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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Fish and Richardson
Harvard Business School
QuintilesIMS
Teva
Cipla
Chubb
McKinsey
Deloitte
US Army

Generated: November 23, 2017

DrugPatentWatch Database Preview

Axitinib - Generic Drug Details

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

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

Axitinib has one hundred and five patent family members in fifty-three countries and twelve supplementary protection certificates in ten countries.

There are four drug master file entries for axitinib. Two suppliers are listed for this compound.

Pharmacology for axitinib

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
INLYTA
axitinib
TABLET;ORAL202324-001Jan 27, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-002Jan 27, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-001Jan 27, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-001Jan 27, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-001Jan 27, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-002Jan 27, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-002Jan 27, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-002Jan 27, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: axitinib

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
6,531,491 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use► Subscribe
7,141,587Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use► Subscribe
6,891,044 Indazole compounds and pharmaceutical compositions for Inhibiting protein kinases, and methods for their use► Subscribe
6,884,890 Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use► 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: axitinib

Country Document Number Estimated Expiration
Argentina035554► Subscribe
Uruguay26231► Subscribe
Brazil0012352► Subscribe
Russian Federation2009136593► Subscribe
Taiwan200911781► Subscribe
Poland212108► Subscribe
Georgia, Republic ofP20063885► Subscribe
Hungary0202490► Subscribe
Costa Rica6517► Subscribe
BrazilPI0012352► 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: AXITINIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
8Finland► Subscribe
154Luxembourg► SubscribePRODUCT NAME: AXITINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE
1218348/01Switzerland► SubscribePRODUCT NAME: AXITINIB; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62281 20120410
C0010France► SubscribePRODUCT NAME: AXITINIB, ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/777/001 20120903
2013003Lithuania► SubscribePRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
2013000016Germany► SubscribePRODUCT NAME: AXITINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
2013 00010Denmark► SubscribePRODUCT NAME: AXITINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/12/777/001-006 20120903
2013 00010Denmark► Subscribe
00576Netherlands► SubscribePRODUCT NAME: AXITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
90007-1Sweden► SubscribePRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 20120903
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Teva
Farmers Insurance
Accenture
Fish and Richardson
Cipla
Covington
Mallinckrodt
Citi
Novartis
Medtronic

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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