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Data updated: Mar 10, 2026

AIRSUPRA

ALBUTEROL SULFATE Corticosteroid Hormone Receptor Agonists
Respiratory Approved 2023-01-10
2
Indications
--
Phase 3 Trials
3
Years on Market

Details

Status
Prescription
First Approved
2023-01-10
Routes
INHALATION
Dosage Forms
AEROSOL, METERED

Companies

Active Ingredient: ALBUTEROL SULFATE , BUDESONIDE

AIRSUPRA Approval History

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What AIRSUPRA Treats

2 indications

AIRSUPRA is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Asthma
  • Bronchoconstriction
Source: FDA Label

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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.

AIRSUPRA FDA Label Details

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Indications & Usage

FDA Label (PDF)

AIRSUPRA is indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older. AIRSUPRA is a combination of albuterol, a beta 2 -adrenergic agonist and budesonide, a corticosteroid, indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.

AIRSUPRA Patents & Exclusivity

Latest Patent: May 2030
Exclusivity: Sep 2028

Patents (1 active)

US9415009 Expires May 28, 2030

Exclusivity

M-317 Until Sep 2028
NP Until Jan 2026
Source: FDA Orange Book

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Data Sources

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