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 Pharms Ltd, Dr Reddys Labs Ltd, Hikma, Indoco, MSN, Mylan, Sun Pharm, Sunshine, and Takeda Pharms Usa, and is included in nine 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. Seventeen 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:	9
NDAs:	9
Drug Master File Entries:	26
Suppliers / Packagers:	17
Bulk Api Vendors:	123
Clinical Trials:	72
Patent Applications:	1,533
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

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Sponsor	Phase
National Taiwan University Hospital, Yun-Lin Branch	N/A
National Taiwan University Hospital	N/A
Ai Peng	N/A

See all febuxostat clinical trials

Generic filers with tentative approvals for FEBUXOSTAT

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

Paragraph IV (Patent) Challenges for FEBUXOSTAT

Tradename	Dosage	Ingredient	NDA	Submissiondate
ULORIC	TABLET;ORAL	febuxostat	021856	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
Mylan	FEBUXOSTAT	febuxostat	TABLET;ORAL	205385-001	Jul 1, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Hikma	FEBUXOSTAT	febuxostat	TABLET;ORAL	205414-002	Oct 15, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Hikma	FEBUXOSTAT	febuxostat	TABLET;ORAL	205414-001	Oct 15, 2019	AB	RX	No	No	Start Trial	Start Trial				Start 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 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	Start Trial	Start Trial
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	Start Trial	Start Trial
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for febuxostat

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2012033941	Start Trial
Japan	2013539747	Start Trial
European Patent Office	2613780	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for febuxostat

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020454	10C0022	France	Start Trial	PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454	19/2010	Austria	Start Trial	PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454	PA 2010 005, C 1020454	Lithuania	Start Trial	PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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