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Bafiertam

(L-N-monomethyl arginine acetate (L-NMMA))

Small molecule

0

Indications

1

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

21

Patents

Clinical

Trials by Indication[1]

Chronic Kidney Disease1 trial

Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)

Terminated· GSK logo

GSK·Phase 2·NCT03446612·6 enrolled

Regulatory

FDA Approval Timeline[3]

Apr 28, 2020

BAFIERTAM

NDA NDA210296

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for L-N-monomethyl arginine acetate (L-NMMA). U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — L-N-monomethyl arginine acetate (L-NMMA) compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA210296). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Bafiertam. U.S. Food & Drug Administration.
[5]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: GSK

Patent Landscape[4]

Patent Cliff

Feb 27, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11903918Feb 27, 2035

10918615Feb 27, 2035

10918616Feb 27, 2035

11590095Feb 27, 2035

9511043Feb 27, 2035

16 more patents

9326965Feb 27, 2035

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10105336Feb 27, 2035

9820961Feb 27, 2035

10098863Feb 27, 2035

9517209Feb 27, 2035

9566259Feb 27, 2035

9326947Feb 27, 2035

10105335Feb 27, 2035

10105337Feb 27, 2035

10918617Feb 27, 2035

9636319Feb 27, 2035

10945985Feb 27, 2035

9820960Feb 27, 2035

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