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Last Updated: February 7, 2023

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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of FloridaPhase 1/Phase 2
Randy Trumbower, PT, PhDPhase 1/Phase 2
ALS AssociationPhase 1/Phase 2

See all istradefylline clinical trials

US Patents and Regulatory Information for istradefylline

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

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

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

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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.