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Febuxostat - Generic Drug Details

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

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.

This ingredient has ninety-one patent family members in thirty-five countries.

There are twenty-one drug master file entries for febuxostat. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: febuxostat

Tradenames:1
Patents:5
Applicants:1
NDAs:1
Drug Master File Entries: see list21
Suppliers / Packagers: see list4
Bulk Api Vendors: see list85
Clinical Trials: see list33
Patent Applications: see list144
Drug Prices:see low prices
DailyMed Link:febuxostat at DailyMed

Pharmacology for Ingredient: febuxostat

Tentative approvals for FEBUXOSTAT

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET;ORAL40MG
► Subscribe► SubscribeTABLET;ORAL80MG
► Subscribe► SubscribeTABLET;ORAL40MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa
ULORIC
febuxostat
TABLET;ORAL021856-002Feb 13, 2009RXYesYes9,107,912► Subscribe ► Subscribe
Takeda Pharms Usa
ULORIC
febuxostat
TABLET;ORAL021856-001Feb 13, 2009RXYesNo5,614,520► SubscribeYY ► Subscribe
Takeda Pharms Usa
ULORIC
febuxostat
TABLET;ORAL021856-002Feb 13, 2009RXYesYes6,225,474► SubscribeY ► Subscribe
Takeda Pharms Usa
ULORIC
febuxostat
TABLET;ORAL021856-002Feb 13, 2009RXYesYes7,361,676► SubscribeY ► Subscribe
Takeda Pharms Usa
ULORIC
febuxostat
TABLET;ORAL021856-001Feb 13, 2009RXYesNo7,361,676► SubscribeY ► Subscribe
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International Patent Family for Ingredient: febuxostat

Country Document Number Estimated Expiration
Poland200710► Subscribe
Canada2474674► Subscribe
South Africa200000737► Subscribe
Japan4084309► Subscribe
Guatemala199900216► 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
/2010Austria► SubscribePRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION 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
0140037 00152Estonia► SubscribePRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
C0022France► SubscribePRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
2010 005, C 1020454Lithuania► SubscribePRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
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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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