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Last Updated: August 14, 2022

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 will be eligible for patent challenges on August 27, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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: 81
Clinical Trials: 2
Patent Applications: 530
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 Generic Entry Opportunity 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
University of FloridaPhase 1/Phase 2
ALS AssociationPhase 1/Phase 2
Randy Trumbower, PT, PhDPhase 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Administering adenosine A.sub.2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting NOURIANZ

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kyowa Kirin NOURIANZ istradefylline TABLET;ORAL 022075-002 Aug 27, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kyowa Kirin NOURIANZ istradefylline TABLET;ORAL 022075-001 Aug 27, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kyowa Kirin NOURIANZ istradefylline TABLET;ORAL 022075-002 Aug 27, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

When does loss-of-exclusivity occur for NOURIANZ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 04236101
Estimated Expiration: See Plans and Pricing

Austria

Patent: 6450
Estimated Expiration: See Plans and Pricing

Canada

Patent: 25037
Estimated Expiration: See Plans and Pricing

China

Patent: 84405
Estimated Expiration: See Plans and Pricing

Patent: 0395245
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 26049
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2004099207
Estimated Expiration: See Plans and Pricing

Patent: 06326
Estimated Expiration: See Plans and Pricing

Patent: 10195836
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1229594
Estimated Expiration: See Plans and Pricing

Patent: 060015570
Estimated Expiration: See Plans and Pricing

Patent: 110128216
Estimated Expiration: See Plans and Pricing

Spain

Patent: 84685
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
South Korea 20100056569 See Plans and Pricing
European Patent Office 2942082 ANTAGONISTES DES RÉCEPTEURS A2A POUR UTILISATION DANS LE TRAITEMENT DES TROUBLES DU MOUVEMENT (A2A RECEPTOR ANTOGONISTS FOR USE IN THE TREATMENT OF MOVEMENT DISORDERS) See Plans and Pricing
Japan 4413866 See Plans and Pricing
Japan 5171556 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
Boehringer Ingelheim
AstraZeneca
McKinsey
Dow

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.