Details for New Drug Application (NDA): 205625
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NDA 205625 describes ARNUITY ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. Additional details are available on the ARNUITY ELLIPTA profile page.
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.
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: | 0 |
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 | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.2MG/INH | ||||
| Approval Date: | Aug 20, 2014 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.05MG/INH | ||||
| Approval Date: | May 17, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 1, 2026 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY HZA114971 | ||||||||
Expired US Patents for NDA 205625
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-001 | Aug 20, 2014 | 7,629,335 | ⤷ Try for Free |
| Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-002 | Aug 20, 2014 | 5,873,360 | ⤷ Try for Free |
| Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-003 | May 17, 2018 | 7,101,866 | ⤷ Try for Free |
| Glaxosmithkline | ARNUITY ELLIPTA | fluticasone furoate | POWDER;INHALATION | 205625-002 | Aug 20, 2014 | 7,101,866 | ⤷ Try for Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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