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ARNUITY ELLIPTA Drug Profile

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When do Arnuity Ellipta patents expire, 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 sixty-three patent family members in forty-one countries.

The generic ingredient in ARNUITY ELLIPTA is fluticasone furoate. There are twenty-six 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 ARNUITY ELLIPTA

International Patents:	263
US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	14
Clinical Trials:	27
Patent Applications:	520
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARNUITY ELLIPTA
DailyMed Link:	ARNUITY ELLIPTA at DailyMed

Pharmacology for ARNUITY ELLIPTA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Synonyms for ARNUITY ELLIPTA

(1R,2S,8S,10S,11S,13R,14R,15S,17S)-1,8-DIFLUORO-14-{[(FLUOROMETHYL)SULFANYL]CARBONYL}-17-HYDROXY-2,13,15-TRIMETHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECA-3,6-DIEN-14-YL FURAN-2-CARBOXYLATE

(6|A,11|A,16|A,17|A)-6,9-Difluoro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methyl-3-oxoandrosta-1,4-diene-17-carbothioic Acid S-(Fluoromethyl) Ester

(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

397864-44-7

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

Avamys

BDBM50354851

CHEBI:74899

DB08906

DTXSID60228586

Flonase Sensimist

Flonase Sensimist Allergy Relief

Fluticasone fuorate

Fluticasone furancarboxylate

Fluticasone furoate

Fluticasone furoate (JAN/USAN/INN)

Fluticasone furoate [USAN:INN]

FLUTICASONEFUROATE

fluticasonum furoas

FT-0668768

Furamist

furoate de fluticasone

furoato de fluticasona

GSK 685 698

GSK 685698

GW 685698

GW 685698X

GW-685698

GW-685698X

GW6

gw685698

GW685698X

JS86977WNV

PL010437

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	205625-001	Aug 20, 2014		RX	Yes	Yes			Y	Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014		RX	Yes	Yes			Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014		RX	Yes	Yes			Y
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014		RX	Yes	Yes			Y

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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

Non-Orange Book US Patents for ARNUITY ELLIPTA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,858,593	Anti-inflammatory androstane derivative compositions
6,759,398	Anti-inflammatory androstane derivative
6,537,983	Anti-inflammatory androstane derivatives
7,592,329	Crystalline complexes of fluticasone-2-furoate

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International Patents for ARNUITY ELLIPTA

Country	Document Number	Estimated Expiration
South Africa	200509978
Australia	2001275760
China	100528256
World Intellectual Property Organization (WIPO)	2004009613

Supplementary Protection Certificates for ARNUITY ELLIPTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0014	France		PRODUCT NAME: FLUTICASONE FLUORATE; REG. NO/DATE: EU/1/07/434/001 20080111
0343	Netherlands		300343, 20210803, EXPIRES: 20230110
429	Luxembourg		91429, EXPIRES: 20230111
2008000029	Germany		PRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111