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Details for New Drug Application (NDA): 204275
» See Plans and Pricing
The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.
Summary for 204275
Tradename: | BREO ELLIPTA |
Applicant: | Glaxo Grp Ltd |
Ingredient: | fluticasone furoate; vilanterol trifenatate |
Patents: | 14 |
Generic Entry Opportunity Date for 204275
Generic Entry Date for 204275*:
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: 204275
Mechanism of Action | Corticosteroid Hormone Receptor Agonists Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 204275
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275 | NDA | GlaxoSmithKline LLC | 0173-0859 | 0173-0859-10 | 1 TRAY in 1 CARTON (0173-0859-10) > 1 INHALER in 1 TRAY > 30 POWDER in 1 INHALER |
BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275 | NDA | GlaxoSmithKline LLC | 0173-0859 | 0173-0859-14 | 1 TRAY in 1 CARTON (0173-0859-14) > 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 0.025MG BASE/INH | ||||
Approval Date: | May 10, 2013 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | May 15, 2020 | ||||||||
Regulatory Exclusivity Use: | INCLUSION OF DATA FROM THE SUMMIT STUDY FOR BREO ELLIPTA (FLUTICASONE FUROATE/VILANTEROL TRIFENATATE) INHALATION POWDER IN THE PACKAGE INSERT. | ||||||||
Patent: | Start Trial | Patent Expiration: | Aug 3, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS | ||||||||
Patent: | Start Trial | Patent Expiration: | Aug 3, 2021 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | INDICATED FOR THE ONCE-DAILY INHALED TREATMENT FOR ASTHMA IN ADULTS AGED 18 YEARS AND OLDER |
Expired US Patents for NDA 204275
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-001 | May 10, 2013 | Start Trial | Start Trial |
Glaxo Grp Ltd | BREO ELLIPTA | fluticasone furoate; vilanterol trifenatate | POWDER;INHALATION | 204275-002 | Apr 30, 2015 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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