Last Updated: September 24, 2026

Details for New Drug Application (NDA): 205625

✉ Email this page to a colleague

NDA 205625 describes ARNUITY ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from two suppliers. Additional details are available on the ARNUITY ELLIPTA profile page.

The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There is one drug master file entry for this compound. Four 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

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

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.