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Last Updated: February 27, 2021

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TRELEGY ELLIPTA Drug Profile

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

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

This drug has five hundred and five patent family members in fifty-two countries.

The generic ingredient in TRELEGY ELLIPTA is fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluticasone furoate; umeclidinium bromide; vilanterol trifenatate profile page.

US ANDA Litigation and Generic Entry Outlook for Trelegy Ellipta

Trelegy 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.

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 TRELEGY ELLIPTA
Drug Prices for TRELEGY ELLIPTA

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Generic Entry Opportunity Date for TRELEGY ELLIPTA
Generic Entry Date for TRELEGY 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 TRELEGY ELLIPTA

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

SponsorPhase
GlaxoSmithKlinePhase 4

See all TRELEGY ELLIPTA clinical trials

US Patents and Regulatory Information for TRELEGY ELLIPTA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-002 Sep 9, 2020 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 TRELEGY ELLIPTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1305329 12/2008 Austria   Start Trial PRODUCT NAME: FLUTICASON FUROAT UND DESSEN SOLVATE; REGISTRATION NO/DATE: EU/1/07/434/001 - EU/1/07/434/003 20080111
2506844 CA 2018 00023 Denmark   Start Trial PRODUCT NAME: FARMACEUTISK KOMBINATIONSPRODUKT OMFATTENDE ET FARMACEUTISK ACCEPTABELT SALT AF UMECLIDINIUM (F.EKS. UMECLIDINIUMBROMID), VILANTEROL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF (F.EKS. VILANTEROLTRIFENATAT) OG FLUTICASONFUROAT; REG. NO/DATE: EU/1/17/1236 20171117
2506844 132018000000341 Italy   Start Trial PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
1740177 1490060-9 Sweden   Start Trial MARKETING AUTHORIZATION NUMBER AND DATE OF GRANT/NOTIFICATION: EU/1/14/922, 2014-04-30; PERIOD OF VALIDITY (FROM - UNTIL): 20250428 - 20240429
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Harvard Business School
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Boehringer Ingelheim
Merck

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