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VYXEOS Drug Profile
» See Plans and Pricing
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 twenty-eight 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 August 3, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VYXEOS
| International Patents: | 128 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 28 |
| 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 |
| 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:
FDA exclusivity 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 |
|---|---|
| Massachusetts General Hospital | Phase 2 |
| AbbVie | Phase 2 |
| University of California, San Diego | Phase 2 |
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
International Patents for VYXEOS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 112014009305 | Get Started for $10 |
| Hungary | S1900047 | Get Started for $10 |
| World Intellectual Property Organization (WIPO) | 03028697 | Get Started for $10 |
| Canada | 2522662 | Get Started for $10 |
| Hong Kong | 1253378 | Get Started for $10 |
| Japan | 2010180210 | Get Started for $10 |
| >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 | Get Started for $10 | PRODUCT NAME: VYXEOS (DAUNORUBICINE/CYTARABINE); AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180823 |
| 1744764 | 46/2018 | Austria | Get Started for $10 | PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827 |
| 2768484 | 2019/054 | Ireland | Get Started for $10 | PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
| 1744764 | C201830057 | Spain | Get Started for $10 | 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 | 19C1063 | France | Get Started for $10 | PRODUCT NAME: COMBINAISON DE DAUNORUBICINE ET CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827 |
| 1744764 | 122018000134 | Germany | Get Started for $10 | 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 |
