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Generated: May 24, 2019

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Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate - Generic Drug Details

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What are the generic sources for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate and what is the scope of fluticasone furoate; umeclidinium bromide; vilanterol trifenatate freedom to operate?

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate has four hundred and eighty-five patent family members in fifty-one countries.

There are twenty-nine drug master file entries for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. One supplier is listed for this compound.

Pharmacology for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

US Patents and Regulatory Information for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 122018000060 Germany ➤ Sign Up PRODUCT NAME: PHARMAZEUTISCHES KOMBINATIONSPRODUKT UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMCELIDINIUM (Z.B. UMECLIDINIUMBROMID), VILANTEROL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B. VILANTEROLTRIFENATAT) UND FLUTICASONFUROAT.; REGISTRATION NO/DATE: EU/1/17/1236 20171115
1425001 PA2014019 Lithuania ➤ Sign Up PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
1425001 C20140013 00103 Estonia ➤ Sign Up PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013
2506844 C201830030 Spain ➤ Sign Up PRODUCT NAME: UN PRODUCTO FARMACEUTICO QUE COMPRENDE LA COMBINACION DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DE UMECLIDINIO (P.EJ. BROMURO DE UMECLIDINIO), VILANTEROL O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO (P.EJ. TRIFENATATO DE VILANTEROL) Y FUROATO DE FLUTICASONA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1236; DATE OF AUTHORISATION: 20171115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1236; DATE OF FIRST AUTHORISATION IN EEA: 20171115
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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