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.
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: | 384 |
Drug Prices: | Drug price information for NOURIANZ |
What excipients (inactive ingredients) are in NOURIANZ? | NOURIANZ excipients list |
DailyMed Link: | NOURIANZ at DailyMed |
Recent Clinical Trials for NOURIANZ
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Georgetown University | Phase 4 |
Kyowa Kirin, Inc. | Phase 4 |
ALS Association | Phase 1/Phase 2 |
US Patents and Regulatory Information for NOURIANZ
NOURIANZ is protected by three US patents and one FDA Regulatory Exclusivity.
Patents protecting NOURIANZ
Microcrystal
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Administering adenosine A.sub.2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting NOURIANZ
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-002 | Aug 27, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-001 | Aug 27, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-002 | Aug 27, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-001 | Aug 27, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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
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 |
Kyowa Kirin | NOURIANZ | istradefylline | TABLET;ORAL | 022075-001 | Aug 27, 2019 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
---|---|---|---|
Spain | 2384685 | ⤷ Sign Up | |
Japan | 4413866 | ⤷ Sign Up | |
Japan | 2009067807 | DRUG FOR TREATING DYSKINESIS | ⤷ Sign Up |
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) | ⤷ Sign Up |
Australia | 2004275646 | Method of stabilizing diarylvinylene compound | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |