TheraRadar
Data updated: Nov 8, 2026

ALBUTEROL SULFATE · AM THERAP

Generic · see PROAIR RESPICLICK Trial Activity: Declining 2 active trials
Respiratory Approved 1981-05-01

Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Teva Branded Pharmaceutical Products R&D, Inc. conducting 3 trials (13%)
25 indications explored (Broad Platform)
→ asthma (8 trials)
→ status asthmaticus (2 trials)
→ pompe disease (2 trials)
59
Indications
--
Phase 3 Trials
45
Years on Market

Details

Status
Prescription
First Approved
1981-05-01
Routes
ORAL, INHALATION
Dosage Forms
TABLET, SYRUP, SOLUTION, AEROSOL, METERED, TABLET, EXTENDED RELEASE

Companies

AM THERAP WATSON LABS Teva SENTISS BAUSCH WOCKHARDT EU OPERATN NEPHRON Novartis PLIVA MOVA Apotex PADAGIS US RISING Aurobindo Pharma WARNER CHILCOTT NATCO PHARMA USA COPLEY PHARM UCB INC LUOXIN AUROVITAS ADAPTIS LEXENPHARM RITEDOSE CORP STRIDES PHARMA INTL CHARTWELL MOLECULAR AMNEAL PHARMS AIZANT ACERTIS PHARMS CHARTWELL RX Cipla AMNEAL IRELAND LTD Sun Pharma Hikma ROXANE QUAGEN COSETTE PHARMS NC Lupin LANDELA PHARM ZYDUS PHARMS ARMSTRONG PHARMS PHARMOBEDIENT EPIC PHARMA LLC
Active Ingredient: ALBUTEROL SULFATE

ALBUTEROL SULFATE Approval History

1990
1991
1992
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1997
1998
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2001
2002
2003
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2005
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2025
2026
Original
New Indication
New Form
Label Update
430 FDA actions from 1989 to 2026
Sep 2026 SUPPL
Mfg · Manufacturing (CMC)
Apr 2026 ORIGINAL
Update
FDA Letter
Dec 2025 ORIGINAL
Update

What ALBUTEROL SULFATE Treats

3 indications

ALBUTEROL SULFATE is approved for 3 conditions since its original approval in 1989. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Bronchospasm
  • Obstructive Airway Disease
  • Exercise-Induced Bronchospasm

Same approved indications as PROAIR RESPICLICK (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

9 trials
Trial Sponsor ID Phase Status Title
NCT07426458 20251152 Ph 4 recruiting Ventilation and Perfusion in Asthmatics
NCT06052267 FpA-AS-30094 2023-505435-12-00, 2023 Ph 3 active not recruiting A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
NCT05035862 STUDY00002655 2709 Ph 1 terminated Mechanisms of Interferon Gamma-primed Mesenchymal Stromal Cells (MSCs) for Moderate-to-severe Persistent Asthma
NCT02969408 results posted ABS-AS-30064 Ph 3 completed A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma
NCT03586544 results posted 1131374-2 Ph 4 terminated Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
NCT03098680 PRIME PRIME (A094136) Ph 1 terminated A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
NCT02566252 PUL-042-003 Ph 1 completed Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)
NCT07721922 5482 Ph 4 not yet recruiting Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)
NCT07807007 CP006-ASTHMA SHXHH-CP006-CT-A01 CTR20254001 Ph 2 completed Efficacy and Safety of CP006 Inhalation Powder in Participants With Asthma
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

ALBUTEROL SULFATE FDA Label Details

Indications & Usage

FDA Label (PDF)

Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.

Looking for the branded version?

PROAIR RESPICLICK

Full clinical data, patents, trials, and competitive landscape for albuterol sulfate.

See PROAIR RESPICLICK

Data Sources

FDA Approval: ANDA072450 → Label: DailyMed → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment