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TRELEGY ELLIPTA Drug Profile

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When do Trelegy Ellipta patents expire, and what generic alternatives are available?

Trelegy Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are nineteen patents protecting this drug.

The generic ingredient in TRELEGY ELLIPTA is fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. There are twenty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; umeclidinium bromide; vilanterol trifenatate profile page.

Summary for TRELEGY ELLIPTA

US Patents:	19
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRELEGY ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRELEGY ELLIPTA
DailyMed Link:	TRELEGY ELLIPTA at DailyMed

Generic Entry Opportunity Date for TRELEGY ELLIPTA

NDA:

209482

Dosage:

POWDER;INHALATION

^*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 TRELEGY ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes			Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes			Y	Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes			Y

International Patents for TRELEGY ELLIPTA

Country	Document Number	Estimated Expiration
Japan	2005521673
Portugal	1305329
Germany	60311831
Netherlands	300343

Supplementary Protection Certificates for TRELEGY ELLIPTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2008000029	Germany		PRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111
2014 00021	Denmark		PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131114
6	Finland
1740177/03	Switzerland		PRODUCT NAME: UMECLIDINIUM BROMID; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014