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Last Updated: October 5, 2024

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VYXEOS Drug Patent Profile


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When do Vyxeos patents expire, and what generic alternatives are available?

Vyxeos is a drug marketed by Celator Pharms and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and forty-five patent family members in twenty-six countries.

The generic ingredient in VYXEOS is cytarabine; daunorubicin. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cytarabine; daunorubicin profile page.

DrugPatentWatch® Generic Entry Outlook for Vyxeos

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for VYXEOS
Drug Prices for VYXEOS

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VYXEOS
Generic Entry Date for VYXEOS*:
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
NDA:
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 VYXEOS

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

SponsorPhase
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Phase 3
Eastern Cooperative Oncology GroupPhase 2
St. Jude Children's Research HospitalPhase 2

See all VYXEOS clinical trials

US Patents and Regulatory Information for VYXEOS

VYXEOS is protected by ten US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYXEOS is ⤷  Sign Up.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VYXEOS

Method of lyophilizing liposomes
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF ADMINISTERING A RECONSTITUTED LIPOSOMAL COMPOSITION CONTAINING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER

Method of lyophilizing liposomes
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF RECONSTITUTING A LYOPHILIZED LIPOSOMAL COMPOSITION FOR ADMINISTERING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER

Method of lyophilizing liposomes
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF RECONSTITUTING A LYOPHILIZED LIPOSOMAL COMPOSITION FOR ADMINISTERING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER

Method of lyophilizing liposomes
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF ADMINISTERING A RECONSTITUTED LIPOSOMAL COMPOSITION CONTAINING CYTARABINE AND DAUNORUBICIN TO TREAT NEWLY-DIAGNOSED THERAPY-RELATED AML (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PATIENTS 1 YEAR AND OLDER

Compositions for delivery of drug combinations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER

Liposomal formulations of anthracycline agents and cytidine analogs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER

Fixed drug ratios for treatment of hematopoietic cancers and proliferative disorders
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER

Liposomal formulations of anthracycline agents and cytidine analogs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER

Lipid carrier compositions with enhanced blood stability
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions for delivery of drug combinations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting VYXEOS

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
Exclusivity Expiration: ⤷  Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULTS WITH NEWLY DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC)
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Celator Pharms VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401-001 Aug 3, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 VYXEOS

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

International Patents for VYXEOS

See the table below for patents covering VYXEOS around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1065714 Compositions for delivery of drug combinations ⤷  Sign Up
South Korea 102452305 ⤷  Sign Up
Hong Kong 1201039 凍幹脂質體 (LYOPHILIZED LIPOSOMES) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VYXEOS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3300601 2290030-2 Sweden ⤷  Sign Up PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REG. NO/DATE: EU/1/18/1308 20180827
2768484 2019/054 Ireland ⤷  Sign Up PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
2768484 C201930069 Spain ⤷  Sign Up PRODUCT NAME: COMBINACION DE DAUNORUBICINA Y 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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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.