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Arcapta Neohaler (INDACATEROL)
Arcapta Neohaler (Indacaterol) is a small molecule beta2-adrenergic agonist developed by Novartis, targeting the beta-2 adrenergic receptor to treat asthma, bronchospasm prevention in COPD, chronic bronchitis, and emphysema. It was FDA-approved in 2011 and remains a branded product under Novartis ownership. Key safety considerations include its long half-life of 92.5 hours and moderate bioavailability of 43%. As of now, there are no generic manufacturers available. The commercial status of Arcapta Neohaler is patented.
At a glance
| Generic name | INDACATEROL |
|---|---|
| Sponsor | Novartis |
| Drug class | beta2-Adrenergic Agonist |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 2011 |
Approved indications
- Asthma
- Bronchospasm Prevention with COPD
- Prevention of Bronchospasm with Chronic Bronchitis
- Prevention of Bronchospasms with Emphysema
Common side effects
Drug interactions
- High Risk QT Prolonging Agents
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma (PHASE3)
- A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma. (PHASE3)
- Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma (PHASE3)
- A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (PHASE2)
- ANTES B+ Clinical Trial (PHASE4)
- A 24-week Prospective, Open-label, Multicenter, Single-arm rPMS Study in Real-world Setting for Atectura®
- Phase 1/Phase 2a Study of AERO-007 Inhalation Solution, a Nebulized LABA/LAMA Combination for Maintenance Treatment of COPD (PHASE1,PHASE2)
- Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Arcapta Neohaler CI brief — competitive landscape report
- Arcapta Neohaler updates RSS · CI watch RSS
- Novartis portfolio CI