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.
US ANDA Litigation and Generic Entry Outlook for Vyxeos
Vyxeos was eligible for patent challenges on December 31, 1968.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 3, 2020. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VYXEOS
| International Patents: | 113 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 19 |
| 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;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 |
|---|---|
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| M.D. Anderson Cancer Center | Phase 1/Phase 2 |
| Fred Hutchinson Cancer Research 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 | 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 | |||
| >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 |
|---|---|---|
| Hong Kong | 1097194 | Start Trial |
| Australia | 2005235455 | Start Trial |
| Netherlands | 300960 | Start Trial |
| Japan | 6359717 | Start Trial |
| European Patent Office | 1458365 | Start Trial |
| Canada | 2852777 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VYXEOS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 2018C/045 | Belgium | Start Trial | PRODUCT NAME: VYXEOS (DAUNORUBICINE/CYTARABINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180823 |
| 2768484 | 301016 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
| 1744764 | 300960 | Netherlands | Start Trial | PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
| 1744764 | 18C1047 | France | Start Trial | PRODUCT NAME: DAUNORUBICINE + CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 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 |
