Details for New Drug Application (NDA): 021856

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NDA 021856 describes ULORIC, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ULORIC profile page.

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.

Summary for 021856

Tradename:	ULORIC
Applicant:	Takeda Pharms Usa
Ingredient:	febuxostat
Patents:	3

Pharmacology for NDA: 021856

Mechanism of Action	Xanthine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for 021856

Gout Suppressants

Suppliers and Packaging for NDA: 021856

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ULORIC	febuxostat	TABLET;ORAL	021856	NDA	Takeda Pharmaceuticals America, Inc.	64764-677	64764-677-11	10 BLISTER PACK in 1 CARTON (64764-677-11) / 10 TABLET in 1 BLISTER PACK
ULORIC	febuxostat	TABLET;ORAL	021856	NDA	Takeda Pharmaceuticals America, Inc.	64764-677	64764-677-13	100 TABLET in 1 BOTTLE (64764-677-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Feb 13, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 8, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Sep 8, 2031	Product Flag?		Substance Flag?		Delist Request?
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
Patent:	⤷ Sign Up	Patent Expiration:	Sep 8, 2031	Product Flag?		Substance Flag?		Delist Request?
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

Expired US Patents for NDA 021856

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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	021856-001	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	021856-002	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

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