DrugPatentWatch Database Preview
VYXEOS Drug Profile
When do Vyxeos patents expire, and when can generic versions of Vyxeos launch?
Vyxeos is a drug marketed by Celator Pharms and is included in one NDA. There are eight patents protecting this drug.
This drug has one hundred and thirteen patent family members in twenty-one 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.
Summary for VYXEOS
| International Patents: | 113 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 18 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VYXEOS |
| DailyMed Link: | VYXEOS at DailyMed |
Generic Entry Opportunity Date for VYXEOS
Generic Entry Date for VYXEOS*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT NDA:
Dosage:
POWDER;IV (INFUSION) |
*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 |
|---|---|
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| M.D. Anderson Cancer Center | Phase 1/Phase 2 |
| Ohio State University Comprehensive Cancer Center | Phase 2 |
Pharmacology for VYXEOS
| Drug Class | Nucleoside Metabolic Inhibitor Anthracycline Topoisomerase Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors Topoisomerase Inhibitors |
Synonyms for VYXEOS
| 1256639-86-7 |
| 5,12-Naphthacenedione, 8-acetyl-10-((3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-, (8S,10S)-, mixt. with 4-amino-1-beta-D-arabinofuranosyl-2(1H)-pyrimidinone |
| CPX 351 |
| CPX-351 |
| Cytarabine / daunonubicin |
| Cytarabine mixture with daunonubicin |
| Daunonubicin / cytarabine |
| Daunonubicin and cytarabine liposomal injection |
| Daunonubicin mixture with cytarabine |
| SCHEMBL3959238 |
US Patents and Regulatory Information for VYXEOS
| 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 | |||
| 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 | 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 |
International Patents for VYXEOS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 2005235455 | Start Trial |
| Portugal | 2120568 | Start Trial |
| Australia | 2004231977 | Start Trial |
| Portugal | 1443900 | Start Trial |
| Israel | 161214 | Start Trial |
| Spain | 2388064 | Start Trial |
| Japan | 4822666 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VYXEOS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 2768484 | 301016 | 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 |
| 1744764 | 46/2018 | Austria | Start Trial | PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827 |
| 1744764 | 122018000134 | Germany | Start Trial | PRODUCT NAME: ZUSAMMENSETZUNG AUS KOMPONENTE 1 DAUNORUBICIN MIT KOMPONENTE 2 CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 20180823 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
