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Vandetanib - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for vandetanib?

Vandetanib is the generic ingredient in one branded drug marketed by Genzyme Corp and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-one patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for Generic Name: vandetanib

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packagers: see list1
Bulk Api Vendors: see list86
Clinical Trials: see list51
Patent Applications: see list2,394
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:vandetanib at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme Corp
CAPRELSA
vandetanib
TABLET;ORAL022405-001Apr 6, 2011RXYesNo8,067,427► SubscribeY ► Subscribe
Genzyme Corp
CAPRELSA
vandetanib
TABLET;ORAL022405-002Apr 6, 2011RXYesYesRE42353► SubscribeYY ► Subscribe
Genzyme Corp
CAPRELSA
vandetanib
TABLET;ORAL022405-002Apr 6, 2011RXYesYes8,067,427► SubscribeY ► Subscribe
Genzyme Corp
CAPRELSA
vandetanib
TABLET;ORAL022405-002Apr 6, 2011RXYesYes► Subscribe► Subscribe
Genzyme Corp
CAPRELSA
vandetanib
TABLET;ORAL022405-001Apr 6, 2011RXYesNoRE42353► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: vandetanib

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
6,897,210 Quinazoline derivatives and pharmaceutical compositions containing them► Subscribe
6,673,803 Quinazoline derivatives and pharmaceutical compositions containing them► Subscribe
6,414,148 Quinazoline derivatives and pharmaceutical compositions containing them► 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: vandetanib

Country Document Number Estimated Expiration
Denmark0929530► Subscribe
Portugal1753431► Subscribe
Ukraine81732► Subscribe
MexicoPA06013501► Subscribe
Germany69717294► 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: VANDETANIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00543Netherlands► SubscribePRODUCT NAME: VANDETANIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/749/001-002 20120217
C0048France► SubscribePRODUCT NAME: VANDETANIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/749/002 20120217
90028-8Sweden► SubscribePRODUCT NAME: VANDETANIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/11/749/001 20120217
2012015,C1244647Lithuania► SubscribePRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 20120217
2012015Lithuania► SubscribePRODUCT NAME: VANDETANIBUM; REGISTRATION NO/DATE: EU/1/11/749/001, 2012 02 17 EU/1/11/749/002 20120217
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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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