TheraRadar
Data updated: Jul 17, 2026

ASTEPRO (azelastine hydrochrloride) · MEDA PHARMS

Respiratory Approved 2008-10-15

ASTEPRO is FDA-approved to treat 6 conditions.

4
Indications
--
Phase 3 Trials
1
Priority Reviews
17
Years on Market

Details

Status
Prescription
First Approved
2008-10-15
Patent Cliff
2028

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Routes
NASAL
Dosage Forms
SPRAY, METERED

Companies

Active Ingredient: AZELASTINE HYDROCHRLORIDE

ASTEPRO Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
22 FDA actions from 2008 to 2021 · 2 indication expansions
Jun 2021 SUPPL
Label · Labeling
Sep 2018 SUPPL
Label · Labeling
Sep 2015 SUPPL
Mfg · Manufacturing (CMC)

What ASTEPRO Treats

6 indications

ASTEPRO is approved for 6 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

ASTEPRO Competitive Set

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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 ASTEPRO

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FLOVENT DISKUS 100
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Hay FeverUpper Respiratory AllergyNasal Congestion +3 more
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Active Pipeline

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Key Completed Trials

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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.

ASTEPRO FDA Label Details

Indications & Usage

FDA Label (PDF)

ASTEPRO is FDA-approved to treat 6 conditions.

View full patent landscape →
1 OB patents · 1 families · 65 international docs across 25 countries

ASTEPRO Patents & Exclusivity

Latest Patent: Jun 2028

Patents (1 active)

US8071073 Expires Jun 4, 2028
Source: FDA Orange Book

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Revenue Insights

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  • Historical trend analysis

Patent Timeline

  • Cliff: 2028
  • 4 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.