Data updated: Mar 29, 2026
ARMONAIR DIGIHALER
FLUTICASONE PROPIONATE
Approved 2017-01-27
2
Indications
--
Phase 3 Trials
1
Priority Reviews
9
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2017-01-27
- Routes
- INHALATION
- Dosage Forms
- POWDER
ARMONAIR DIGIHALER Approval History
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What ARMONAIR DIGIHALER Treats
2 FDA approvalsOriginally approved for its first indication in 2017 . Covers 2 distinct patient populations.
- Other (2)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
ARMONAIR DIGIHALER FDA Label Details
ProARMONAIR DIGIHALER Patents & Exclusivity
Latest Patent: Jan 2041
Patents (224 active)
US11173259*PED
Expires Jan 6, 2041
US11173259
Expires Jul 6, 2040
US11344685*PED
Expires Mar 26, 2040
US11969544*PED
Expires Feb 20, 2040
US11344685
Expires Sep 26, 2039
US11969544
Expires Aug 20, 2039
US10918816*PED
Expires Jun 14, 2036
US10918816
Expires Dec 14, 2035
US10195375*PED
Expires Aug 14, 2031
US10195375
Expires Feb 14, 2031
+ 214 more patents
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.