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Serving leading biopharmaceutical companies globally:

Colorcon
Healthtrust
McKinsey
Deloitte
Julphar
Federal Trade Commission
Covington
US Army
Cantor Fitzgerald
Queensland Health

Generated: December 12, 2017

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Febuxostat - Generic Drug Details

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What are the generic sources for febuxostat and what is the scope of febuxostat freedom to operate?

Febuxostat
is the generic ingredient in one branded drug marketed by Takeda Pharms Usa and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Febuxostat has one hundred and three patent family members in thirty-five countries and thirteen supplementary protection certificates in ten countries.

There are twenty-four drug master file entries for febuxostat. Five suppliers are listed for this compound. There are three tentative approvals for this compound.

Pharmacology for febuxostat

Medical Subject Heading (MeSH) Categories for febuxostat

Tentative approvals for FEBUXOSTAT

Applicant Application No. Strength Dosage Form
u► Subscribe40MGTABLET;ORAL
u► Subscribe80MGTABLET;ORAL
u► Subscribe80MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms UsaULORICfebuxostatTABLET;ORAL021856-001Feb 13, 2009RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaULORICfebuxostatTABLET;ORAL021856-001Feb 13, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaULORICfebuxostatTABLET;ORAL021856-002Feb 13, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaULORICfebuxostatTABLET;ORAL021856-001Feb 13, 2009RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaULORICfebuxostatTABLET;ORAL021856-002Feb 13, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaULORICfebuxostatTABLET;ORAL021856-001Feb 13, 2009RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaULORICfebuxostatTABLET;ORAL021856-001Feb 13, 2009RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Takeda Pharms UsaULORICfebuxostatTABLET;ORAL021856-002Feb 13, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaULORICfebuxostatTABLET;ORAL021856-002Feb 13, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Takeda Pharms UsaULORICfebuxostatTABLET;ORAL021856-002Feb 13, 2009RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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International Patent Family for Ingredient: febuxostat

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9965885► Subscribe
Germany122008000051► Subscribe
European Patent Office1488790► Subscribe
China103298466► Subscribe
Australia4289299► Subscribe
South Korea100511183► Subscribe
China1275126► Subscribe
Australia645867► Subscribe
TaiwanI248439► Subscribe
Hong Kong1189170► 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: FEBUXOSTAT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010005,C1020454Lithuania► SubscribePRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004, 0080421
00447Netherlands► SubscribePRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
C0022France► SubscribePRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
2010 00015Denmark► Subscribe
0140037 00152Estonia► SubscribePRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
2010 00015Denmark► SubscribePRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421
2010005Lithuania► SubscribePRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
682Luxembourg► Subscribe91682, EXPIRES: 20230421
/2010Austria► SubscribePRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
C/GB10/019United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB10/019 GRANTED TO TEIJIN LIMITED IN RESPECT OF THE PRODUCT FEBUXOSTAT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6408 DATED 14/03/2012 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22/04/2023.
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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
US Department of Justice
Julphar
Citi
Accenture
Boehringer Ingelheim
McKesson
Fish and Richardson
Daiichi Sankyo

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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