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Cresemba

(Isavuconazonium)

Small molecule

0

Indications

1

Total Trials

0

Active Trials

0

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

6

Patents

Clinical

Trials by Indication[1]

Aspergillosis1 trial

Isavuconazole for the Prevention of COVID-19-associated Pulmonary Aspergillosis

Terminated·JJeffrey Jenks, MD, MPH·Phase 3·NCT04707703·8 enrolled

Regulatory

FDA Approval Timeline[3]

Mar 6, 2015

CRESEMBA

NDA NDA207501

Nov 22, 2022

CRESEMBA

NDA NDA207500

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Isavuconazonium. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Isavuconazonium compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA207500). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Cresemba. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: Astellas

Patent Landscape[4]

Patent Cliff

Sep 14, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

6812238Oct 31, 2025

6812238*PEDApr 30, 2026

10603280Sep 14, 2027

10206879Sep 14, 2027

10603280*PEDMar 14, 2028

1 more patents

10206879*PEDMar 14, 2028

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