NDAINTRAVENOUSPOWDERPriority Review
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8
Mechanism of Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Class:
Nucleoside Metabolic Inhibitor
Clinical Trials (5)
VYxeoS Liposomal Italian Observational Study iN the Real Practice
Started Dec 2023
113 enrolled
Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia With Myelodysplasia-Related ChangesTherapy-Related Acute Myeloid Leukemia
Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms
Started Jan 2023
25 enrolled
Myeloid Neoplasm
Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
Started Feb 2022
22 enrolled
Acute Myeloid Leukemia With FLT3/ITD Mutation
Vyxeos® With Clofarabine for Pediatric AML
Started Nov 2020
25 enrolled
Relapsed Pediatric AMLRefractory Pediatric AML
CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome
Started Dec 2018
20 enrolled
Myelodysplastic Syndromes
Loss of Exclusivity
LOE Date
Apr 15, 2033
86 months away
Patent Expiry
Apr 15, 2033
Exclusivity Expiry
Sep 30, 2028
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 8518437 | Jun 7, 2026 | Product | — |
| 7850990 | Jan 23, 2027 | Product | U-3147 |
| 9271931 | Jan 23, 2027 | Product | — |
| 9271931*PED | Jul 23, 2027 | — | |
| 7850990*PED | Jul 23, 2027 | — |