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Last Updated: December 15, 2019

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CYTARABINE; DAUNORUBICIN - Generic Drug Details

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What are the generic sources for cytarabine; daunorubicin and what is the scope of patent protection?

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

Cytarabine; daunorubicin has one hundred and thirteen patent family members in twenty-one countries.

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

Summary for CYTARABINE; DAUNORUBICIN
International Patents:113
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 15
Suppliers / Packagers: 1
Clinical Trials: 238
DailyMed Link:CYTARABINE; DAUNORUBICIN at DailyMed
Recent Clinical Trials for CYTARABINE; DAUNORUBICIN

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

SponsorPhase
University Hospital HeidelbergPhase 3
M.D. Anderson Cancer CenterPhase 1/Phase 2
Ohio State University Comprehensive Cancer CenterPhase 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   Start Trial   Start Trial Y   Start Trial
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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
1744764 122018000134 Germany   Start Trial PRODUCT NAME: ZUSAMMENSETZUNG AUS KOMPONENTE 1 DAUNORUBICIN MIT KOMPONENTE 2 CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 20180823
1744764 18C1047 France   Start Trial PRODUCT NAME: DAUNORUBICINE + CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
1744764 2018C/045 Belgium   Start Trial PRODUCT NAME: VYXEOS (DAUNORUBICINE/CYTARABINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180823
1744764 C201830057 Spain   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Express Scripts

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