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Last Updated: December 11, 2024

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 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

SponsorPhase
Kyowa Kirin, Inc.Phase 4
Georgetown UniversityPhase 4
Virginia Commonwealth UniversityPhase 2

See all istradefylline clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for istradefylline

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 ⤷  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
>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 ⤷  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

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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