Details for New Drug Application (NDA): 205625

Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 205625 describes ARNUITY ELLIPTA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. 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. Two 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:	8
Formulation / Manufacturing:	see details

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
Regulatory Exclusivity Expiration:	May 17, 2021
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:	Start Trial	Patent Expiration:	Aug 3, 2021	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	INDICATED FOR THE ONCE-DAILY MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN PATIENTS AGED 12 YEARS OF AGE AND OLDER
Patent:	Start Trial	Patent Expiration:	Aug 3, 2021	Product Flag?	Y	Substance Flag?		Delist Request?

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	205625-001	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

Serving leading biopharmaceutical companies globally:

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. 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.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.