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TRELEGY ELLIPTA Drug Profile

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When do Trelegy Ellipta patents expire, and when can generic versions of Trelegy Ellipta launch?

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

This drug has four hundred and fifty-nine patent family members in forty-eight countries.

The generic ingredient in TRELEGY ELLIPTA is fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. There are twenty-seven 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

International Patents:	459
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

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Non-Orange Book US Patents for TRELEGY ELLIPTA

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
6,858,596	Formulation containing anti-inflammatory androstane derivative
9,144,571	Muscarinic acetylcholine receptor antagonists
6,750,210	Formulation containing novel anti-inflammatory androstane derivative

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International Patents for TRELEGY ELLIPTA

Country	Document Number	Estimated Expiration
Japan	2007526562
Israel	162700
Hungary	0303354

Supplementary Protection Certificates for TRELEGY ELLIPTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014038,C1740177	Lithuania		PRODUCT NAME: UMEKLIDINO BROMIDAS; REGISTRATION NO/DATE: EU/1/14/922 20140428
439	Luxembourg		PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI
2014019,C1425001	Lithuania		PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113