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Last Updated: March 29, 2024

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FLONASE SENSIMIST ALLERGY RELIEF Drug Patent Profile


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Which patents cover Flonase Sensimist Allergy Relief, and what generic alternatives are available?

Flonase Sensimist Allergy Relief is a drug marketed by Haleon Us Holdings and is included in one NDA. There are five 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

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Summary for FLONASE SENSIMIST ALLERGY RELIEF
Drug patent expirations by year for FLONASE SENSIMIST ALLERGY RELIEF
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Pharmacology for FLONASE SENSIMIST ALLERGY RELIEF
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 five US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FLONASE SENSIMIST ALLERGY RELIEF is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Fluid dispensing device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Fluid dispensing device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Fluid dispensing device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Fluid dispensing device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Fluid dispensing device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051-002 Aug 2, 2016 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051-002 Aug 2, 2016 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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
Australia 2001276497 ⤷  Try a Trial
Poland 213373 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2004009613 ⤷  Try a Trial
Australia 2003244450 FORMULATIONS FOR INHALATION ⤷  Try a Trial
South Korea 20070118298 A FLUID DISPENSING DEVICE ⤷  Try a Trial
South Korea 100889426 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FLONASE SENSIMIST ALLERGY RELIEF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 LUC00077 Luxembourg ⤷  Try a Trial 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
2506844 132018000000341 Italy ⤷  Try a 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 122008000029 Germany ⤷  Try a Trial PRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111
1519731 92269 Luxembourg ⤷  Try a Trial PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1305329 91429 Luxembourg ⤷  Try a Trial 91429, EXPIRES: 20230111
2506844 2018C/022 Belgium ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.