Breo ellipta, Relvar ellipta(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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Variants
Financial
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EMA approval date
Patent expiration date
Study first post date
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Results first post date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Combinations
Anoro ellipta, Breo ellipta, Trelegy ellipta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Umeclidinium bromide
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Vilanterol trifenatate
Fluticasone furoate
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Vilanterol trifenatate
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| anoro ellipta | New Drug Application | 2023-06-02 |
| breo ellipta | New Drug Application | 2024-11-07 |
| fluticasone furoate and vilanterol | NDA authorized generic | 2024-11-21 |
| trelegy ellipta | New Drug Application | 2023-06-02 |
Indications
FDA
EMA
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
No data
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 | 8 | 2 | 33 | 13 | 2 | 58 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | 1 | 30 | 10 | 2 | 44 |
| Asthma | D001249 | EFO_0000270 | J45 | 5 | 6 | 19 | 4 | — | 34 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | — | — | 14 | 7 | — | 21 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | 1 | 7 | 2 | — | 10 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
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
No data
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
No data
Variants
No data
Financial
Revenue by drug
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Trelegy ellipta – Innoviva
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Tabular view
Estimated US medical usage
Vilanterol acetate
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Umeclidinium
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Vilanterol
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Fluticasone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Vilanterol acetate
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Vilanterol
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Fluticasone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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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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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,053 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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58,116 adverse events reported
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