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-one 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. 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: | 141 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 5 |
| Clinical Trials: | 46 |
| Patent Applications: | 104 |
| 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 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
| Sponsor | Phase |
|---|---|
| Eastern Cooperative Oncology Group | Phase 2 |
| St. Jude Children's Research Hospital | Phase 2 |
| Thomas Jefferson University | 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 ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions for delivery of drug combinations
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULTS WITH NEWLY DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC)
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | 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 | ⤷ 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 | |||
| Celator Pharms | VYXEOS | cytarabine; daunorubicin | POWDER;INTRAVENOUS | 209401-001 | Aug 3, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 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 |
|---|---|---|---|
| Norway | 2019041 | ⤷ Try a Trial | |
| South Korea | 20140092323 | LYOPHILIZED LIPOSOMES | ⤷ Try a Trial |
| Hong Kong | 1097194 | LIPOSOMAL FORMULATIONS OF ANTHRACYCLINE AGENTS AND CYTIDINE ANALOGS | ⤷ Try a Trial |
| European Patent Office | 2768484 | LIPOSOMES LYOPHILISÉS (LYOPHILIZED LIPOSOMES) | ⤷ Try a Trial |
| South Korea | 20190111139 | 동결건조된 리포좀 (LYOPHILIZED LIPOSOMES) | ⤷ Try a Trial |
| South Korea | 102113753 | ⤷ Try a Trial | |
| Japan | 5314600 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VYXEOS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2768484 | 53/2019 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827 |
| 2768484 | 132019000000144 | Italy | ⤷ Try a Trial | PRODUCT NAME: DAUNORUBICINA E CITARABINA(VYXEOS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1308, 20180827 |
| 2768484 | SPC/GB19/067 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTERED: UK EU/1/18/1308(FOR NI) 20180827; UK PLGB 31626/0004 20180827 |
| 1744764 | C201830057 | Spain | ⤷ Try a 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 |
| 2768484 | 384 1-2020 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: KOMBINACIA DAUNORUBICINU A CYTARABINU; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
| 1744764 | SPC/GB18/045 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTERED: UK EU/1/18/1308/001-003 20180827; UK PLGB 31626/0004 20180827 |
| 2768484 | 19C1063 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON DE DAUNORUBICINE ET CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
| >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.
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