FLONASE SENSIMIST ALLERGY RELIEF Drug Patent Profile

Which patents cover Flonase Sensimist Allergy Relief, and when can generic versions of Flonase Sensimist Allergy Relief launch?

Flonase Sensimist Allergy Relief is a drug marketed by Glaxosmithkline Cons and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and twenty patent family members in twenty-three countries.

The generic ingredient in FLONASE SENSIMIST ALLERGY RELIEF is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.

DrugPatentWatch^® Generic Entry Outlook for Flonase Sensimist Allergy Relief

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 15, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FLONASE SENSIMIST ALLERGY RELIEF

International Patents:	120
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	29
Patent Applications:	1,760
Formulation / Manufacturing:	see details
DailyMed Link:	FLONASE SENSIMIST ALLERGY RELIEF at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for FLONASE SENSIMIST ALLERGY RELIEF

NDA:

022051

Dosage:

SPRAY, METERED;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for FLONASE SENSIMIST ALLERGY RELIEF

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for FLONASE SENSIMIST ALLERGY RELIEF

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 FLONASE SENSIMIST ALLERGY RELIEF

FLONASE SENSIMIST ALLERGY RELIEF is protected by five US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FLONASE SENSIMIST ALLERGY RELIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Cons	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Glaxosmithkline Cons	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Glaxosmithkline Cons	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Glaxosmithkline Cons	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Glaxosmithkline Cons	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y

Expired US Patents for FLONASE SENSIMIST ALLERGY RELIEF

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Cons	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016
Glaxosmithkline Cons	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016
Glaxosmithkline Cons	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016

International Patents for FLONASE SENSIMIST ALLERGY RELIEF

See the table below for patents covering FLONASE SENSIMIST ALLERGY RELIEF around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	342053
Slovakia	287576
World Intellectual Property Organization (WIPO)	2004024745
Brazil	0312230	Dispositivos dispensador de fluido para pulverizar um fluido para dentro de uma cavidade de corpo, e de descarga de fluido, e, montagem de alojamento para os mesmos
Spain	2292604
Hong Kong	1100916	A FLUID DISPENSING DEVICE
United Kingdom	0507224

Supplementary Protection Certificates for FLONASE SENSIMIST ALLERGY RELIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
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	C01305329/01	Switzerland		PRODUCT NAME: FLUTICASON FUROAT; REGISTRATION NUMBER/DATE: SWISSMEDIC 57968 19.12.2007
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
2506844	132018000000341	Italy		PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
2506844	2018C/022	Belgium		PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
2506844	18C1022	France		PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117