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Last Updated: March 28, 2024

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-two patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for CYTARABINE; DAUNORUBICIN
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CYTARABINE; DAUNORUBICIN
Generic Entry Date for CYTARABINE; DAUNORUBICIN*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER
Dosage:
POWDER;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CYTARABINE; DAUNORUBICIN

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

SponsorPhase
Uwe PlatzbeckerPhase 2
Gilead SciencesPhase 2
Kura Oncology, Inc.Phase 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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

Supplementary Protection Certificates for CYTARABINE; DAUNORUBICIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3300601 27/2022 Austria ⤷  Try a Trial PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827
1744764 C01744764/01 Switzerland ⤷  Try a Trial PRODUCT NAME: DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68014 17.02.2022
3300601 LUC00271 Luxembourg ⤷  Try a 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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