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Fluticasone furoate; vilanterol trifenatate - Generic Drug Details

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Fluticasone furoate; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxo Grp Ltd and is included in one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and thirty patent family members in forty-one countries.

There are twenty-two drug master file entries for fluticasone furoate; vilanterol trifenatate. Three suppliers are listed for this compound.

Summary for Generic Name: fluticasone furoate; vilanterol trifenatate

Tradenames:1
Patents:14
Applicants:1
NDAs:1
Drug Master File Entries: see list22
Suppliers / Packagers: see list3
Clinical Trials: see list206
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fluticasone furoate; vilanterol trifenatate at DailyMed

Pharmacology for Ingredient: fluticasone furoate; vilanterol trifenatate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 2013RXYesYes7,439,393► subscribeYY ► subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 2015RXYesYes6,537,983► subscribeY ► subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 2013RXYesYes8,113,199► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: fluticasone furoate; vilanterol trifenatate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-001May 10, 20135,873,360► subscribe
Glaxo Grp Ltd
BREO ELLIPTA
fluticasone furoate; vilanterol trifenatate
POWDER;INHALATION204275-002Apr 30, 20155,873,360► subscribe
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Non-Orange Book Patents for Generic Ingredient: fluticasone furoate; vilanterol trifenatate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,787,532 Formulation containing anti-inflammatory androstane derivatives► subscribe
8,201,556Medicament dispenser► subscribe
7,592,329Crystalline complexes of fluticasone-2-furoate► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: fluticasone furoate; vilanterol trifenatate

Country Document Number Estimated Expiration
Australia2003281751► subscribe
Mexico2007001956► subscribe
China1315867► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C011/2008Ireland► subscribeSPC011/2008: 20081105, EXPIRES: 20230110
4 50004-2014Slovakia► subscribePRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
2014 00021Denmark► subscribePRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113
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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 verifification 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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