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ALBUTEROL SULFATE
Albuterol Sulfate is a marketed drug primarily indicated for the treatment or prevention of bronchospasm, holding a significant position in the respiratory care segment. A key strength of Albuterol Sulfate is its well-established mechanism and efficacy, supported by its long-standing market presence. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | ALBUTEROL SULFATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1982 |
Approved indications
- Bronchospasm Treatment or Prevention
- Exercise-Induced Bronchospasm Prevention
Common side effects
- Throat irritation
- Viral respiratory infections
- Upper respiratory inflammation
- Cough
- Musculoskeletal pain
- Ear, nose, and throat
- Lower respiratory
- Diarrhea
- Laryngitis
- Oropharyngeal edema
- Lung disorders
- Tachycardia
Key clinical trials
- A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations (PHASE3)
- High Flow Nasal Cannula Rates in Pediatric Asthma (NA)
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
- Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis (PHASE1, PHASE2)
- A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma (PHASE3)
- A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma (PHASE4)
- A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma (PHASE3)
- GRANITE: Airsupra Effectiveness in the Real World
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ALBUTEROL SULFATE CI brief — competitive landscape report
- ALBUTEROL SULFATE updates RSS · CI watch RSS