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Serving leading biopharmaceutical companies globally:

US Army
Fish and Richardson
Cerilliant
Cantor Fitzgerald
Julphar
Farmers Insurance
US Department of Justice
Chubb
Accenture
Deloitte

Generated: December 12, 2017

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Crizotinib - Generic Drug Details

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What are the generic drug sources for crizotinib and what is the scope of crizotinib patent protection?

Crizotinib
is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Crizotinib has one hundred and forty-four patent family members in forty-seven countries and twelve supplementary protection certificates in eleven countries.

One supplier is listed for this compound.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Pf Prism CvXALKORIcrizotinibCAPSULE;ORAL202570-001Aug 26, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Pf Prism CvXALKORIcrizotinibCAPSULE;ORAL202570-001Aug 26, 2011RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Pf Prism CvXALKORIcrizotinibCAPSULE;ORAL202570-001Aug 26, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Pf Prism CvXALKORIcrizotinibCAPSULE;ORAL202570-001Aug 26, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvXALKORIcrizotinibCAPSULE;ORAL202570-002Aug 26, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Pf Prism CvXALKORIcrizotinibCAPSULE;ORAL202570-002Aug 26, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvXALKORIcrizotinibCAPSULE;ORAL202570-002Aug 26, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Pf Prism CvXALKORIcrizotinibCAPSULE;ORAL202570-001Aug 26, 2011RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvXALKORIcrizotinibCAPSULE;ORAL202570-002Aug 26, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Pf Prism CvXALKORIcrizotinibCAPSULE;ORAL202570-002Aug 26, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: crizotinib

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 Ingredient: crizotinib

Country Document Number Estimated Expiration
Australia2005276135► Subscribe
Peru05012006► Subscribe
World Intellectual Property Organization (WIPO)2006021884► Subscribe
Serbia20050708► Subscribe
Mexico2007002312► Subscribe
European Patent Office1786785► Subscribe
African Regional IP Organization (ARIPO)2373► Subscribe
Iceland2910► Subscribe
Costa Rica7961► Subscribe
African Regional IP Organization (ARIPO)2114► 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: CRIZOTINIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2013005,C1786785Lithuania► SubscribePRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004, 0121023
155Luxembourg► SubscribePRODUCT NAME: CRIZOTINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE
9Finland► Subscribe
2013005Lithuania► SubscribePRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023
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
90008-9Sweden► SubscribePRODUCT NAME: CRIZOTINIB INKLUSIVE ETT FARMACEUTISKT GODTAGBART SALT, SOLVAT ELLER HYDRAT DAERAV; REG. NO/DATE: EU/1/12/793/001 20121023
C0015France► SubscribePRODUCT NAME: CRIZOTINIB ET SES SELS, HYDRATES ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/793/001 20121023
1786785/01Switzerland► SubscribePRODUCT NAME: CRIZOTINIB; REGISTRATION NO/DATE: SWISSMEDIC 62131 05.03.2012
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Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Covington
Colorcon
Fish and Richardson
Healthtrust
Cantor Fitzgerald
Harvard Business School
Teva
Johnson and Johnson

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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