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Last Updated: April 22, 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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for istradefylline
Generic Entry Date for istradefylline*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for istradefylline

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

SponsorPhase
Georgetown UniversityPhase 4
Kyowa Kirin, Inc.Phase 4
Randy Trumbower, PT, PhDPhase 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 022075-001 Aug 27, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Kyowa Kirin NOURIANZ istradefylline TABLET;ORAL 022075-002 Aug 27, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Kyowa Kirin NOURIANZ istradefylline TABLET;ORAL 022075-002 Aug 27, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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.