TheraRadar
Data updated: May 26, 2026

TUXARIN ER (chlorpheniramine maleate)

Respiratory Approved 2015-06-22

TUXARIN ER is indicated for the treatment of Hay Fever; Allergic Rhinitis; Upper Respiratory Allergy.

Source: FDA Label • MAINPOINTE
1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Prescription
First Approved
2015-06-22
Patent Cliff
2032

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

TUXARIN ER Approval History

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

What TUXARIN ER Treats

3 indications

TUXARIN ER is approved for 3 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hay Fever
  • Allergic Rhinitis
  • Upper Respiratory Allergy
Source: FDA Label

TUXARIN ER Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to TUXARIN ER

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ADVAIR DISKUS 500/50
FLUTICASONE PROPIONATE
2 shared
GSK
Shared indications:
Hay FeverUpper Respiratory Allergy
ASTEPRO
AZELASTINE HYDROCHLORIDE
2 shared
Viatris
Shared indications:
Hay FeverUpper Respiratory Allergy
FLOVENT DISKUS 100
FLUTICASONE PROPIONATE
2 shared
GSK
Shared indications:
Hay FeverUpper Respiratory Allergy
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Active Pipeline

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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

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.

TUXARIN ER FDA Label Details

Indications & Usage

FDA Label (PDF)

TUXARIN ER is indicated for the treatment of Hay Fever; Allergic Rhinitis; Upper Respiratory Allergy.

View full patent landscape →
2 OB patents · 1 families · 10 international docs across 1 countries

TUXARIN ER Patents & Exclusivity

Latest Patent: Jan 2032

Patents (2 active)

US9066942 Expires Jan 3, 2032
US9107921 Expires Jan 3, 2032
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for TUXARIN ER

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2032
  • 2 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

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