VYXEOS Drug Patent Profile
✉ Email this page to a colleague
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 thirty-three patent family members in twenty-five 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
Summary for VYXEOS
International Patents: | 133 |
US Patents: | 9 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 37 |
Patent Applications: | 169 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for VYXEOS |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VYXEOS |
What excipients (inactive ingredients) are in VYXEOS? | VYXEOS excipients list |
DailyMed Link: | VYXEOS at DailyMed |


DrugPatentWatch® Estimated Generic Entry Opportunity 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
Sponsor | Phase |
---|---|
Georgetown University | Phase 1/Phase 2 |
National Heart, Lung, and Blood Institute (NHLBI) | Phase 1/Phase 2 |
H. Lee Moffitt Cancer Center and Research Institute | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for VYXEOS
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 See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compositions for delivery of drug combinations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF ADULTS WITH NEWLY DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC)
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Celator Pharms | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401-001 | Aug 3, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Celator Pharms | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401-001 | Aug 3, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Celator Pharms | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401-001 | Aug 3, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Celator Pharms | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401-001 | Aug 3, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Celator Pharms | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401-001 | Aug 3, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for VYXEOS
See the table below for patents covering VYXEOS around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2002340670 | See Plans and Pricing | |
Japan | 6359717 | See Plans and Pricing | |
Australia | 2002340669 | See Plans and Pricing | |
Japan | 2005508920 | See Plans and Pricing | |
Hungary | S1900047 | See Plans and Pricing | |
Japan | 6133308 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VYXEOS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2768484 | 2019/054 | Ireland | See Plans and Pricing | PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
1744764 | 46/2018 | Austria | See Plans and Pricing | PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827 |
2768484 | C20190039 00312 | Estonia | See Plans and Pricing | PRODUCT NAME: DAUNORUBITSIIN/TSUETARABIIN;REG NO/DATE: EU/1/18/1308 27.08.2018 |
2768484 | C201930069 | Spain | See Plans and Pricing | 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 |
2768484 | 1990053-9 | Sweden | See Plans and Pricing | PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REG. NO/DATE: EU/1/18/1308 20180827 |
2768484 | 384 1-2020 | Slovakia | See Plans and Pricing | PRODUCT NAME: KOMBINACIA DAUNORUBICINU A CYTARABINU; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |