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Last Updated: August 19, 2022

ULORIC Drug Patent Profile


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Which patents cover Uloric, and what generic alternatives are available?

Uloric is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in fifteen countries.

The generic ingredient in ULORIC is febuxostat. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the febuxostat profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Uloric

A generic version of ULORIC was approved as febuxostat by ALEMBIC PHARMS LTD on July 1st, 2019.

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Drug patent expirations by year for ULORIC
Drug Prices for ULORIC

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Drug Sales Revenue Trends for ULORIC

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Recent Clinical Trials for ULORIC

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SponsorPhase
Ai PengN/A
Covance Bioanalytical Services, LLCPhase 2
Analytical Laboratory (Pharmacokinetic Sample Analysis): USAPhase 2

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Pharmacology for ULORIC
Paragraph IV (Patent) Challenges for ULORIC
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 ULORIC

ULORIC is protected by three US patents.

Patents protecting ULORIC

Solid preparation containing single crystal form
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for concomitant treatment of theophylline and febuxostat
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE

Methods for concomitant treatment of theophylline and febuxostat
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 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 ULORIC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 021856-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ULORIC

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

Supplementary Protection Certificates for ULORIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1020454 385 Finland See Plans and Pricing
1488790 C20140037 00152 Estonia See Plans and Pricing PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
1020454 19/2010 Austria See Plans and Pricing 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

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