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Last Updated: March 8, 2021

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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, Dr Reddys Labs Ltd, Hikma, 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

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Recent Clinical Trials for febuxostat

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

SponsorPhase
National Taiwan University Hospital, Yun-Lin BranchN/A
National Taiwan University HospitalN/A
Ai PengN/A

See all febuxostat clinical trials

Generic filers with tentative approvals for FEBUXOSTAT
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial80MGTABLET;ORAL
  Start Trial  Start Trial40MGTABLET;ORAL
  Start Trial  Start Trial80MGTABLET;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
Mylan FEBUXOSTAT febuxostat TABLET;ORAL 205385-001 Jul 1, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma FEBUXOSTAT febuxostat TABLET;ORAL 205414-002 Oct 15, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma FEBUXOSTAT febuxostat TABLET;ORAL 205414-001 Oct 15, 2019 AB RX No No   Start Trial   Start Trial   Start 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 021856-002 Feb 13, 2009   Start Trial   Start Trial
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009   Start Trial   Start Trial
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009   Start Trial   Start Trial
>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 10C0022 France   Start Trial PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454 19/2010 Austria   Start Trial PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454 PA 2010 005, C 1020454 Lithuania   Start Trial PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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