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Generated: August 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209401

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NDA 209401 describes VYXEOS, which is a drug marketed by Celator Pharms and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the VYXEOS profile page.

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 209401
Tradename:VYXEOS
Applicant:Celator Pharms
Ingredient:cytarabine; daunorubicin
Patents:8
Generic Entry Opportunity Date for 209401
Generic Entry Date for 209401*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
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.

Pharmacology for NDA: 209401
Suppliers and Packaging for NDA: 209401
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401 NDA Jazz Pharmaceuticals, Inc. 68727-745 68727-745-01 20 mL in 1 VIAL (68727-745-01)
VYXEOS cytarabine; daunorubicin POWDER;INTRAVENOUS 209401 NDA Jazz Pharmaceuticals, Inc. 68727-745 68727-745-02 40 mL in 1 CARTON (68727-745-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength100MG;44MG
Approval Date:Aug 3, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 3, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Sep 29, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING A RECONSTITUTED LIPOSOMAL COMPOSITION CONTAINING CYTARABINE AND DAUNORUBICIN TO TREAT ADULTS WITH NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC)
Patent:➤ Sign UpPatent Expiration:Sep 29, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF RECONSTITUTING A LYOPHILIZED LIPOSOMAL COMPOSITION FOR ADMINISTERING CYTARABINE AND DAUNORUBICIN TO TREAT ADULTS WITH NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC)

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