Lumason

(Sulfur hexafluoride lipid-type A microspheres)

Small molecule

BBracco Diagnostics, Inc

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Appendicitis2 trials

The Role of Contrast Enhanced Ultrasound in Appendicitis

Completed·—·Phase 2·NCT03687502·37 enrolled

Contrast-Enhanced Ultrasound Diagnosis of Acute Appendicitis

Withdrawn·—·Phase 1·NCT03295656

COVID-191 trial

Contrast Enhanced Ultrasound in COVID-19

Completed·—·Phase 3·NCT04640038·4 enrolled

Injury1 trial

CEUS Evaluation of Hypoxic Ischemic Injury

Completed·—·Phase 3·NCT03549520·1 enrolled

Necrotizing Enterocolitis1 trial

CEUS Evaluation of Bowel Perfusion in Necrotizing Enterocolitis

Terminated·—·Phase 3·NCT03549507·1 enrolled

Regulatory

FDA Approval Timeline[3]

Oct 15, 2014

LUMASON

NDA NDA203684

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Sulfur hexafluoride lipid-type A microspheres. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sulfur hexafluoride lipid-type A microspheres compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA203684). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Lumason. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bracco Diagnostics, Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: BBracco Diagnostics, Inc

Patent Landscape[4]

Patent Cliff

Jul 6, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10232061Jul 6, 2038

10335502Jul 6, 2038

11723869May 15, 2039