FLONASE SENSIMIST ALLERGY RELIEF Drug Patent 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 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
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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
*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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FLONASE SENSIMIST ALLERGY RELIEF is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Fluid dispensing device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Fluid dispensing device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Fluid dispensing device
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Haleon Us Holdings | FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | SPRAY, METERED;NASAL | 022051-002 | Aug 2, 2016 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Haleon Us Holdings | FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | SPRAY, METERED;NASAL | 022051-002 | Aug 2, 2016 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Haleon Us Holdings | FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | SPRAY, METERED;NASAL | 022051-002 | Aug 2, 2016 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Haleon Us Holdings | FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | SPRAY, METERED;NASAL | 022051-002 | Aug 2, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Haleon Us Holdings | FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | SPRAY, METERED;NASAL | 022051-002 | Aug 2, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Portugal | 1539796 | ⤷ Sign Up | |
| Slovakia | 287576 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 03066036 | ⤷ Sign Up | |
| New Zealand | 523958 | 17.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derviative as anti-inflammatory agents | ⤷ Sign Up |
| Austria | E534589 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | 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 | 1890025-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117 |
| 1519731 | 92269 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE |
| 1305329 | 122008000029 | Germany | ⤷ Sign Up | PRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111 |
| 1305329 | 12/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/07/434/001 - EU/1/07/434/003 20080111 |
| >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.
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