You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Febuxostat - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Indoco, Lupin Ltd, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sun Pharm, Sunshine, Torrent, Zydus Lifesciences, and Takeda Pharms Usa, and is included in sixteen 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. Twenty-three suppliers are listed for this compound. There is one tentative approval 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
JW PharmaceuticalPhase 3
Chinese University of Hong KongPhase 2
Tanta UniversityPhase 2

See all febuxostat clinical trials

Generic filers with tentative approvals for FEBUXOSTAT
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial80MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial40MGTABLET;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
Torrent FEBUXOSTAT febuxostat TABLET;ORAL 211837-002 Dec 19, 2023 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma FEBUXOSTAT febuxostat TABLET;ORAL 205414-002 Oct 15, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma FEBUXOSTAT febuxostat TABLET;ORAL 205414-001 Oct 15, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc FEBUXOSTAT febuxostat TABLET;ORAL 206266-001 Mar 28, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys FEBUXOSTAT febuxostat TABLET;ORAL 205374-002 Oct 22, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 021856-001 Feb 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
>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
European Patent Office 1488790 PRÉPARATION SOLIDE CONTENANT UNE FORME DU CRYSTAL A D'UNE ACIDE CARBOXYLIQUE D'UN THIAZOL DÉRIVÉE (SOLID PREPARATION CONTAINING A SINGLE CRYSTAL A FORM OF A THIAZOLECARBOXYLIC ACID DERIVATIVE) ⤷  Try a Trial
Denmark 1488790 ⤷  Try a Trial
Australia 2011299153 Methods for concomitant treatment of theophylline and febuxostat ⤷  Try a Trial
Cyprus 1115490 ⤷  Try a Trial
Canada 2812034 METHODES DE TRAITEMENT SIMULTANE A BASE DE THEOPHYLLINE ET DE FEBUXOSTAT (METHODS FOR CONCOMITANT TREATMENT OF THEOPHYLLINE AND FEBUXOSTAT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for febuxostat

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1488790 C20140037 00152 Estonia ⤷  Try a Trial PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
1020454 CR 2010 00015 Denmark ⤷  Try a Trial PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421
1020454 C300447 Netherlands ⤷  Try a Trial PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454 PA2010005 Lithuania ⤷  Try a Trial PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
1020454 19/2010 Austria ⤷  Try a Trial PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.