Prescription medicine
Umeclidinium Brand names: Incruse; first approved as Incruse Ellipta
Umeclidinium (Incruse Ellipta) is a prescription medicine with an FDA approval on record since 2014. No generic is listed; pharmacies paid $7.35 per umeclidinium ellipta 62.5 mcg inhaler in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the umeclidinium FDA label on DailyMed (effective December 13, 2023, GlaxoSmithKline LLC); the NDA 205382 record on Drugs@FDA; every umeclidinium label on DailyMed.
Highlights of the record
FDA label of December 13, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageINCRUSE ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Forms and strengths
Aerosol (powder).
On the market
- Earliest approval on file
- April 30, 2014 Incruse Ellipta, Glaxo Grp England; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 18, 2027 Incruse Ellipta powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $7.35 per inhaler Umeclidinium ellipta 62.5 mcg inhaler
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,903 through July 30, 2026
What is umeclidinium used for?
From the label: indications and usageINCRUSE ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). INCRUSE ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Conditions named in the indications of umeclidinium's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anticholinergic.
Source: FDA drug label (Incruse Ellipta), GlaxoSmithKline LLC, effective December 13, 2023 (SPL set dbb64747-1505-49d7-9a33-99dd402e96d3), via openFDA; the full label on DailyMed
Is there a generic for umeclidinium (Incruse Ellipta)?
No generic umeclidinium is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Incruse Ellipta powder: the compound patent runs to December 18, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2027 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for umeclidinium (Incruse Ellipta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $7.35 per Umeclidinium ellipta 62.5 mcg inhaler. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Umeclidinium ellipta 62.5 mcg inhaler (generic)
- Incruse ellipta 62.5 mcg inhaler (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Umeclidinium ellipta 62.5 mcg inhaler | Generic | $7.35 per inhaler | n/a | n/a |
| Incruse ellipta 62.5 mcg inhaler | Brand | $10.79 per inhaler | n/a | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for umeclidinium?
The FDA Adverse Event Reporting System holds 8,903 reports that list umeclidinium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 649 are coded as a death and 2,402 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as umeclidinium?
2 other medicines are given the same way (oral) and in the same FDA class as umeclidinium or labeled mainly for the same use (COPD), the same class first. COPD lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tiotropium | COPD | 1 labeler | $11.81 per capsule 18 mcg capsule-inhaler | No current entry |
| Roflumilast | COPD | 16 labelers | $0.311 per tablet 500 mcg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does umeclidinium compare with medicines for the same use?
1 side-by-side page set umeclidinium beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Umeclidinium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other