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breo ellipta Drug Patent Profile

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

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

This drug has two hundred and fourteen patent family members in thirty-two countries.

The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. 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; vilanterol trifenatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Breo Ellipta

Breo Ellipta was eligible for patent challenges on May 10, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 26, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2021 were $2.8bn, indicating a strong incentive for generic entry.

There have been two patent litigation cases 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

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Summary for breo ellipta

International Patents:	214
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	47
Patent Applications:	38
Drug Prices:	Drug price information for breo ellipta
Drug Sales Revenues:	Drug sales revenues for breo ellipta
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for breo ellipta
What excipients (inactive ingredients) are in breo ellipta?	breo ellipta excipients list
DailyMed Link:	breo ellipta at DailyMed

Drug patent expirations by year for breo ellipta

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for breo ellipta

Generic Entry Date for breo ellipta^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for breo ellipta

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Baylor Research Institute	Phase 4
Chiesi Farmaceutici S.p.A.	Phase 4
Luis Puente Maestu	Phase 4

See all breo ellipta clinical trials

Pharmacology for breo ellipta

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

US Patents and Regulatory Information for breo ellipta

breo ellipta is protected by seven US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of breo ellipta is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting breo ellipta

Pharmaceutical formulations comprising 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyet- hyl}-2-(hydroxymethyl) phenol
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Phenethanolamine derivatives for treatment of respiratory diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Manifold for use in medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Medicament dispenser
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting breo ellipta

NEW STRENGTH
Exclusivity Expiration: ⤷ Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	204275-003	May 12, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for breo ellipta

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

International Patents for breo ellipta

When does loss-of-exclusivity occur for breo ellipta?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Croatia

Patent: 0191257
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 21914
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 00950
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 00950
Patent: PRÉPARATIONS PHARMACEUTIQUES COMPRENANT 4-{(1R)-2-[(6-{2-[(2,6-DICHLOROBENZYL)OXY]ÉTHOXY}HEXYL)AMINO]-1-HYDROXYÉTHYL}-2-(HYDROXYMÉTHYL)-PHÉNOL (PHARMACEUTICAL FORMULATIONS COMPRISING 4-{(1 R)-2-[(6-{2-[(2,6-DICHLOROBENZYL)OXY]ETHOXY}HEXYL)AMINO]-1-HYDROXYETHYL}-2-(HYDROXYMETHYL)PHENOL)
Estimated Expiration: ⤷ Sign Up

Patent: 78169
Patent: PRÉPARATIONS PHARMACEUTIQUES COMPRENANT 4-{(1R)-2-[(6-{2-[(2,6-DICHLOROBENZYL)OXY]ÉTHOXY}HEXYL)AMINO]-1-HYDROXYÉTHYL}-2-(HYDROXYMÉTHYL)-PHÉNOL (PHARMACEUTICAL FORMULATIONS COMPRISING 4-{(1 R)-2-[(6-{2-[(2,6-DICHLOROBENZYL)OXY]ETHOXY}HEXYL)AMINO]-1-HYDROXYETHYL}-2-(HYDROXYMETHYL)PHENOL)
Estimated Expiration: ⤷ Sign Up

Hungary

Patent: 45917
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 09985
Estimated Expiration: ⤷ Sign Up

Patent: 12518663
Estimated Expiration: ⤷ Sign Up

Lithuania

Patent: 00950
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 00950
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 00950
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 00950
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 39352
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering breo ellipta around the world.

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Country	Patent Number	Title	Estimated Expiration
Denmark	2042168		⤷ Sign Up
European Patent Office	2067784	Dérivés de 17.béta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane utilisés comme anti-inflammatoires (17.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivatives as anti-inflammatory agents)	⤷ Sign Up
China	101084030	Medicament dispenser	⤷ Sign Up
Hong Kong	18895	Inhalation device	⤷ Sign Up
Hungary	E045371		⤷ Sign Up
Hungary	0303084	Gyulladásgátló hatású 17béta-karbotioát-17alfa-arilkarboniloxiloxi androsztán-származékok, eljárás az előállításukra, alkalmazásuk és ezeket tartalmazó gyógyszerkészítmények (17 BETA-CARBOTHIOATE 17-ALPHA-ARYLCARBONYLOXYLOXY ANDROSTANE DERIVATIVE AS ANTI-INFLAMMATORY AGENTS, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM)	⤷ Sign Up
European Patent Office	2042168	Formulation d'inhalation contenant des dérivés phénéthanolamines pour le traitement des maladies des voies respiratoires (Inhalation formulation comprising phenethanolamine derivatives for the treatment of respiratory diseases)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for breo ellipta

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	12/2008	Austria	⤷ Sign Up	PRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/07/434/001 - EU/1/07/434/003 20080111
1305329	SPC/GB08/026	United Kingdom	⤷ Sign Up	PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
1425001	132014902250414	Italy	⤷ Sign Up	PRODUCT NAME: VILANTEROLO O UN SUO SALE O SOLVATO(RELVAR ELLIPTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/886/001-006, 20131113
1519731	92269	Luxembourg	⤷ Sign Up	PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1425001	C20140013 00103	Estonia	⤷ Sign Up	PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013
1425001	14C0028	France	⤷ Sign Up	PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI,EN PARTICULIER LE TRIFENATATE DE VILANTEROL.; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1519731	132013902182575	Italy	⤷ Sign Up	PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

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Questions you can ask:

Summary for breo ellipta

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for breo ellipta

Recent Clinical Trials for breo ellipta

Pharmacology for breo ellipta

Patents protecting breo ellipta

FDA Regulatory Exclusivity protecting breo ellipta

When does loss-of-exclusivity occur for breo ellipta?

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for breo ellipta