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, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Indoco, Lupin Ltd, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sun Pharm, Sunshine, Torrent, Zydus Lifesciences, and Takeda Pharms Usa, and is included in sixteen 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. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for FEBUXOSTAT

International Patents:	28
US Patents:	3
Tradenames:	2
Applicants:	16
NDAs:	16
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	88
Patent Applications:	1,309
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
Jiangsu HengRui Medicine Co., Ltd.	Phase 3
JW Pharmaceutical	Phase 3
Chinese University of Hong Kong	Phase 2

See all FEBUXOSTAT clinical trials

Generic filers with tentative approvals for FEBUXOSTAT

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

Anatomical Therapeutic Chemical (ATC) Classes for FEBUXOSTAT

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

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

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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
Sun Pharm	FEBUXOSTAT	febuxostat	TABLET;ORAL	205467-002	Jul 1, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	FEBUXOSTAT	febuxostat	TABLET;ORAL	205406-001	Jan 17, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	FEBUXOSTAT	febuxostat	TABLET;ORAL	205406-002	Jan 17, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	FEBUXOSTAT	febuxostat	TABLET;ORAL	205374-001	Oct 22, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Msn	FEBUXOSTAT	febuxostat	TABLET;ORAL	210461-001	Dec 30, 2019	BX	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

EU/EMA Drug Approvals for FEBUXOSTAT

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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 FEBUXOSTAT

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2013109380	СПОСОБ СОПУТСТВУЮЩЕЙ ТЕРАПИИ С ПРИМЕНЕНИЕМ ТЕОФИЛЛИНА И ФЕБУКСОСТАТА	⤷ Sign Up
Spain	2505690		⤷ Sign Up
Japan	4084309		⤷ Sign Up
China	1642546	Solid preparation containing single crystal form	⤷ Sign Up
South Korea	20130097775	METHODS FOR CONCOMITANT TREATMENT OF THEOPHYLLINE AND FEBUXOSTAT	⤷ Sign Up
South Korea	20040101284		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FEBUXOSTAT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020454	PA 2010 005, C 1020454	Lithuania	⤷ Sign Up	PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
1020454	PA2010005	Lithuania	⤷ Sign Up	PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
1020454	19/2010	Austria	⤷ Sign Up	PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454	SPC/GB10/019	United Kingdom	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
1020454	PA2010005,C1020454	Lithuania	⤷ Sign Up	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

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