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XALKORI Drug Profile

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

This drug has one hundred and twenty-one patent family members in forty-six 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 Tradename: XALKORI

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-001Aug 26, 2011RXNo7,825,137► subscribe ► subscribe
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-002Aug 26, 2011RXYes► subscribe► subscribe
Pf Prism Cv
XALKORI
crizotinib
CAPSULE;ORAL202570-001Aug 26, 2011RXNo► subscribe► 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
Iceland2910► subscribe
Japan4695588► subscribe
South Korea20080072965► 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
00587Netherlands► subscribePRODUCT NAME: CRIZOTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/12/793/001-004 20121023
155Luxembourg► subscribePRODUCT NAME: CRIZOTINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE
1786785/01Switzerland► subscribePRODUCT NAME: CRIZOTINIB; REGISTRATION NO/DATE: SWISSMEDIC 62131 05.03.2012
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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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