Details for New Drug Application (NDA): 209482
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NDA 209482 describes TRELEGY ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the TRELEGY ELLIPTA profile page.
The generic ingredient in TRELEGY ELLIPTA is fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; umeclidinium bromide; vilanterol trifenatate profile page.
The generic ingredient in TRELEGY ELLIPTA is fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; umeclidinium bromide; vilanterol trifenatate profile page.
Summary for 209482
| Tradename: | TRELEGY ELLIPTA |
| Applicant: | Glaxosmithkline |
| Ingredient: | fluticasone furoate; umeclidinium bromide; vilanterol trifenatate |
| Patents: | 12 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209482
Generic Entry Date for 209482*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 209482
Suppliers and Packaging for NDA: 209482
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRELEGY ELLIPTA | fluticasone furoate; umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 209482 | NDA | GlaxoSmithKline LLC | 0173-0887 | 0173-0887-10 | 1 TRAY in 1 CARTON (0173-0887-10) / 1 INHALER in 1 TRAY / 30 POWDER in 1 INHALER |
| TRELEGY ELLIPTA | fluticasone furoate; umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 209482 | NDA | GlaxoSmithKline LLC | 0173-0887 | 0173-0887-14 | 1 TRAY in 1 CARTON (0173-0887-14) / 1 INHALER in 1 TRAY / 14 POWDER in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | ||||
| Approval Date: | Sep 18, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Nov 29, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MAINTENANCE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) COMPRISING THE ONCE PER DAY ADMINISTRATION OF TRELEGY ELLIPTA, 100 MCG FLUTICASONE FUROATE/62.5 MCG UMECLIDINIUM/25 MCG VILANTEROL | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Nov 21, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 18, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 209482
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | TRELEGY ELLIPTA | fluticasone furoate; umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 209482-002 | Sep 9, 2020 | ⤷ Subscribe | ⤷ Subscribe |
| Glaxosmithkline | TRELEGY ELLIPTA | fluticasone furoate; umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 209482-002 | Sep 9, 2020 | ⤷ Subscribe | ⤷ Subscribe |
| Glaxosmithkline | TRELEGY ELLIPTA | fluticasone furoate; umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 209482-002 | Sep 9, 2020 | ⤷ Subscribe | ⤷ Subscribe |
| Glaxosmithkline | TRELEGY ELLIPTA | fluticasone furoate; umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 209482-001 | Sep 18, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Glaxosmithkline | TRELEGY ELLIPTA | fluticasone furoate; umeclidinium bromide; vilanterol trifenatate | POWDER;INHALATION | 209482-001 | Sep 18, 2017 | ⤷ Subscribe | ⤷ Subscribe |
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