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Velphoro

(sucroferric oxyhydroxide)

Small molecule

0

Indications

3

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

22

Patents

Clinical

Trials by Indication[1]

Peritoneal Dialysis (PD)1 trial

Non-interventional Study to Investigate the Short and Long Term Real-life Safety, Effectiveness, and Adherence of Velphoro® in Patients With Hyperphosphataemia Undergoing Haemodialysis (HD) or Peritoneal Dialysis (PD)

Completed·VVifor Fresenius Medical Care Renal Pharma··NCT02687594·1,400 enrolled

Interaction1 trial

Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders

Completed·SSIGA Technologies·Phase 4·NCT04485039·44 enrolled

Peritoneal Dialysis1 trial

Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients

Completed·UUniversity of Colorado, Denver·Phase 4·NCT04046263·17 enrolled

Regulatory

FDA Approval Timeline[3]

Nov 27, 2013

VELPHORO

NDA NDA205109

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for sucroferric oxyhydroxide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — sucroferric oxyhydroxide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA205109). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Velphoro. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Vifor Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: VVifor Pharma

Patent Landscape[4]

Patent Cliff

Nov 13, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10682376Nov 13, 2028

10925896Nov 13, 2028

10695367Nov 13, 2028

11013761Nov 13, 2028

10933090Nov 13, 2028

17 more patents

10925897Nov 13, 2028

11013762Nov 13, 2028

10925897*PEDMay 13, 2029

10695367*PEDMay 13, 2029

11013761*PEDMay 13, 2029

10682376*PEDMay 13, 2029

10933090*PEDMay 13, 2029

11013762*PEDMay 13, 2029

10925896*PEDMay 13, 2029

9561251Jan 23, 2030

9561251*PEDJul 23, 2030

11446252Nov 26, 2034

11234938Nov 26, 2034

10624855Nov 26, 2034

10624855*PEDMay 26, 2035

11234938*PEDMay 26, 2035

11446252*PEDMay 26, 2035

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