Details for New Drug Application (NDA): 022075

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NDA 022075 describes NOURIANZ, which is a drug marketed by Kyowa Kirin and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the NOURIANZ profile page.

The generic ingredient in NOURIANZ is istradefylline. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the istradefylline profile page.

Summary for 022075

Tradename:	NOURIANZ
Applicant:	Kyowa Kirin
Ingredient:	istradefylline
Patents:	3

Suppliers and Packaging for NDA: 022075

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NOURIANZ	istradefylline	TABLET;ORAL	022075	NDA	Kyowa Kirin, Inc.	42747-602	42747-602-07	1 BLISTER PACK in 1 BOX (42747-602-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK
NOURIANZ	istradefylline	TABLET;ORAL	022075	NDA	Kyowa Kirin, Inc.	42747-602	42747-602-90	90 TABLET, FILM COATED in 1 BOTTLE (42747-602-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Aug 27, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 27, 2024
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	⤷ Sign Up	Patent Expiration:	Nov 13, 2024	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jan 28, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	A METHOD OF REDUCING OFF TIME FROM L-DOPA THERAPY, COMPRISING ADMINISTERING, TO A HUMAN PATIENT WITH PARKINSON'S DISEASE, AN EFFECTIVE AMOUNT OF ISTRADEFYLLINE, WHEREIN THE PATIENT CURRENTLY RECEIVES SAID L-DOPA THERAPY

Expired US Patents for NDA 022075

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019	⤷ Sign Up	⤷ Sign Up
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019	⤷ Sign Up	⤷ Sign Up
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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