Details for New Drug Application (NDA): 205625
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The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.
Summary for 205625
Tradename: | ARNUITY ELLIPTA |
Applicant: | Glaxosmithkline |
Ingredient: | fluticasone furoate |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205625
Generic Entry Date for 205625*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971 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: 205625
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 205625
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625 | NDA | GlaxoSmithKline LLC | 0173-0874 | 0173-0874-10 | 1 INHALER in 1 CARTON (0173-0874-10) / 30 POWDER in 1 INHALER |
ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625 | NDA | GlaxoSmithKline LLC | 0173-0874 | 0173-0874-14 | 1 INHALER in 1 CARTON (0173-0874-14) / 14 POWDER in 1 INHALER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.1MG/INH | ||||
Approval Date: | Aug 20, 2014 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 5, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 11, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 2, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 205625
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