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Pizensy

(Lactitol)

Small molecule

BBraintree Laboratories

0

Indications

1

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

1

Patents

Clinical

Trials by Indication[1]

Pneumonia1 trial

Pilot Study of the Effectiveness of Probiotics and Lactitol for the Decolonization of OXA-48 (Carbapenemase) Producing Klebsiella Pneumoniae Among Rectal Carriers

Unknown status·IInstituto de Investigación Hospital Universitario La Paz·Phase 2·NCT02307383·20 enrolled

Regulatory

FDA Approval Timeline[3]

Feb 12, 2020

PIZENSY

NDA NDA211281

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Lactitol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lactitol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA211281). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Pizensy. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Braintree Laboratories company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: BBraintree Laboratories

Patent Landscape[4]

Patent Cliff

May 12, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10806743May 12, 2037

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