Vilanterol acetate
Anoro, Anoro Ellipta, Ellipta, Laventair, Laventair Ellipta (vilanterol acetate) is a small molecule pharmaceutical. Vilanterol acetate was first approved as Breo ellipta on 2013-05-10. It has been approved in Europe to treat asthma and chronic obstructive pulmonary disease.
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Commercial
Therapeutic Areas
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FDA
EMA
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Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| anoro ellipta | New Drug Application | 2023-06-02 |
| breo ellipta | New Drug Application | 2023-05-12 |
| fluticasone furoate and vilanterol | NDA authorized generic | 2023-08-08 |
| trelegy ellipta | New Drug Application | 2023-06-02 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FLUTICASONE FUROATE / VILANTEROL TRIFENATATE, BREO ELLIPTA, GLAXO GRP LTD | |||
| 2026-11-13 | PED | ||
| 2026-05-13 | NPP, NS | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Fluticasone Furoate / Umeclidinium Bromide / Vilanterol Trifenatate, Trelegy Ellipta, Glaxosmithkline | |||
| 9750726 | 2030-11-29 | DP | |
| 11090294 | 2030-11-29 | U-3202, U-3203 | |
| 8746242 | 2030-10-11 | DP | |
| 8534281 | 2030-03-08 | DP | |
| 8161968 | 2028-02-05 | DP | |
| 7488827 | 2027-12-18 | DS, DP | |
| 9333310 | 2027-10-02 | DP | |
| 8511304 | 2027-06-14 | DP | U-1424, U-1476, U-1691, U-2954, U-3623 |
| 8183257 | 2025-07-27 | U-1476, U-2128, U-2129 | |
| 7439393 | 2025-05-21 | DS, DP | U-1401, U-1476, U-1691, U-2099, U-2100, U-2127, U-2957, U-3623 |
| 7498440 | 2025-04-27 | DS, DP | |
| 8309572 | 2025-04-27 | U-1476, U-2129 | |
| Fluticasone Furoate / Vilanterol Trifenatate, Breo Ellipta, Glaxo Grp Ltd | |||
| 11116721 | 2029-02-26 | DP | U-1401, U-1691, U-3623 |
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AK: Adrenergics inhalants in combination with corticosteroids or other drugs, excl. anticholinergics
— R03AK10: Vilanterol and fluticasone furoate
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL03: Vilanterol and umeclidinium bromide
— R03AL08: Vilanterol, umeclidinium bromide and fluticasone furoate
HCPCS
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Clinical
Clinical Trials
129 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 9 | 6 | 39 | 22 | 10 | 85 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | 2 | 35 | 12 | 6 | 56 |
| Asthma | D001249 | EFO_0000270 | J45 | 6 | 8 | 21 | 6 | 2 | 41 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 1 | 3 | 19 | 9 | 3 | 34 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | 1 | 7 | 3 | — | 11 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | 1 | — | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
| Respiratory tract diseases | D012140 | — | — | — | — | — | 1 | — | 1 |
| Respiration disorders | D012120 | — | J00-J99 | — | — | — | 1 | — | 1 |
| Chronic bronchitis | D029481 | — | J42 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | — | — | 1 | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | — | 1 | — | — | 1 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exercise tolerance | D017079 | — | — | — | — | — | — | 2 | 2 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Vilanterol acetate |
| INN | vilanterol |
| Description | Anoro, Anoro Ellipta, Ellipta, Laventair, Laventair Ellipta (vilanterol acetate) is a small molecule pharmaceutical. Vilanterol acetate was first approved as Breo ellipta on 2013-05-10. It has been approved in Europe to treat asthma and chronic obstructive pulmonary disease. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)O.OCc1cc([C@@H](O)CNCCCCCCOCCOCc2c(Cl)cccc2Cl)ccc1O |
Identifiers
| PDB | — |
| CAS-ID | 503068-35-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1084647 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 028LZY775B (ChemIDplus, GSRS) |
Target
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Trelegy ellipta – Innoviva
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Estimated US medical usage
Vilanterol acetate
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Umeclidinium
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Vilanterol
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Fluticasone
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Vilanterol acetate
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Vilanterol
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Fluticasone
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Price per prescription (USD)
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Vilanterol acetate
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Umeclidinium
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Vilanterol
Total medical expenditures per year (USD, in millions)
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Price per prescription (USD)
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Trends
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Additional graphs summarizing 2,013 documents
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Safety
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Adverse Events
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54,687 adverse events reported
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