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NOURIANZ Drug Patent Profile

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When do Nourianz patents expire, and what generic alternatives are available?

Nourianz is a drug marketed by Kyowa Kirin and is included in one NDA. There are three patents protecting this drug.

This drug has sixty-three patent family members in eighteen countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Nourianz

Nourianz was eligible for patent challenges on August 27, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 13, 2024. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for NOURIANZ

International Patents:	63
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	3
Patent Applications:	448
Drug Prices:	Drug price information for NOURIANZ
What excipients (inactive ingredients) are in NOURIANZ?	NOURIANZ excipients list
DailyMed Link:	NOURIANZ at DailyMed

Drug patent expirations by year for NOURIANZ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NOURIANZ

Generic Entry Date for NOURIANZ^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 022075 Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for NOURIANZ

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

Sponsor	Phase
Kyowa Kirin, Inc.	Phase 4
Georgetown University	Phase 4
ALS Association	Phase 1/Phase 2

See all NOURIANZ clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NOURIANZ

N04CX	Other antiparkinson drugs
N04C	OTHER ANTIPARKINSON DRUGS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for NOURIANZ

NOURIANZ is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NOURIANZ is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NOURIANZ

Microcrystal
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Administering adenosine A.sub.2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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

Method of stabilizing diarylvinylene compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting NOURIANZ

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

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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
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a 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 NOURIANZ

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

EU/EMA Drug Approvals for NOURIANZ

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	Nouryant	istradefylline	EMEA/H/C/005308 Istradefylline is indicated in adults as an adjunctive treatment to levodopa based regimens in patients with Parkinson’s disease (PD) experiencing “OFF” time.	Refused	no	no	no		2022-01-06
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for NOURIANZ

See the table below for patents covering NOURIANZ around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1469855		⤷ Try a Trial
Japan	4376630		⤷ Try a Trial
Japan	4606326		⤷ Try a Trial
China	101822676		⤷ Try a Trial
Canada	2473864	COMPOSITION DE TRAITEMENT DES PATIENTS SOUFFRANT DE TROUBLES MOTEURS (COMPOSITION FOR USE IN TREATING PATIENTS SUFFERING FROM MOVEMENT DISORDER)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration