TheraRadar
Data updated: May 26, 2026

PIZENSY (lactitol)

Gastrointestinal Approved 2020-02-12
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2020-02-12
Patent Cliff
2037

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
SOLUTION, FOR SOLUTION

Companies

BRAINTREE LABS
Active Ingredient: LACTITOL

PIZENSY Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2020 to 2021
Aug 2021 SUPPL
Label · Labeling
FDA Letter Label
Feb 2020 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What PIZENSY Treats

1 FDA approvals

Originally approved for its first indication in 2020 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PIZENSY FDA Label Details

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1 OB patents · 1 families · 1 international docs across 1 countries

PIZENSY Patents & Exclusivity

Latest Patent: May 2037

Patents (1 active)

US10806743 Expires May 12, 2037
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2037
  • • 2 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA211281 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.