Cytarabine; daunorubicin - Generic Drug Details

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

Cytarabine; daunorubicin is the generic ingredient in one branded drug marketed by Celator Pharms and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cytarabine; daunorubicin has one hundred and forty-five patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for cytarabine; daunorubicin

International Patents:	145
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	280
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cytarabine; daunorubicin
DailyMed Link:	cytarabine; daunorubicin at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cytarabine; daunorubicin

Generic Entry Date for cytarabine; daunorubicin^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER Dosage: POWDER;INTRAVENOUS

^*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 cytarabine; daunorubicin

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

Sponsor	Phase
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	Phase 3
Uwe Platzbecker	Phase 2
Gilead Sciences	Phase 2

See all cytarabine; daunorubicin clinical trials

Pharmacology for cytarabine; daunorubicin

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

Anatomical Therapeutic Chemical (ATC) Classes for cytarabine; daunorubicin

US Patents and Regulatory Information for cytarabine; daunorubicin

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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
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Celator Pharms	VYXEOS	cytarabine; daunorubicin	POWDER;INTRAVENOUS	209401-001	Aug 3, 2017		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

EU/EMA Drug Approvals for cytarabine; daunorubicin

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Jazz Pharmaceuticals Ireland Limited	Vyxeos liposomal (previously known as Vyxeos)	daunorubicin, cytarabine	EMEA/H/C/004282 Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).	Authorised	no	no	yes	2018-08-23
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for cytarabine; daunorubicin

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Country	Patent Number	Title	Estimated Expiration
Australia	2002340670		⤷ Sign Up
Spain	2290333		⤷ Sign Up
China	101657098	Fixed drug ratios for treatment of hematopoietic cancers and proliferative disorders	⤷ Sign Up
Hungary	S2200032		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for cytarabine; daunorubicin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2768484	CR 2019 00051	Denmark	⤷ Sign Up	PRODUCT NAME: KOMBINATION AF DAUNORUBICIN OG CYTARABIN; REG. NO/DATE: EU/1/18/1308 20180827
3300601	122022000044	Germany	⤷ Sign Up	PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 20180823
3300601	LUC00271	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827
3300601	2022C/528	Belgium	⤷ Sign Up	PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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