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Last Updated: January 18, 2020

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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 twenty-seven patent family members in forty-six 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.

US ANDA Litigation and Generic Entry Outlook for Anoro Ellipta

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 29th, 2030. This may change due to patent challenges or generic licensing.

Summary for ANORO ELLIPTA
Drug patent expirations by year for ANORO ELLIPTA
Drug Prices for ANORO ELLIPTA

See drug prices for ANORO ELLIPTA

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
AstraZenecaPhase 2
ParexelPhase 2
ParexelPhase 4

See all ANORO ELLIPTA clinical trials

Pharmacology for ANORO ELLIPTA
Synonyms for ANORO ELLIPTA
Ellipta
GSK 573719
S900006130
Umeclidinium and vilanterol
Umeclidinium bromide / vilanterol
Umeclidinium bromide and vilanterol
Umeclidinium bromide mixture with vilanterol
Umeclidinium/vilanterol
Vilanterol / Umeclidinium

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   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
2506844 PA2018011 Lithuania   Start Trial PRODUCT NAME: UMEKLIDINAS + VILANTEROLIS + FLUTIKAZONO FUROATAS; REGISTRATION NO/DATE: EU/1/17/1236 20171115
1740177 122014000096 Germany   Start Trial PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
2506844 23/2018 Austria   Start Trial PRODUCT NAME: EIN PHARMAZEUTISCHES KOMBINATIONSPRODUKT, UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMECLIDINIUM, VILANTEROL ODER EINEM PHARMAZEUTISCH ANNEHMBAREN SALZ DAVON UND FLUTICASONFUROAT; REGISTRATION NO/DATE: EU/1/17/1236 (MITTEILUNG) 20171117
1425001 C 2014 016 Romania   Start Trial PRODUCT NAME: VILANTEROL SAU O SARE SAU SOLVAT AL ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF NATIONAL AUTHORISATION: 20131113; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF FIRST AUTHORISATION IN EEA: 20131113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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