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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Queensland Health
Harvard Business School
UBS
Express Scripts
Medtronic
Cipla
Covington
Julphar
Chubb

Generated: February 21, 2018

DrugPatentWatch Database Preview

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 five patent family members in thirty-five countries.

There are twenty-five 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
➤ Sign Up➤ Sign Up40MGTABLET;ORAL
➤ Sign Up➤ Sign Up80MGTABLET;ORAL
➤ Sign Up➤ Sign Up80MGTABLET;ORAL

US Patents and Regulatory Information for febuxostat

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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International Patents for febuxostat

Supplementary Protection Certificates for febuxostat

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
682 Luxembourg ➤ Sign Up 91682, EXPIRES: 20230421
2010 00015 Denmark ➤ Sign Up
2010005,C1020454 Lithuania ➤ Sign Up PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004, 0080421
C/GB10/019 United Kingdom ➤ Sign Up SUPPLEMENTARY 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.
00447 Netherlands ➤ Sign Up PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
C015/2010 Ireland ➤ Sign Up SPC015/2010: 20101001, EXPIRES: 20230420
2010 005, C 1020454 Lithuania ➤ Sign Up PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
C0022 France ➤ Sign Up PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
5 Finland ➤ Sign Up
0140037 00152 Estonia ➤ Sign Up PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
McKinsey
Dow
Farmers Insurance
Federal Trade Commission
US Army
Julphar
Medtronic
McKesson

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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