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Selenious Acid

(Fixed-dose trace element combination product of zinc, copper, and selenious acid)

Small molecule

AAmerican Regent, Inc.

0

Indications

2

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

2

Patents

Clinical

Trials by Indication[1]

GAN1 trial

Tralement Versus a Fixed-dose Trace Element Combination Product to Evaluate Manganese Safety

Withdrawn·AAmerican Regent, Inc.·Phase 4·NCT05661682

Age1 trial

Tralement vs. Fixed-dose Trace Element Combination Product in Patients >3 to 17 Years of Age Requiring Long-term PN

Withdrawn·AAmerican Regent, Inc.·Phase 4·NCT05677126

Regulatory

FDA Approval Timeline[3]

Aug 30, 2021

SELENIOUS ACID

NDA NDA209379

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Fixed-dose trace element combination product of zinc, copper, and selenious acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fixed-dose trace element combination product of zinc, copper, and selenious acid compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA209379). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Selenious Acid. U.S. Food & Drug Administration.
[5]
SEC EDGAR — American Regent, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: AAmerican Regent, Inc.

Patent Landscape[4]

Patent Cliff

Jul 1, 2041

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12150957Jul 1, 2041

11998565Jul 1, 2041

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