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Details for New Drug Application (NDA): 204275
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NDA 204275 describes BREO ELLIPTA, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from two suppliers. There are fourteen patents protecting this drug. Additional details are available on the BREO ELLIPTA profile page.
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.
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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