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Axitinib - Generic Drug Details

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

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

Axitinib has ninety-seven patent family members in fifty-three countries.

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

Summary for Generic Name: axitinib

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: see list4
Suppliers / Packagers: see list2
Bulk Api Vendors: see list80
Clinical Trials: see list47
Patent Applications: see list128
Drug Prices:see low prices
DailyMed Link:axitinib at DailyMed

Pharmacology for Ingredient: axitinib

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-001Jan 27, 2012RXYesNo6,534,524► SubscribeYY ► Subscribe
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-002Jan 27, 2012RXYesYes7,141,581► Subscribe ► Subscribe
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-002Jan 27, 2012RXYesYes6,534,524► SubscribeYY ► Subscribe
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-001Jan 27, 2012RXYesNo7,141,581► Subscribe ► Subscribe
Pf Prism Cv
INLYTA
axitinib
TABLET;ORAL202324-002Jan 27, 2012RXYesYes► 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
6,884,890 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
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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
Portugal1614683► Subscribe
Germany60036879► Subscribe
Norway20015797► Subscribe
World Intellectual Property Organization (WIPO)0102369► Subscribe
Spain2293906► 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
2013003Lithuania► SubscribePRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903
13/008Ireland► SubscribePRODUCT NAME: AXITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/12/777/001 EU/1/12/777/006 20120903
90007-1Sweden► SubscribePRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 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
00576Netherlands► SubscribePRODUCT NAME: AXITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903
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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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