FLONASE Drug Patent Profile
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When do Flonase patents expire, and when can generic versions of Flonase launch?
Flonase is a drug marketed by Haleon Us Holdings and is included in three NDAs. There are four patents protecting this drug.
The generic ingredient in FLONASE 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
Indicators of Generic Entry
Summary for FLONASE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 86 |
Clinical Trials: | 24 |
Patent Applications: | 5,456 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for FLONASE |
Drug Sales Revenues: | Drug sales revenues for FLONASE |
What excipients (inactive ingredients) are in FLONASE? | FLONASE excipients list |
DailyMed Link: | FLONASE at DailyMed |
Recent Clinical Trials for FLONASE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Andover Research Eye Institute | Phase 4 |
University of South Florida | Phase 3 |
St. Paul's Sinus Centre | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for FLONASE
US Patents and Regulatory Information for FLONASE
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 | fluticasone propionate | SPRAY, METERED;NASAL | 020121-001 | Oct 19, 1994 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 ALLERGY RELIEF | fluticasone propionate | SPRAY, METERED;NASAL | 205434-001 | Jul 23, 2014 | OTC | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Haleon Us Holdings | FLONASE | fluticasone propionate | SPRAY, METERED;NASAL | 020121-001 | Oct 19, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FLONASE
See the table below for patents covering FLONASE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 3153379 | ⤷ Try a Trial | |
Czech Republic | 281275 | Karbothioáty androstanu (ANDROSTANE CARBOTHIOATES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEREOF) | ⤷ Try a Trial |
Canada | 1201114 | CARBOTHIOATES D'ANDROSTANE (ANDROSTANE CARBOTHIOATES) | ⤷ Try a Trial |
Italy | 8147792 | ⤷ Try a Trial | |
Austria | A17084 | ⤷ Try a Trial | |
Spain | 8207194 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FLONASE
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 |
1519731 | 13C0067 | France | ⤷ Try a Trial | 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 | 18C1022 | France | ⤷ Try a 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 |
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 |
2506844 | 1890025-8 | Sweden | ⤷ Try a Trial | 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 |
1305329 | SPC/GB08/026 | United Kingdom | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |