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Last Updated: April 5, 2020

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ANORO ELLIPTA Drug Profile


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

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-four 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

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

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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
ParexelPhase 2
AstraZenecaPhase 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
>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
1425001 C01425001/01 Switzerland   Start Trial PRODUCT NAME: VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
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
1425001 2014/024 Ireland   Start Trial PRODUCT NAME: VILANTEROL OR A SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Medtronic
Boehringer Ingelheim
Johnson and Johnson
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.