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VYXEOS Drug Profile
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» See Plans and PricingWhen 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 eight patents protecting this drug.
This drug has one hundred and twenty-four patent family members in twenty-four 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
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 3, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VYXEOS
| International Patents: | 124 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 24 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VYXEOS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VYXEOS |
| DailyMed Link: | VYXEOS at DailyMed |
Generic Entry Opportunity Date for VYXEOS
Generic Entry Date for VYXEOS*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULTS WITH NEWLY DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) 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 |
|---|---|
| University of California, San Diego | Phase 2 |
| Children's Oncology Group | Phase 3 |
| National Cancer Institute (NCI) | Phase 3 |
Pharmacology for VYXEOS
| Drug Class | Nucleoside Metabolic Inhibitor Anthracycline Topoisomerase Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors Topoisomerase Inhibitors |
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 | ||||
| >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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013059133 | Start Trial |
| Netherlands | 300960 | Start Trial |
| Australia | 2002340670 | Start Trial |
| Austria | 373466 | Start Trial |
| Russian Federation | 2648753 | Start Trial |
| European Patent Office | 2120568 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VYXEOS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2768484 | 53/2019 | Austria | Start Trial | PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827 |
| 2768484 | 2019C/545 | Belgium | Start Trial | PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827 |
| 1744764 | 46/2018 | Austria | Start Trial | PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827 |
| 2768484 | LUC00135 | Luxembourg | Start Trial | PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827 |
| 2768484 | CA 2019 00051 | Denmark | Start Trial | PRODUCT NAME: KOMBINATION AF DAUNORUBICIN OG CYTARABIN; REG. NO/DATE: EU/1/18/1308 20180827 |
| 1744764 | 2018/042 | Ireland | Start Trial | PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180823 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
