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Last Updated: April 4, 2020

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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 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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for CYTARABINE; DAUNORUBICIN
Recent Clinical Trials for CYTARABINE; DAUNORUBICIN

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SponsorPhase
Groupe Francophone des MyelodysplasiesPhase 1/Phase 2
Roswell Park Cancer InstitutePhase 2
University Hospital HeidelbergPhase 3

See all CYTARABINE; DAUNORUBICIN clinical trials

Recent Litigation for CYTARABINE; DAUNORUBICIN

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PTAB Litigation
PetitionerDate
2012-10-09

See all CYTARABINE; DAUNORUBICIN litigation

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   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 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 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
>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 46/2018 Austria   Start Trial PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827
1744764 2018/042 Ireland   Start Trial PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180823
1744764 300960 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
2768484 132019000000144 Italy   Start Trial PRODUCT NAME: DAUNORUBICINA E CITARABINA(VYXEOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1308, 20180827
2768484 CA 2019 00051 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF DAUNORUBICIN OG CYTARABIN; REG. NO/DATE: EU/1/18/1308 20180827
2768484 LUC00135 Luxembourg   Start Trial PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND 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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Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Mallinckrodt
Dow
Harvard Business School
McKesson

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