Prescription medicine
Umeclidinium and vilanterol Brand names: Anoro; first approved as Anoro Ellipta
Umeclidinium and vilanterol (Anoro Ellipta) is a prescription medicine with an FDA approval on record since 2013. No generic is listed; pharmacies paid $4.95 per umeclidinium-vilanterol ellipta 62.5-25 mcg inhaler in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the umeclidinium and vilanterol FDA label on DailyMed (effective June 2, 2023, GlaxoSmithKline LLC); the NDA 203975 record on Drugs@FDA; every umeclidinium and vilanterol label on DailyMed.
Highlights of the record
FDA label of June 2, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageANORO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Forms and strengths
Powder.
On the market
- Earliest approval on file
- December 18, 2013 Anoro Ellipta, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- November 29, 2030 Anoro Ellipta powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $4.95 per inhaler Umeclidinium-vilanterol ellipta 62.5-25 mcg inhaler
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest December 12, 2023
- FAERS reports
- 16,608 through July 30, 2026
What is umeclidinium and vilanterol used for?
From the label: indications and usageANORO ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Limitations of Use ANORO ELLIPTA is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma. The safety and effectiveness of ANORO ELLIPTA in asthma have not been established. ANORO ELLIPTA is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1 ) Limitations of Use: Not indicated for relief of acute bronchospasm or for the treatment of asthma.
Conditions named in the indications of umeclidinium and vilanterol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Anticholinergic and beta2-Adrenergic Agonist.
Source: FDA drug label (Anoro Ellipta), GlaxoSmithKline LLC, effective June 2, 2023 (SPL set 2dbd0671-c565-40c5-bf0f-e324db26799c), via openFDA; the full label on DailyMed
Is there a generic for umeclidinium and vilanterol (Anoro Ellipta)?
No generic umeclidinium and vilanterol is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Anoro Ellipta powder: the compound patent runs to December 18, 2027, and the last listed entry to November 29, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2013 earliest approval on file
- 2030 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for umeclidinium and vilanterol (Anoro Ellipta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $4.95 per Umeclidinium-vilanterol ellipta 62.5-25 mcg inhaler, up 2% from $4.87 on October 8, 2025. 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-vilanterol ellipta 62.5-25 mcg inhaler (generic)
- Anoro ellipta 62.5-25 mcg inhaler (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Umeclidinium-vilanterol ellipta 62.5-25 mcg inhaler | Generic | $4.95 per inhaler | n/a | +2% |
| Anoro ellipta 62.5-25 mcg inhaler | Brand | $7.91 per inhaler | n/a | -0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has umeclidinium and vilanterol been recalled?
The FDA's Enforcement Report lists 1 recall naming umeclidinium and vilanterol since 2023: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 12, 2023 | Class III | GlaxoSmithKline LLC | Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the umeclidinium and vilanterol label say about other medicines?
The umeclidinium and vilanterol label names 12 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Albuterol | warnings and precautions | Doses of the related beta 2 -adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. |
| Arformoterol | warnings and precautions | Patients using ANORO ELLIPTA should not use another therapy containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason. |
| Clarithromycin | warnings and precautions | Interactions with Strong Cytochrome P450 3A4 Inhibitors Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong cytochrome P450 3A4 (CYP3A4) inhibitors (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole … |
| Fluticasone | warnings and precautions | … infarction, and adjudicated on-treatment death due to cardiovascular events, was 2.2 per 100 patient-years for fluticasone furoate/umeclidinium/vilanterol 100/62.5/25 mcg (n = 4,151), 1.9 per 100 patient-years for fluticasone furoate/vilanterol 100/25 mcg (n = 4,134), and 2.2 per 100 patient-years for ANORO ELLIPTA (n … |
| Formoterol | warnings and precautions | Patients using ANORO ELLIPTA should not use another therapy containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason. |
| Itraconazole | warnings and precautions | … 3A4 (CYP3A4) inhibitors (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased cardiovascular adverse effects may occur [see Drug Interactions ( 7.1 ), Clinical … |
| Ketoconazole | drug interactions | Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. |
| Nefazodone | warnings and precautions | … (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased cardiovascular adverse effects may occur [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )]. |
| Nelfinavir | warnings and precautions | … but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased cardiovascular adverse effects may occur [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )]. |
| Ritonavir | warnings and precautions | Interactions with Strong Cytochrome P450 3A4 Inhibitors Caution should be exercised when considering the coadministration of ANORO ELLIPTA with ketoconazole and other known strong cytochrome P450 3A4 (CYP3A4) inhibitors (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole … |
| Salmeterol | warnings and precautions | Salmeterol Multicenter Asthma Research Trial (SMART) A 28-week, placebo-controlled, US trial that compared the safety of another LABA (salmeterol) with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in subjects receiving salmeterol (13/13,176 in subjects treated with … |
| Voriconazole | warnings and precautions | … conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased cardiovascular adverse effects may occur [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )]. |
Source: FDA drug label (Anoro Ellipta), GlaxoSmithKline LLC, effective June 2, 2023 (SPL set 2dbd0671-c565-40c5-bf0f-e324db26799c), via openFDA; the full label on DailyMed
What do FAERS reports show for umeclidinium and vilanterol?
The FDA Adverse Event Reporting System holds 16,608 reports that list umeclidinium and vilanterol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 843 are coded as a death and 2,998 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 and vilanterol?
15 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as umeclidinium and vilanterol or labeled mainly for the same use (COPD), the same class first. COPD lists all 23 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (respiratory (inhalation)) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fluticasone and salmeterol | COPD | 8 labelers | $1.07 per unit 100-50 | A presentation being discontinued |
| Albuterol and ipratropium | COPD | 14 labelers | $0.0787 per mL 0.5-3(2.5) mg/3 mL | No current entry |
| Budesonide and formoterol | COPD | 2 labelers | $17.26 per gram 160-4.5 | No current entry |
| Ipratropium | COPD | 13 labelers | $0.111 per mL 0.02% solution | No current entry |
| Arformoterol | COPD | 15 labelers | $0.633 per mL 15 mcg/2 mL solution | No current entry |
| Formoterol | COPD | 11 labelers | $1.30 per mL 20 mcg/2 mL neb vial | No current entry |
| Budesonide and formoterol and glycopyrrolate | COPD | none listed | $61.41 per gram 160-9-4.8 mcg | No current entry |
| Tiotropium | COPD | none listed | $126.08 per gram 1.25 mcg inhaler | No current entry |
Every medicine labeled for the same conditions as umeclidinium and vilanterol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does umeclidinium and vilanterol compare with medicines for the same use?
1 side-by-side page set umeclidinium and vilanterol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to umeclidinium and vilanterol
- 15 medicines for the same use
- Other anticholinergics
- the pharmacologic class, with prices and generics
- Umeclidinium and vilanterol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other