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Last Updated: July 15, 2020

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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, Hikma, Indoco Remedies, MSN, Mylan, Sun Pharm, Sunshine Lake, and Takeda Pharms Usa, and is included in eight 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. Thirteen 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
Ai PengN/A
Jiangsu HengRui Medicine Co., Ltd.Phase 2
Arthrosi TherapeuticsPhase 2

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 Trial80MGTABLET;ORAL
  Start Trial  Start 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 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
Indoco Remedies FEBUXOSTAT febuxostat TABLET;ORAL 210292-001 Dec 30, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm FEBUXOSTAT febuxostat TABLET;ORAL 205467-001 Jul 1, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Msn FEBUXOSTAT febuxostat TABLET;ORAL 210461-002 Dec 30, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan FEBUXOSTAT febuxostat TABLET;ORAL 205385-002 Jul 1, 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 021856-001 Feb 13, 2009   Start Trial   Start Trial
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 19/2010 Austria   Start Trial PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454 CR 2010 00015 Denmark   Start Trial PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421
1020454 10C0022 France   Start Trial PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454 PA2010005 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Express Scripts
Merck
AstraZeneca
Dow

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