ULORIC Drug Patent Profile

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.

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
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

See drug prices for ULORIC

See drug sales revenues for ULORIC

Recent Clinical Trials for ULORIC

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

Sponsor	Phase
Ai Peng	N/A
Contract Research Organization: USA	Phase 2
PAREXEL Early Phase Clinical Unit-Los Angeles	Phase 2

See all ULORIC clinical trials

Pharmacology for ULORIC

Drug Class	Xanthine Oxidase Inhibitor
Mechanism of Action	Xanthine Oxidase Inhibitors

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

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

Expired US Patents for ULORIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009

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

International Patents for ULORIC

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9209279
Portugal	1956015
Australia	2003220909	SOLID PREPARATION CONTAINING SINGLE CRYSTAL FORM
Canada	2566652	MODIFICATIONS PERMETTANT DE SYNTHETISER DES POLYMORPHES DE L'ACIDE 2-(3-CYANO-4-ISOBUTYLOXYPHENYL)-4-METHYL-5-THIAZOLE-CARBOXYLIQUE ET METHODES DE PREPARATION CONNEXES (POLYMORPHIC MODIFICATIONS OF 2-(3-CYANO-4-ISOBUTYLOXYPHENYL)-4-METHYL-5-THIAZOLE-CARBOXYLIC ACID AND PROCESSES FOR THE PREPARATION THEREOF)
Hungary	0004325
Indonesia	25775

Supplementary Protection Certificates for ULORIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020454	SPC/GB10/019	United Kingdom		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		PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
1020454	19/2010	Austria		PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454	SPC015/2010	Ireland		SPC015/2010: 20101001, EXPIRES: 20230420
1488790	C20140037 00152	Estonia		PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
1020454	PA 2010 005, C 1020454	Lithuania		PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421