ISTRADEFYLLINE - Generic Drug Details

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What are the generic drug sources for istradefylline and what is the scope of patent protection?

Istradefylline is the generic ingredient in one branded drug marketed by Kyowa Kirin and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Istradefylline has sixty-three patent family members in eighteen countries.

There is one drug master file entry for istradefylline. One supplier is listed for this compound.

Summary for ISTRADEFYLLINE

International Patents:	63
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	25
Patent Applications:	894
What excipients (inactive ingredients) are in ISTRADEFYLLINE?	ISTRADEFYLLINE excipients list
DailyMed Link:	ISTRADEFYLLINE at DailyMed

Recent Clinical Trials for ISTRADEFYLLINE

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

See all ISTRADEFYLLINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ISTRADEFYLLINE

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

US Patents and Regulatory Information for ISTRADEFYLLINE

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-001	Aug 27, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
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	022075-001	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
>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 ISTRADEFYLLINE

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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
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 ISTRADEFYLLINE

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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 ISTRADEFYLLINE

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Country	Patent Number	Title	Estimated Expiration
South Korea	101135917		⤷ Sign Up
Spain	2384685		⤷ 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
Japan	WO2005030219	ジアリールビニレン化合物の安定化方法	⤷ Sign Up
Japan	2012140461	THERAPEUTIC AGENT FOR DYSKINESIS	⤷ Sign Up
>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.