Upgrade for Complete Access See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Merck
Dow
Express Scripts
AstraZeneca
Baxter
Boehringer Ingelheim

Last Updated: December 3, 2021

DrugPatentWatch Database Preview

Febuxostat - Generic Drug Details

➤ Subscribe for complete access

« Back to Dashboard

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

Febuxostat is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Dr Reddys Labs Ltd, Hikma Pharms, Indoco, MSN, Mylan, Sun Pharm, Sunshine, and Takeda Pharms Usa, and is included in nine 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. Seventeen 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
Eisai Co., Ltd.Phase 3
Ningbo No. 1 HospitalPhase 2
National Taiwan University Hospital, Yun-Lin BranchN/A

See all febuxostat clinical trials

Generic filers with tentative approvals for FEBUXOSTAT
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free80MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free80MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free40MGTABLET;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 NDA Submissiondate
ULORIC TABLET;ORAL febuxostat 021856 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
Hikma Pharms FEBUXOSTAT febuxostat TABLET;ORAL 205414-001 Oct 15, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 AB RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sunshine FEBUXOSTAT febuxostat TABLET;ORAL 213069-001 Jun 2, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharm FEBUXOSTAT febuxostat TABLET;ORAL 205467-001 Jul 1, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 AB RX Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Alembic Pharms Ltd FEBUXOSTAT febuxostat TABLET;ORAL 205421-001 Jul 1, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Indoco FEBUXOSTAT febuxostat TABLET;ORAL 210292-002 Dec 30, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for febuxostat

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1020454 19/2010 Austria ⤷  Try it Free PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454 PA2010005 Lithuania ⤷  Try it Free PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
1020454 CR 2010 00015 Denmark ⤷  Try it Free PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421
1488790 C20140037 00152 Estonia ⤷  Try it Free PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
1020454 PA2010005,C1020454 Lithuania ⤷  Try it Free PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004, 0080421
1020454 SPC/GB10/019 United Kingdom ⤷  Try it Free 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.
1020454 10C0022 France ⤷  Try it Free PRODUCT NAME: FEBUXOSTAT; 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

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
McKesson
Dow
Mallinckrodt
Merck

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.