TheraRadar
Data updated: May 26, 2026

ASTEPRO ALLERGY (azelastine hydrochloride)

Respiratory Approved 2021-06-17
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Over-the-counter
First Approved
2021-06-17
Patent Cliff
2028

Pro Metrics

Patent cliff and revenue data

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Routes
NASAL
Dosage Forms
SPRAY, METERED

Companies

Bayer
Active Ingredient: AZELASTINE HYDROCHLORIDE

ASTEPRO ALLERGY Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2021 to 2025
Oct 2025 SUPPL
Label · Labeling
FDA Letter Label
Nov 2023 SUPPL
Label · Labeling
FDA Letter Label
Nov 2021 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter

What ASTEPRO ALLERGY Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

  • Other (1)
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT05887843 SAN-0791 2023-000362-34 Ph 1 terminated Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents and Young Adults With Seasonal Allergic Rhinitis
NCT04729517 HILARIA Aİ-2019-01 Ph 3 completed Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients
NCT00612118 IPR110982 Ph 2 completed A Phase II Study Evaluating Intranasal GSK256066 and Azelastine Hydrochloride in Subjects With Seasonal Allergic Rhinitis
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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.

ASTEPRO ALLERGY FDA Label Details

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1 OB patents · 1 families · 65 international docs across 25 countries

ASTEPRO ALLERGY Patents & Exclusivity

Latest Patent: Jun 2028

Patents (1 active)

US8071073 Expires Jun 4, 2028
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2028
  • • 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: NDA213872 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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