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Last Updated: December 2, 2022

Febuxostat - Generic Drug Details


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

Febuxostat is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Alkem Labs Ltd, Dr Reddys, Hikma, Indoco, MSN, Mylan, Prinston Inc, Sun Pharm, Sunshine, and Takeda Pharms Usa, and is included in eleven NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Febuxostat has twenty-eight patent family members in fifteen countries.

There are twenty-six drug master file entries for febuxostat. Nineteen suppliers are listed for this compound. There are five tentative approvals for this compound.

Drug Prices for febuxostat

See drug prices for febuxostat

Recent Clinical Trials for febuxostat

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Chinese University of Hong KongPhase 2
Tanta UniversityPhase 2
University Hospital, RouenPhase 3

See all febuxostat clinical trials

Generic filers with tentative approvals for FEBUXOSTAT
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing80MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing80MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing40MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for febuxostat
Medical Subject Heading (MeSH) Categories for febuxostat
Paragraph IV (Patent) Challenges for FEBUXOSTAT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ULORIC Tablets febuxostat 40 mg and 80 mg 021856 10 2013-02-13

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
Msn FEBUXOSTAT febuxostat TABLET;ORAL 210461-002 Dec 30, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Prinston Inc FEBUXOSTAT febuxostat TABLET;ORAL 206266-001 Mar 28, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan FEBUXOSTAT febuxostat TABLET;ORAL 205385-002 Jul 1, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alkem Labs Ltd FEBUXOSTAT febuxostat TABLET;ORAL 212924-002 Dec 7, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Indoco FEBUXOSTAT febuxostat TABLET;ORAL 210292-001 Dec 30, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for febuxostat

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for febuxostat

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Krka, d.d., Novo mesto Febuxostat Krka febuxostat EMEA/H/C/004773
Febuxostat Krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Febuxostat Krka is indicated in adults.
Authorised yes no no 2019-03-28
Mylan Pharmaceuticals Limited Febuxostat Mylan febuxostat EMEA/H/C/004374
Febuxostat Mylan is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).Febuxostat Mylan is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Febuxostat Mylan is indicated in adults.
Authorised yes no no 2017-06-15
Menarini International Operations Luxembourg S.A. (MIOL) Adenuric febuxostat EMEA/H/C/000777
80 mg strength:, , , Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis)., Adenuric is indicated in adults., , , 120 mg strength:, , , Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis)., Adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS)., Adenuric is indicated in adults., ,
Authorised no no no 2008-04-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for febuxostat

Country Patent Number Title Estimated Expiration
Japan WO2003082279 単一の結晶形を含有する固形製剤 See Plans and Pricing
Japan 4084309 See Plans and Pricing
Brazil 112013005792 método para o tratamento concomitante de teofilina e febuxostat See Plans and Pricing
Denmark 1488790 See Plans and Pricing
China 103298466 Methods for concomitant treatment of theophylline and febuxostat See Plans and Pricing
Japan 2013539747 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for febuxostat

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1020454 SPC/GB10/019 United Kingdom See Plans and Pricing 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.
1488790 C20140037 00152 Estonia See Plans and Pricing PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
1020454 PA2010005,C1020454 Lithuania See Plans and Pricing PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004, 0080421
1020454 CR 2010 00015 Denmark See Plans and Pricing PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421
1020454 10C0022 France See Plans and Pricing PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454 C300447 Netherlands See Plans and Pricing PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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