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Last Updated: March 3, 2024

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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 four 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:4
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
Drug Prices for NOURIANZ

See drug prices for NOURIANZ

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NOURIANZ
Generic Entry Date for NOURIANZ*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Georgetown UniversityPhase 4
Kyowa Kirin, Inc.Phase 4
University of FloridaPhase 1/Phase 2

See all NOURIANZ clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for NOURIANZ

US Patents and Regulatory Information for NOURIANZ

NOURIANZ is protected by four 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

Methods of treating patients suffering from movement disorders
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

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 ⤷  Try a Trial
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 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 022075-001 Aug 27, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for NOURIANZ

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.

Country Patent Number Title Estimated Expiration
Japan 4413866 ⤷  Try a Trial
China 100395245 ⤷  Try a Trial
South Korea 20100056569 ⤷  Try a Trial
Brazil 0306919 ⤷  Try a Trial
Taiwan 200517394 Method for stabilization of diarylvinylene compounds ⤷  Try a Trial
Argentina 046169 METODO PARA LA ESTABILIZACION DE COMPUESTOS DE DIARILVINILENO ⤷  Try a Trial
Japan 2010195836 MICROCRYSTAL ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.