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 nine 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.
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: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209401
Generic Entry Date for 209401*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER 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.
Pharmacology for NDA: 209401
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors Topoisomerase Inhibitors |
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: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MG;44MG | ||||
| Approval Date: | Aug 3, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 30, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Aug 3, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULTS WITH NEWLY DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) | ||||||||
| Regulatory Exclusivity Expiration: | Mar 30, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN PEDIATRIC PATIENTS AGES 1 YEAR AND OLDER | ||||||||
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