INCRUSE ELLIPTA (umeclidinium bromide)
Incruse Ellipta (umeclidinium) is an anticholinergic indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is intended for maintenance therapy and is not indicated for the relief of acute bronchospasm.
How INCRUSE ELLIPTA Works
Umeclidinium is a long-acting muscarinic antagonist (LAMA), often referred to as an anticholinergic. It provides bronchodilation by competitively and reversibly inhibiting M3 receptors in the smooth muscle of the airways. This site-specific antagonism prevents acetylcholine-induced bronchoconstriction, providing a clinical effect that lasts longer than 24 hours.
Details
- Status
- Prescription
- First Approved
- 2014-04-30
- Patent Cliff
- 2027
- Routes
- INHALATION
- Dosage Forms
- POWDER
INCRUSE ELLIPTA Approval History
What INCRUSE ELLIPTA Treats
1 indicationsINCRUSE ELLIPTA is approved for 1 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Obstructive Pulmonary Disease
INCRUSE ELLIPTA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to INCRUSE ELLIPTA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02184611 results posted | 117410 | Ph 3 | completed | A 24 Week Efficacy Study of Inhaled Umeclidinium (UMEC) in Patients of Chronic Obstructive Pulmonary Disease (COPD) Using a Novel Dry Powder Inhaler (NDPI) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
INCRUSE ELLIPTA FDA Label Details
Indications & Usage
FDA Label (PDF)INCRUSE ELLIPTA is indicated for the treatment of Chronic Obstructive Pulmonary Disease.
INCRUSE ELLIPTA Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for INCRUSE ELLIPTA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.