Question 1

Is there a generic for Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate?

Accepted Answer

TRELEGY ELLIPTA (NDA 209482, GLAXOSMITHKLINE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate?

Accepted Answer

The Orange Book lists 8 patents against Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate are approved?

Accepted Answer

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate is approved in the following dosage form: powder.

Patent	Expires	In	Type
7488827	Dec 18, 2027	in 1 yr 6 mo	SubstanceProduct
8534281	Mar 08, 2030	in 3 yr 9 mo	Product
8534281*PED	Sep 08, 2030	in 4 yr 3 mo
8746242	Oct 11, 2030	in 4 yr 5 mo	Product
11090294	Nov 29, 2030	in 4 yr 6 mo	U-3202
9750726	Nov 29, 2030	in 4 yr 6 mo	Product
12396986	Nov 29, 2030	in 4 yr 6 mo	Product
8746242*PED	Apr 11, 2031	in 4 yr 11 mo

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

Brand (NDA) products · powder

Listed patents (8)

Fluticasone furoate; umeclidinium bromide; vilanterol trifenatate — frequently asked questions

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