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Last Updated: August 19, 2022

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 patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for cytarabine; daunorubicin
Recent Clinical Trials for cytarabine; daunorubicin

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

SponsorPhase
Institute of Hematology & Blood Diseases HospitalPhase 2/Phase 3
Ioannis MantzarisPhase 1
Sunshine Lake Pharma Co., Ltd.Phase 1/Phase 2

See all cytarabine; daunorubicin clinical trials

US Patents and Regulatory Information for cytarabine; daunorubicin

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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

Country Patent Number Title Estimated Expiration
Japan 2006523713 See Plans and Pricing
Japan 4822666 See Plans and Pricing
Poland 3300601 See Plans and Pricing
Portugal 1432402 See Plans and Pricing
European Patent Office 1615621 COMPOSITIONS D'ADMINISTRATION DE COMBINAISONS DE MEDICAMENTS (COMPOSITIONS FOR DELIVERY OF DRUG COMBINATIONS) See Plans and Pricing
Australia 2002331481 See Plans and Pricing
Canada 2462369 COMPOSITIONS POUR L'ADMINISTRATION DE COMBINAISONS MEDICINALES (COMPOSITIONS FOR DELIVERY OF DRUG COMBINATIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cytarabine; daunorubicin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2768484 384 1-2020 Slovakia See Plans and Pricing PRODUCT NAME: KOMBINACIA DAUNORUBICINU A CYTARABINU; REGISTRATION NO/DATE: EU/1/18/1308 20180827
2768484 CR 2019 00051 Denmark See Plans and Pricing PRODUCT NAME: KOMBINATION AF DAUNORUBICIN OG CYTARABIN; REG. NO/DATE: EU/1/18/1308 20180827
2768484 132019000000144 Italy See Plans and Pricing PRODUCT NAME: DAUNORUBICINA E CITARABINA(VYXEOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1308, 20180827
2768484 C20190039 00312 Estonia See Plans and Pricing PRODUCT NAME: DAUNORUBITSIIN/TSUETARABIIN;REG NO/DATE: EU/1/18/1308 27.08.2018
1744764 SPC/GB18/045 United Kingdom See Plans and Pricing PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTERED: UK EU/1/18/1308/001-003 20180827; UK PLGB 31626/0004 20180827
2768484 LUC00135 Luxembourg See Plans and Pricing PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827
1744764 300960 Netherlands See Plans and Pricing PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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