TheraRadar
Data updated: May 26, 2026

TUZISTRA XR (chlorpheniramine polistirex)

Respiratory Approved 2015-04-30
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Discontinued
First Approved
2015-04-30
Patent Cliff
2029

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
SUSPENSION, EXTENDED RELEASE

Companies

TRIS PHARMA INC
Active Ingredient: CHLORPHENIRAMINE POLISTIREX , CODEINE POLISTIREX

TUZISTRA XR Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2015 to 2025
Dec 2025 SUPPL
Label · Labeling
FDA Letter Label
Dec 2023 SUPPL
Label · Labeling
FDA Letter Label
Jun 2018 SUPPL
Label · Labeling
FDA Letter Label

What TUZISTRA XR Treats

1 FDA approvals

Originally approved for its first indication in 2015 .

  • 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

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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.

TUZISTRA XR FDA Label Details

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2 OB patents · 1 families · 71 international docs across 15 countries

TUZISTRA XR Patents & Exclusivity

Latest Patent: Mar 2029

Patents (2 active)

US8062667 Expires Mar 29, 2029
US8790700 Expires Mar 15, 2027
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 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: NDA207768 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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