CEDAZURIDINE; DECITABINE - Generic Drug Details

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 fifty-one patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for CEDAZURIDINE; DECITABINE

International Patents:	51
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

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
Otsuka Australia Pharmaceutical Pty Ltd	Phase 3
Taiho Oncology, Inc.	Phase 2
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

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

International Patents for CEDAZURIDINE; DECITABINE

Country	Patent Number	Title	Estimated Expiration
Nicaragua	201000055	2' - FLUORO - 2' - DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA.
Ecuador	SP10010095	2'-FLUORO-2'-DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Costa Rica	11427	2-FLUORO-2 - DESOXITETRAHIDROURIDINAS COMO INHIBIDORES DE CITIDINA DESAMINASA
Slovenia	2207786
Japan	5496899
Brazil	PI0818672	2'-fluor-2'-desoxitetra-hidrouridinas como inibidores da citidina desaminase
Hungary	S2300044

Supplementary Protection Certificates for CEDAZURIDINE; DECITABINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	122023000069	Germany		PRODUCT NAME: ZUSAMMENSETZUNG UMFASSEND: CEDAZURIDIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; UND DECITABIN; REGISTRATION NO/DATE: EU/1/23/1756 20230915
2207786	LUC00326	Luxembourg		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	CA 2023 00038	Denmark		PRODUCT NAME: SAMMENSAETNING OMFATTENDE CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; OG DECITABIN; REG. NO/DATE: EU/1/23/1756 20230918
2207786	2023C/551	Belgium		PRODUCT NAME: UNE COMPOSITION COMPRENANT : DE LA CEDAZURIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ; ET LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
2207786	LUC00327	Luxembourg		PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
2207786	PA2023539	Lithuania		PRODUCT NAME: KOMPOZICIJA, APIMANTI: CEDAZURIDINA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; IR DECITABINAS; REGISTRATION NO/DATE: EU/1/23/1756 20230915
2207786	CR 2023 00037	Denmark		PRODUCT NAME: CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1756 20230918