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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 Haleon Us Holdings and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-one 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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for FLONASE SENSIMIST ALLERGY RELIEF

International Patents:	121
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	41
Patent Applications:	1,426
DailyMed Link:	FLONASE SENSIMIST ALLERGY RELIEF at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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

Paragraph IV (Patent) Challenges for FLONASE SENSIMIST ALLERGY RELIEF

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FLONASE SENSIMIST ALLERGY RELIEF	Nasal Spray	fluticasone furoate	27.5 mcg	022051	1	2011-07-15

US Patents and Regulatory Information for FLONASE SENSIMIST ALLERGY RELIEF

FLONASE SENSIMIST ALLERGY RELIEF is protected by four 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
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016		OTC	Yes	Yes			Y
Haleon Us Holdings	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
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016
Haleon Us Holdings	FLONASE SENSIMIST ALLERGY RELIEF	fluticasone furoate	SPRAY, METERED;NASAL	022051-002	Aug 2, 2016

EU/EMA Drug Approvals for FLONASE SENSIMIST ALLERGY RELIEF

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GlaxoSmithKline (Ireland) Limited	Avamys	fluticasone furoate	EMEA/H/C/000770 Adults, adolescents (12 years and over) and children (6-11 years). Avamys is indicated for the treatment of the symptoms of allergic rhinitis.	Authorised	no	no	no	2008-01-11
Glaxo Group Ltd.	Alisade	fluticasone furoate	EMEA/H/C/001019 Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.	Withdrawn	no	no	no	2008-10-06

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
European Patent Office	1471900	FORMULATION PHARMACEUTIQUE S'ADMINISTRANT PAR INHALATION ET CONTENANT UN DERIVE D'ANDROSTANE ET UN BETA-2-ADRENORECEPTEUR POUR TRAITER DES ETATS INFLAMMATOIRES ET ALLERGIQUES (PHARMACEUTICAL FORMULATION FOR ADMINISTRATION BY INHALATION COMPRISING AN ANDROSTANE DERIVATIVE AND A BETA-2-ADRENORECEPTOR AGONIST FOR THE TREATMENT OF INFLAMMATORY AND ALLERGIC CONDITIONS)
Norway	20075156
Mexico	PA05000821	DISPOSITIVO DISTRIBUIDOR DE FLUIDO. (A FLUID DISPENSING DEVICE.)

Supplementary Protection Certificates for FLONASE SENSIMIST ALLERGY RELIEF

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	122008000029	Germany		PRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111
1305329	C 2008 007	Romania		PRODUCT NAME: FUROATDE FLUTICAZONA SI SOLVATIIACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/07/434/001; DATE OF NATIONAL AUTHORISATION: 20080111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/434/001, EU/1/07/434/002, EU/1/07/434/003; DATE OF FIRST AUTHORISATION IN EEA: 20080111
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527