DrugPatentWatch Database Preview

BREO ELLIPTA Drug Profile

« Back to Dashboard

Which patents cover Breo Ellipta, and when can generic versions of Breo Ellipta launch?

Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are fourteen patents protecting this drug.

This drug has three hundred and sixty-nine patent family members in forty-two countries.

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

Summary for BREO ELLIPTA

International Patents:	369
US Patents:	14
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	33
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BREO ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREO ELLIPTA
DailyMed Link:	BREO ELLIPTA at DailyMed

Generic Entry Opportunity Date for BREO ELLIPTA

NDA:

204275

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.

Pharmacology for BREO ELLIPTA

Drug Class	beta2-Adrenergic Agonist Corticosteroid
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for BREO ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes			Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes			Y

Expired US Patents for BREO ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015

International Patents for BREO ELLIPTA

Country	Document Number	Estimated Expiration
Spain	2359244
Spain	2546830
World Intellectual Property Organization (WIPO)	2004011069

Supplementary Protection Certificates for BREO ELLIPTA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4 50004-2014	Slovakia		PRODUCT NAME: VILANTEROLTRIFENATAT; REGISTRATION NO/DATE: EU/1/13/886/001 - EU/1/13/886/006 20131113
2014 00021	Denmark		PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113
1425001/01	Switzerland		PRODUCT NAME: VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014