Febuxostat - Generic Drug Details

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, Alkem Labs Ltd, Dr Reddys, Hikma, Indoco, MSN, Mylan, Prinston Inc, Sun Pharm, Sunshine, and Takeda Pharms Usa, and is included in eleven 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. Nineteen suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for febuxostat

International Patents:	28
US Patents:	3
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	86
Patent Applications:	1,946
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for febuxostat
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for febuxostat
What excipients (inactive ingredients) are in febuxostat?	febuxostat excipients list
DailyMed Link:	febuxostat at DailyMed

See drug prices for febuxostat

Recent Clinical Trials for febuxostat

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

Sponsor	Phase
Chinese University of Hong Kong	Phase 2
Tanta University	Phase 2
University Hospital, Rouen	Phase 3

See all febuxostat clinical trials

Generic filers with tentative approvals for FEBUXOSTAT

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET;ORAL
		80MG	TABLET;ORAL
		40MG	TABLET;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

Drug Class	Xanthine Oxidase Inhibitor
Mechanism of Action	Xanthine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for febuxostat

Gout Suppressants

Paragraph IV (Patent) Challenges for FEBUXOSTAT

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 febuxostat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msn	FEBUXOSTAT	febuxostat	TABLET;ORAL	210461-002	Dec 30, 2019	AB	RX	No	No
Prinston Inc	FEBUXOSTAT	febuxostat	TABLET;ORAL	206266-001	Mar 28, 2022	AB	RX	No	No
Mylan	FEBUXOSTAT	febuxostat	TABLET;ORAL	205385-002	Jul 1, 2019	AB	RX	No	No
Alkem Labs Ltd	FEBUXOSTAT	febuxostat	TABLET;ORAL	212924-002	Dec 7, 2021	AB	RX	No	No
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	AB	RX	Yes	No			Y
Indoco	FEBUXOSTAT	febuxostat	TABLET;ORAL	210292-001	Dec 30, 2019	AB	RX	No	No

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
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 febuxostat

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 febuxostat

Country	Patent Number	Title	Estimated Expiration
Japan	WO2003082279	単一の結晶形を含有する固形製剤
Japan	4084309
Brazil	112013005792	método para o tratamento concomitante de teofilina e febuxostat
Denmark	1488790
China	103298466	Methods for concomitant treatment of theophylline and febuxostat
Japan	2013539747

Supplementary Protection Certificates for febuxostat

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.
1488790	C20140037 00152	Estonia		PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
1020454	PA2010005,C1020454	Lithuania		PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004, 0080421
1020454	CR 2010 00015	Denmark		PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421
1020454	10C0022	France		PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454	C300447	Netherlands		PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421