TheraRadar
Data updated: Mar 29, 2026

ASTEPRO

AZELASTINE HYDROCHRLORIDE
Approved 2008-10-15
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
4
Indications
--
Phase 3 Trials
1
Priority Reviews
17
Years on Market

Details

Status
Prescription
First Approved
2008-10-15
Routes
NASAL
Dosage Forms
SPRAY, METERED

Companies

MEDA PHARMS Viatris
Active Ingredient: AZELASTINE HYDROCHRLORIDE

ASTEPRO Approval History

Loading approval history...

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.

  • Hay Fever
  • Upper Respiratory Allergy
  • Nasal Congestion
  • Runny Nose
  • Sneezing
  • Itchy Nose
Source: FDA Label

Drugs Similar to ASTEPRO

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

ADVAIR DISKUS 500/50
FLUTICASONE PROPIONATE
6 shared
GSK
Shared indications:
Hay FeverUpper Respiratory AllergyNasal Congestion +3 more
FLOVENT DISKUS 100
FLUTICASONE PROPIONATE
6 shared
GSK
Shared indications:
Hay FeverUpper Respiratory AllergyNasal Congestion +3 more
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
FLUTICASONE PROPIONATE
6 shared
Teva
Shared indications:
Hay FeverUpper Respiratory AllergyNasal Congestion +3 more
ADVAIR DISKUS 100/50
FLUTICASONE PROPIONATE
5 shared
GSK
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
ADVAIR DISKUS 250/50
FLUTICASONE PROPIONATE
5 shared
GSK
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
BREZTRI AEROSPHERE
BUDESONIDE
5 shared
AstraZeneca
Shared indications:
Hay FeverNasal CongestionRunny Nose +2 more
BUDESONIDE
BUDESONIDE
5 shared
Teva
Shared indications:
Hay FeverNasal CongestionRunny Nose +2 more
ENTOCORT EC
BUDESONIDE
5 shared
PADAGIS US
Shared indications:
Hay FeverNasal CongestionRunny Nose +2 more
FLOVENT DISKUS 250
FLUTICASONE PROPIONATE
5 shared
GSK
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
FLOVENT DISKUS 50
FLUTICASONE PROPIONATE
5 shared
GSK
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATE
5 shared
ENCUBE
Shared indications:
Hay FeverNasal CongestionItchy Nose +2 more
RHINOCORT
BUDESONIDE
5 shared
KENVUE BRANDS
Shared indications:
Hay FeverNasal CongestionRunny Nose +2 more
SYMBICORT AEROSPHERE
BUDESONIDE
5 shared
AstraZeneca
Shared indications:
Hay FeverNasal CongestionRunny Nose +2 more
IMMPHENTIV
PHENYLEPHRINE HYDROCHLORIDE
3 shared
Hikma
Shared indications:
Nasal CongestionRunny NoseSneezing
KOVANAZE
OXYMETAZOLINE HYDROCHLORIDE
3 shared
ST RENATUS
Shared indications:
Nasal CongestionHay FeverUpper Respiratory Allergy
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
3 shared
GENUS
Shared indications:
Nasal CongestionRunny NoseSneezing
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
3 shared
Dr. Reddy's
Shared indications:
Nasal CongestionRunny NoseSneezing
VELTANE
BROMPHENIRAMINE MALEATE
3 shared
LANNETT
Shared indications:
Runny NoseSneezingHay Fever
TUXARIN ER
CHLORPHENIRAMINE MALEATE
2 shared
MAINPOINTE
Shared indications:
Hay FeverUpper Respiratory Allergy
AMMONIUM CHLORIDE IN PLASTIC CONTAINER
AMMONIUM CHLORIDE
1 shared
Pfizer
Shared indications:
Hay Fever
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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

Pro

ASTEPRO Patents & Exclusivity

Latest Patent: Jun 2028

Patents (4 active)

US8071073 Expires Jun 4, 2028
Source: FDA Orange Book

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

FDA Approval: NDA022371 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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