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Last Updated: May 6, 2021

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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 twenty-eight patent family members in twenty-five countries.

There are fifteen drug master file entries for cytarabine; daunorubicin. One supplier is listed for this compound.

Recent Clinical Trials for cytarabine; daunorubicin

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

SponsorPhase
AbbViePhase 2
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyPhase 3
Incyte CorporationPhase 1

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   Get Started for $10   Get Started for $10   Get Started for $10
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for cytarabine; daunorubicin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2768484 LUC00135 Luxembourg   Get Started for $10 PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827
2768484 132019000000144 Italy   Get Started for $10 PRODUCT NAME: DAUNORUBICINA E CITARABINA(VYXEOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1308, 20180827
1744764 C201830057 Spain   Get Started for $10 PRODUCT NAME: DAUNORUBICINA + CITARABINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1308; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1308; DATE OF FIRST AUTHORISATION IN EEA: 20180823
2768484 1990053-9 Sweden   Get Started for $10 PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REG. NO/DATE: EU/1/18/1308 20180827
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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