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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
Summary for FLONASE SENSIMIST ALLERGY RELIEF
| International Patents: | 287 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 25 |
| Patent Applications: | 546 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FLONASE SENSIMIST ALLERGY RELIEF |
| DailyMed Link: | FLONASE SENSIMIST ALLERGY RELIEF at DailyMed |
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 |
International Patents for FLONASE SENSIMIST ALLERGY RELIEF
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1305329 | Start Trial |
| Japan | 2005527497 | Start Trial |
| Israel | 177691 | Start Trial |
| Japan | 2005523268 | Start Trial |
| South Korea | 20050004845 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
