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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

BREO ELLIPTA Drug Patent Profile


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When do Breo Ellipta patents expire, 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 ninety-three 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. 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 May 21, 2025. This may change due to patent challenges or generic licensing.

Annual sales in 2019 were $2.6bn, 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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Drug patent expirations by year for BREO ELLIPTA
Drug Prices for BREO ELLIPTA

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Drug Sales Revenue Trends for BREO ELLIPTA

See drug sales revenues for BREO ELLIPTA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BREO ELLIPTA
Generic Entry Date for BREO ELLIPTA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Chiesi Farmaceutici S.p.A.Phase 4
Luis Puente MaestuPhase 4
Dr. Grace ParragaPhase 3

See all BREO ELLIPTA clinical trials

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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-001 May 10, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-001 May 10, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Glaxo Grp Ltd BREO ELLIPTA fluticasone furoate; vilanterol trifenatate POWDER;INHALATION 204275-002 Apr 30, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>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

International Patents for BREO ELLIPTA

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 0212266 ⤷  Free Forever Trial
Finland 911037 ⤷  Free Forever Trial
Singapore 150525 ⤷  Free Forever Trial
China 1622838 ⤷  Free Forever Trial
China 1294141 ⤷  Free Forever Trial
Austria A43791 ⤷  Free Forever Trial
United Kingdom 0418264 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for BREO ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 1890025-8 Sweden ⤷  Free Forever Trial PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
1305329 SPC011/2008 Ireland ⤷  Free Forever Trial SPC011/2008: 20081105, EXPIRES: 20230110
1425001 PA2014019,C1425001 Lithuania ⤷  Free Forever Trial PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1305329 326 Finland ⤷  Free Forever Trial
2506844 LUC00077 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
1425001 C20140013 00103 Estonia ⤷  Free Forever Trial PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013
1305329 300343 Netherlands ⤷  Free Forever Trial 300343, 20210803, EXPIRES: 20230110
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
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Harvard Business School
Baxter
McKinsey
Medtronic

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