePRODUCT NAME: KRIZOTINIB; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
1786785/01Switzerland► SubscribePRODUCT NAME: CRIZOTINIB; REGISTRATION NO/DATE: SWISSMEDIC 62131 05.03.2012
155Luxembourg► SubscribePRODUCT NAME: CRIZOTINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE
0130007 00075Estonia► SubscribePRODUCT NAME: KRISOTINIIB;REG NO/DATE: K(2012)7617 LOPLIK 23.10.2012
9Finland► Subscribe
2013005,C1786785Lithuania► SubscribePRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004, 0121023
13/009Ireland► SubscribePRODUCT 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
2013 00009Denmark► Subscribe
90008-9Sweden► SubscribePRODUCT NAME: CRIZOTINIB INKLUSIVE ETT FARMACEUTISKT GODTAGBART SALT, SOLVAT ELLER HYDRAT DAERAV; REG. NO/DATE: EU/1/12/793/001 20121023
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Accenture
Boehringer Ingelheim
Moodys
UBS
Covington
Cipla
Queensland Health
Merck
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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