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Last Updated: April 17, 2021

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ANORO ELLIPTA Drug Profile

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

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

This drug has three hundred and thirty-seven patent family members in forty-seven countries.

The generic ingredient in ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide; vilanterol trifenatate profile page.

DrugPatentWatch® Generic Entry Outlook for Anoro Ellipta

Anoro 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 November 29, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ANORO ELLIPTA
International Patents:337
US Patents:14
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Clinical Trials: 38
Drug Prices: Drug price information for ANORO ELLIPTA
What excipients (inactive ingredients) are in ANORO ELLIPTA?ANORO ELLIPTA excipients list
DailyMed Link:ANORO ELLIPTA at DailyMed
Drug patent expirations by year for ANORO ELLIPTA
Drug Prices for ANORO ELLIPTA

See drug prices for ANORO ELLIPTA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ANORO ELLIPTA
Generic Entry Date for ANORO 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 ANORO ELLIPTA

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

SponsorPhase
Chiesi Farmaceutici S.p.A.Phase 4
Dr. Grace ParragaPhase 3
Pulmonary Research Institute of Southeast MichiganPhase 4

See all ANORO ELLIPTA clinical trials

Pharmacology for ANORO ELLIPTA

US Patents and Regulatory Information for ANORO ELLIPTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline ANORO ELLIPTA umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 203975-001 Dec 18, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ANORO ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1740177 C 2014 041 Romania   Start Trial PRODUCT NAME: BROMURADE UMECLIDINIUM4-[HIDROXI(DIFENIL)METIL]-1-{2-[(FENILMETIL)OXI]ETIL}-1-AZONIABICICLO[2.2.2]OCTAN; NATIONAL AUTHORISATION NUMBER: EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003; DATE OF NATIONAL AUTHORISATION: 20140428; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/922/001, EU/1/14/922/002, EU/1/14/922/003; DATE OF FIRST AUTHORISATION IN EEA: 20140428
1425001 C01425001/01 Switzerland   Start Trial PRODUCT NAME: VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
1425001 92439 Luxembourg   Start Trial PRODUCT NAME: VILANTEROL OU UN SEL OU UN SOLVATE DE CELUI-CI
1740177 2014/057 Ireland   Start Trial PRODUCT NAME: UMECLIDINIUM BROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
2506844 300942 Netherlands   Start Trial PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT OMVATTENDE EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BIJVOORBEELD UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BIJVOORBEELD VILANTEROLTRIFENATAAT) EN FLUTICASONFUROAAT; REGISTRATION NO/DATE: EU/1/17/1236 20171117
2506844 PA2018011 Lithuania   Start Trial PRODUCT NAME: UMEKLIDINAS + VILANTEROLIS + FLUTIKAZONO FUROATAS; REGISTRATION NO/DATE: EU/1/17/1236 20171115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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