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Harvard Business School
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Moodys

Last Updated: January 25, 2021

DrugPatentWatch Database Preview

FLONASE SENSIMIST ALLERGY RELIEF Drug Profile

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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 eight patents protecting this drug.

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

The generic ingredient in FLONASE SENSIMIST ALLERGY RELIEF 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 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 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

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Drug patent expirations by year for FLONASE SENSIMIST ALLERGY RELIEF
Generic Entry Opportunity Date for FLONASE SENSIMIST ALLERGY RELIEF
Generic Entry Date for FLONASE SENSIMIST ALLERGY RELIEF*:
Constraining patent/regulatory exclusivity:
NDA:
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.

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

Supplementary Protection Certificates for FLONASE SENSIMIST ALLERGY RELIEF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1305329 08C0014 France   Start Trial PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1305329 122008000029 Germany   Start Trial PRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111
2506844 132018000000341 Italy   Start Trial 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
1305329 91429 Luxembourg   Start Trial 91429, EXPIRES: 20230111
2506844 18C1022 France   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Dow
McKesson
Johnson and Johnson
McKinsey
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.