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Indacaterol maleate and glycopyrronium bromide
Indacaterol maleate and glycopyrronium bromide, marketed by Orion Corporation, Orion Pharma, is a combination therapy currently available in the respiratory market. The drug's key strength lies in its key composition patent, which is set to expire in 2028, providing a period of market exclusivity. The primary risk is the potential increase in competition following the patent expiry.
At a glance
| Generic name | Indacaterol maleate and glycopyrronium bromide |
|---|---|
| Sponsor | Orion Corporation, Orion Pharma |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (PHASE2)
- Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler (PHASE1)
- A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence (PHASE3)
- A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients (PHASE4)
- Prospective Cohort Study for the Real - Life Effectiveness Evaluation of GlycOpyrronium With IndacatERol Combination in the Management of COPD in Canada (POWER Study) (PHASE4)
- Assessment of Switching From Salmeterol/Fluticasone to Indacaterol/Glycopyrronium in a symtomaticCOPD Patient Cohort (PHASE4)
- Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen (PHASE4)
- Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients. (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |