Prescription medicine
Fluticasone and vilanterol Brand names: Breo; first approved as Breo Ellipta
Fluticasone and vilanterol (Breo Ellipta) is a prescription medicine with an FDA approval on record since 2013. No generic is listed; pharmacies paid $3.90 per unit (Fluticasone-vilanterol 100-25) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the fluticasone and vilanterol FDA label on DailyMed (effective November 7, 2024, GlaxoSmithKline LLC); the NDA 204275 record on Drugs@FDA; every fluticasone and vilanterol label on DailyMed.
Highlights of the record
FDA label of November 7, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for:
the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Forms and strengths
Powder.
On the market
- Earliest approval on file
- May 10, 2013 Breo Ellipta, Glaxo Grp Ltd; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- April 11, 2031 Breo Ellipta powder; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $3.90 per unit Fluticasone-vilanterol 100-25
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 35,760 through July 30, 2026
What is fluticasone and vilanterol used for?
From the label: indications and usageBREO ELLIPTA is a combination of fluticasone furoate, a corticosteroid, and vilanterol, a long-acting beta 2 -adrenergic agonist (LABA), indicated for:
the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 )
the maintenance treatment of asthma in patients aged 5 years and older. ( 1.2 ) Limitations of Use: Not indicated for relief of acute bronchospasm. […]
Conditions named in the indications of fluticasone and vilanterol's FDA labels, with every medicine labeled for each:
From other fluticasone and vilanterol labelsAsthma: Treatment of Asthma BREO ELLIPTA is indicated for the maintenance treatment of asthma in patients aged 5 years and older.
FDA pharmacologic class: Corticosteroid and beta2-Adrenergic Agonist.
Source: FDA drug label (Breo Ellipta), GlaxoSmithKline LLC, effective November 7, 2024 (SPL set 96428df1-ea05-431a-98d3-1ec2c4b63878), via openFDA; the full label on DailyMed
Is there a generic for fluticasone and vilanterol (Breo Ellipta)?
No generic fluticasone and vilanterol is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Breo Ellipta powder, the last expiring on April 11, 2031. 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
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluticasone and vilanterol (Breo Ellipta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.90 per unit (Fluticasone-vilanterol 100-25), up 1% from $3.85 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.
- Fluticasone-vilanterol 100-25 (generic)
- Breo ellipta 100-25 mcg inhalr (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fluticasone-vilanterol 100-25 | Generic | $3.90 per unit | n/a | +1% |
| Fluticasone-vilanterol 200-25 | Generic | $3.91 per unit | n/a | +2% |
| Breo ellipta 100-25 mcg inhalr | Brand | $5.93 per unit | n/a | -0.2% |
| Breo ellipta 200-25 mcg inhalr | Brand | $5.93 per unit | n/a | -0.3% |
| Breo ellipta 50-25 mcg inhaler | Brand | $6.48 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
What does the fluticasone and vilanterol label say about other medicines?
The fluticasone and vilanterol label names 14 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 |
|---|---|---|
| Arformoterol | warnings and precautions | Patients using BREO ELLIPTA should not use another therapy containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason. |
| Budesonide | warnings and precautions | Three (3) trials included adult and pediatric patients aged 12 years and older: 1 trial compared budesonide/formoterol with budesonide, 1 trial compared fluticasone propionate/salmeterol inhalation powder with fluticasone propionate inhalation powder, and 1 trial compared mometasone furoate/formoterol with mometasone … |
| Budesonide and formoterol | warnings and precautions | Three (3) trials included adult and pediatric patients aged 12 years and older: 1 trial compared budesonide/formoterol with budesonide, 1 trial compared fluticasone propionate/salmeterol inhalation powder with fluticasone propionate inhalation powder, and 1 trial compared mometasone furoate/formoterol with mometasone … |
| Clarithromycin | warnings and precautions | Interactions with Strong Cytochrome P450 3A4 Inhibitors Caution should be exercised when considering the coadministration of BREO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone … |
| Formoterol | warnings and precautions | Patients using BREO ELLIPTA should not use another therapy containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason. |
| Itraconazole | warnings and precautions | … strong CYP3A4 inhibitors (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and increased cardiovascular adverse effects may occur [see Drug … |
| Ketoconazole | drug interactions | Strong cytochrome P450 3A4 inhibitors (e.g., ketoconazole): Use with caution. May cause systemic corticosteroid and cardiovascular effects. |
| Mometasone | warnings and precautions | … propionate/salmeterol inhalation powder with fluticasone propionate inhalation powder, and 1 trial compared mometasone furoate/formoterol with mometasone furoate. |
| Nefazodone | warnings and precautions | … (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and increased cardiovascular adverse effects may occur [see Drug Interactions ( 7.1 ) … |
| Nelfinavir | warnings and precautions | … but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and increased cardiovascular adverse effects may occur [see Drug Interactions ( 7.1 ), Clinical … |
| Prednisone | warnings and precautions | Patients who have been previously maintained on 20 mg or more of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. |
| Ritonavir | warnings and precautions | Interactions with Strong Cytochrome P450 3A4 Inhibitors Caution should be exercised when considering the coadministration of BREO ELLIPTA with ketoconazole and other known strong CYP3A4 inhibitors (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone … |
| Salmeterol | warnings and precautions | Serious Asthma-Related Events – Hospitalizations, Intubations, Death Use of Long-acting Beta 2 -adrenergic Agonist (LABA) as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death [see Salmeterol Multicenter Asthma Research Trial (SMART)]. |
| Voriconazole | warnings and precautions | … conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and increased cardiovascular adverse effects may occur [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )]. |
Source: FDA drug label (Breo Ellipta), GlaxoSmithKline LLC, effective November 7, 2024 (SPL set 96428df1-ea05-431a-98d3-1ec2c4b63878), via openFDA; the full label on DailyMed
What do FAERS reports show for fluticasone and vilanterol?
The FDA Adverse Event Reporting System holds 35,760 reports that list fluticasone and vilanterol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,466 are coded as a death and 7,371 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 fluticasone and vilanterol?
20 other medicines are given the same way (respiratory (inhalation)) and in the same FDA class as fluticasone 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 |
|---|---|---|---|---|
| Albuterol | Asthma | 33 labelers | $0.0612 per mL 2.5 mg/3 mL solution | Resolved |
| Budesonide | Asthma | 13 labelers | $0.676 per mL 0.5 mg/2 mL suspension | No current entry |
| Albuterol and ipratropium | COPD | 14 labelers | $0.0787 per mL 0.5-3(2.5) mg/3 mL | No current entry |
| Budesonide and formoterol | Asthma, COPD | 2 labelers | $17.26 per gram 160-4.5 | 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 |
| Beclomethasone | Asthma | 2 labelers | $20.57 per gram 40 mcg | No current entry |
| Mometasone | Asthma | none listed | $6.84 per gram 50 mcg inhaler | No current entry |
Every medicine labeled for the same conditions as fluticasone and vilanterol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fluticasone and vilanterol compare with medicines for the same use?
1 side-by-side page set fluticasone and vilanterol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fluticasone and vilanterol
- 20 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Fluticasone and vilanterol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other