Istradefylline - Generic Drug Details

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What are the generic drug sources for istradefylline and what is the scope of freedom to operate?

Istradefylline is the generic ingredient in one branded drug marketed by Kyowa Kirin and is included in one NDA. There are four 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:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	24
Patent Applications:	1,103
What excipients (inactive ingredients) are in istradefylline?	istradefylline excipients list
DailyMed Link:	istradefylline at DailyMed

Recent Clinical Trials for istradefylline

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Sponsor	Phase
University of Florida	Phase 1/Phase 2
Randy Trumbower, PT, PhD	Phase 1/Phase 2
ALS Association	Phase 1/Phase 2

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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	022075-002	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	022075-001	Aug 27, 2019		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y	Y		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

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	See Plans and Pricing	See Plans and Pricing
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019	See Plans and Pricing	See Plans and Pricing
Kyowa Kirin	NOURIANZ	istradefylline	TABLET;ORAL	022075-002	Aug 27, 2019	See Plans and Pricing	See Plans and Pricing
>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
European Patent Office	2044940		See Plans and Pricing
European Patent Office	1469855		See Plans and Pricing
Portugal	2942082		See Plans and Pricing
>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.