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Last Updated: March 29, 2024

Cedazuridine; decitabine - Generic Drug Details


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

Cedazuridine; decitabine is the generic ingredient in one branded drug marketed by Otsuka and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cedazuridine; decitabine has forty-four patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for cedazuridine; decitabine
International Patents:44
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 36
DailyMed Link:cedazuridine; decitabine at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for cedazuridine; decitabine
Generic Entry Date for cedazuridine; decitabine*:
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 cedazuridine; decitabine

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

SponsorPhase
Otsuka Australia Pharmaceutical Pty LtdPhase 3
Taiho Oncology, Inc.Phase 2
National Comprehensive Cancer NetworkPhase 2

See all cedazuridine; decitabine clinical trials

Pharmacology for cedazuridine; decitabine
Anatomical Therapeutic Chemical (ATC) Classes for cedazuridine; decitabine

US Patents and Regulatory Information for cedazuridine; decitabine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Otsuka INQOVI cedazuridine; decitabine TABLET;ORAL 212576-001 Jul 7, 2020 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

International Patents for cedazuridine; decitabine

Country Patent Number Title Estimated Expiration
Cyprus 1112781 ⤷  Try a Trial
Japan 2014177455 2'-FLUORO-2'-DEOXYTETRAHYDROURIDINE AS CYTIDINE DEAMINASE INHIBITOR ⤷  Try a Trial
European Patent Office 2207786 2'-FLUORO-2'-DÉSOXYTETRAHYDROURIDINES COMME INHIBITEURS DE CYTIDINE DÉSAMINASE (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cedazuridine; decitabine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2207786 301256 Netherlands ⤷  Try a Trial PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918
2207786 CA 2023 00038 Denmark ⤷  Try a Trial PRODUCT NAME: SAMMENSAETNING OMFATTENDE CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; OG DECITABIN; REG. NO/DATE: EU/1/23/1756 20230918
2207786 301257 Netherlands ⤷  Try a Trial PRODUCT NAME: SAMENSTELLING WELKE OMVAT: CEDAZURIDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN DECITABINE; REGISTRATION NO/DATE: EU/1/23/1756 20230918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.