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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cedazuridine; decitabine has sixty-two patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for CEDAZURIDINE; DECITABINE

International Patents:	62
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	40
DailyMed Link:	CEDAZURIDINE; DECITABINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CEDAZURIDINE; DECITABINE

Generic Entry Date for CEDAZURIDINE; DECITABINE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Pamela Munster	Phase 1
Otsuka Australia Pharmaceutical Pty Ltd	Phase 3
National Comprehensive Cancer Network	Phase 2

See all CEDAZURIDINE; DECITABINE clinical trials

Pharmacology for CEDAZURIDINE; DECITABINE

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CEDAZURIDINE; DECITABINE

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for CEDAZURIDINE; DECITABINE

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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
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Otsuka	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	⤷ 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

International Patents for CEDAZURIDINE; DECITABINE

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Country	Patent Number	Title	Estimated Expiration
Spain	2616566		⤷ Sign Up
Serbia	52323	2'-FLUORO-2'-DEOKSITETRAHIDROURIDINI KAO INHIBITORI CITIDIN DEAMINAZE (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)	⤷ Sign Up
Colombia	6270330	2-FLUORO-2`-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA	⤷ Sign Up
Slovenia	2207786		⤷ Sign Up
Brazil	112022013264	COMBINAÇÃO DE FORMAS DE DOSAGEM ORAL SÓLIDA DE DECITABINA E CEDAZURIDINA	⤷ Sign Up
European Patent Office	2447272	2'-FLUORO-2'-DEOXYTÉTRAHYDROURIDINES EN TANT QU'INHIBITEURS DE DÉSAMINASE DE LA CYTIDINE (2'-FLUORO-2'-DEOXYTETRAHYDROURIDINES AS CYTIDINE DEAMINASE INHIBITORS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CEDAZURIDINE; DECITABINE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	301257	Netherlands	⤷ Sign Up	PRODUCT NAME: SAMENSTELLING WELKE OMVAT: CEDAZURIDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN DECITABINE; REGISTRATION NO/DATE: EU/1/23/1756 20230918
2207786	LUC00327	Luxembourg	⤷ Sign Up	PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
2207786	CA 2023 00037	Denmark	⤷ Sign Up	PRODUCT NAME: CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1756 20230918
2207786	PA2023538	Lithuania	⤷ Sign Up	PRODUCT NAME: CEDAZURIDINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1756 20230915
2207786	LUC00326	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMPOSITION COMPRENANT: DE LA CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; ET DE LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230913
2207786	122023000069	Germany	⤷ Sign Up	PRODUCT NAME: ZUSAMMENSETZUNG UMFASSEND: CEDAZURIDIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; UND DECITABIN; REGISTRATION NO/DATE: EU/1/23/1756 20230915
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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