Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 17, 2019

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TRELEGY ELLIPTA Drug Profile

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

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

This drug has four hundred and eighty-nine patent family members in fifty-one 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.

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

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SponsorPhase
GlaxoSmithKlinePhase 4

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Recent Litigation for TRELEGY ELLIPTA

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District Court Litigation
Case NameDate
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2015-09-08
GlaxoSmithKline Intellectual Property Management Limited v. Sandoz Inc.

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Synonyms for TRELEGY ELLIPTA
FF/UMEC/VI
Fluticasone furoate mixture with umeclidinium and vilanterol
Fluticasone furoate, umeclidinium and vilanterol
S900007500

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 209482-001 Sep 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 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
1740177 CA 2014 00052 Denmark   Start Trial PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
1305329 300343 Netherlands   Start Trial 300343, 20210803, EXPIRES: 20230110
1425001 CA 2014 00021 Denmark   Start Trial PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113
1425001 2014C/026 Belgium   Start Trial PRODUCT NAME: VILANTEROL TRIFENATATE; AUTHORISATION NUMBER AND DATE: EU/1/13/886/001 20131114
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 C20180017 00244 Estonia   Start Trial PRODUCT NAME: FLUTIKASOONFUROAAT/UMEKLIDIINIUM/VILANTEROOL;REG NO/DATE: EU/1/17/1236 17.11.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Dow
Boehringer Ingelheim
Harvard Business School
McKinsey
Medtronic

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