ULORIC Drug Patent Profile

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When do Uloric patents expire, 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. Twenty-three 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 on July 1^st, 2019.

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Summary for ULORIC

International Patents:	28
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	27
Patent Applications:	629
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ULORIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ULORIC
What excipients (inactive ingredients) are in ULORIC?	ULORIC excipients list
DailyMed Link:	ULORIC at DailyMed

Drug patent expirations by year for ULORIC

Recent Clinical Trials for ULORIC

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

Sponsor	Phase
Ai Peng	N/A
Analytical Laboratory (Pharmacokinetic Sample Analysis): USA	Phase 2
AstraZeneca	Phase 2

See all ULORIC clinical trials

Pharmacology for ULORIC

Drug Class	Xanthine Oxidase Inhibitor
Mechanism of Action	Xanthine Oxidase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ULORIC

M04AA	Preparations inhibiting uric acid production
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Methods for concomitant treatment of theophylline and febuxostat
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ 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 ULORIC

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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	021856-001	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
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	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 ULORIC

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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 ULORIC

See the table below for patents covering ULORIC around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	8952291		⤷ Try a Trial
Hungary	0004325		⤷ Try a Trial
South Africa	200000737	Polymorphs of 2-(3-cyano-4-Isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and method of producing the same.	⤷ Try a Trial
Indonesia	25775		⤷ Try a Trial
Australia	2003220909	SOLID PREPARATION CONTAINING SINGLE CRYSTAL FORM	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ULORIC

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020454	CA 2010 00015	Denmark	⤷ Try a Trial
1020454	385	Finland	⤷ Try a Trial
1020454	SPC/GB10/019	United Kingdom	⤷ Try a Trial	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	PA2010005	Lithuania	⤷ Try a Trial	PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
1020454	PA2010005,C1020454	Lithuania	⤷ Try a Trial	PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004, 0080421
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description