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Serving leading biopharmaceutical companies globally:

Moodys
Express Scripts
Harvard Business School
Medtronic
Johnson and Johnson
AstraZeneca

Last Updated: March 28, 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 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 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

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

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

Identify potential future generic entrants

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 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
2768484 301016 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN 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 300960 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
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:

Moodys
Express Scripts
Harvard Business School
Medtronic
Johnson and Johnson
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.