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ARNUITY ELLIPTA Drug Patent 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-four 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.

DrugPatentWatch^® Generic Entry Outlook for Arnuity Ellipta

There has been one patent litigation case 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:	284
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	2
Patent Applications:	1,760
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
What excipients (inactive ingredients) are in ARNUITY ELLIPTA?	ARNUITY ELLIPTA excipients list
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

Pharmacology for ARNUITY ELLIPTA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ARNUITY ELLIPTA

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for ARNUITY ELLIPTA

ARNUITY ELLIPTA is protected by nine US patents and two FDA Regulatory Exclusivities.

Patents protecting ARNUITY ELLIPTA

FDA Regulatory Exclusivity protecting 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
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	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	205625-003	May 17, 2018
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-002	Aug 20, 2014
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-003	May 17, 2018
Glaxosmithkline	ARNUITY ELLIPTA	fluticasone furoate	POWDER;INHALATION	205625-001	Aug 20, 2014

International Patents for ARNUITY ELLIPTA

Country	Patent Number	Estimated Expiration
African Intellectual Property Organization (OAPI)	9393
Italy	1244655
Australia	2005274296
Czech Republic	285501
Malaysia	139577
World Intellectual Property Organization (WIPO)	0212266
South Korea	101387352

Supplementary Protection Certificates for ARNUITY ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	12/2008	Austria		PRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/07/434/001 - EU/1/07/434/003 20080111
1305329	SPC011/2008	Ireland		SPC011/2008: 20081105, EXPIRES: 20230110
1305329	CA 2008 00022	Denmark
1305329	C01305329/01	Switzerland		PRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1305329	326	Finland