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ARNUITY ELLIPTA Drug Profile

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Which patents cover Arnuity Ellipta, and what generic alternatives are available?

Arnuity Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are eight patents protecting this drug.

This drug has two hundred and eighty-three patent family members in forty-one countries.

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.

US ANDA Litigation and Generic Entry Outlook for Arnuity Ellipta

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ARNUITY ELLIPTA

International Patents:	283
US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	19
Clinical Trials:	2
Patent Applications:	540
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ARNUITY ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARNUITY ELLIPTA
DailyMed Link:	ARNUITY ELLIPTA at DailyMed

See drug prices for ARNUITY ELLIPTA

Recent Clinical Trials for ARNUITY ELLIPTA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Virginia	Phase 2
GlaxoSmithKline	Phase 3

See all ARNUITY ELLIPTA clinical trials

Recent Litigation for ARNUITY ELLIPTA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2015-09-08
GlaxoSmithKline Intellectual Property Management Limited v. Sandoz Inc.

See all ARNUITY ELLIPTA litigation

Pharmacology for ARNUITY ELLIPTA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Synonyms for ARNUITY ELLIPTA

(6alpha,11alpha,14beta,16alpha,17alpha)-6,9-Difluoro-17-{[(Fluoromethyl)sulfanyl]carbonyl}-11-Hydroxy-16-Methyl-3-Oxoandrosta-1,4-Dien-17-Yl Furan-2-Carboxylate

(6alpha,11beta,16alpha,17alpha)-6,9-Difluoro-17-(((fluoromethyl)thio)carbonyl)-11-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17-yl-2-furancarboxylate

397864-44-7

6alpha,9-Difluoro-17-(((fluoromethyl)sulfanyl)carbonyl)-11beta-hydroxy-16alpha-methyl-3-oxoandrosta-1,4-dien-17alpha-yl furan-2-carboxylate

6alpha,9-difluoro-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-11beta-hydroxy-16-methyl-3-oxoandrosta-1,4-dien-17alpha-yl 2-furoate

779352-12-4

911210-90-7

Alisade

Allermist

Androsta-1,4-diene-17-carbothioic acid, 6,9-difluoro-17-((2- furanylcarbonyl)oxy)-11-hydroxy-16-methyl-3-oxo-, S-(fluoromethyl) ester, (6alpha,11beta,16alpha,17alpha)-

Avamys

Avamys pound>> Veramyst pound>> Allermist

BCP18136

BDBM50354851

CHEBI:74899

CHEMBL1676

D06315

DB08906

DTXSID60228586

Flonase Sensimist

Flonase Sensimist Allergy Relief

fluticason furoate

Fluticasone fuorate

Fluticasone furancarboxylate

Fluticasone furoate

Fluticasone furoate (JAN/USAN/INN)

Fluticasone furoate [USAN:INN]

fluticasonum furoas

FT-0668768

Furamist

furoate de fluticasone

furoato de fluticasona

GSK 685 698

GSK 685698

GSK-685968

GSK685968

GW 685698

GW 685698X

GW-685698

GW-685698X

GW6

gw685698

GW685698X

JS86977WNV

Q2166700

s6487

SCHEMBL140504

UNII-JS86977WNV

Veramyst

Veramyst (TN)

ZINC3992105

US Patents and Regulatory Information for ARNUITY ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018		RX	Yes	Yes			Y	Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014		RX	Yes	Yes
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014		RX	Yes	Yes			Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018		RX	Yes	Yes			Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018		RX	Yes	Yes			Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014		RX	Yes	Yes			Y

Expired US Patents for ARNUITY ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014

International Patents for ARNUITY ELLIPTA

Country	Patent Number	Estimated Expiration
European Patent Office	1730676
China	100528256
Norway	342839
Japan	2005537278
China	100513416
Brazil	PI0507714

Supplementary Protection Certificates for ARNUITY ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	1890025-8	Sweden		PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
1305329	300343	Netherlands		300343, 20210803, EXPIRES: 20230110
1305329	91429	Luxembourg		91429, EXPIRES: 20230111
1305329	326	Finland
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111