Question 1

Is there a generic for Fluticasone furoate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Fluticasone furoate. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Fluticasone furoate?

Accepted Answer

ARNUITY ELLIPTA (NDA 205625, 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?

Accepted Answer

The Orange Book lists 3 patents against Fluticasone furoate products, with the earliest listed expiry in 2026. 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

Does Fluticasone furoate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Fluticasone furoate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Fluticasone furoate are approved?

Accepted Answer

Fluticasone furoate is approved in the following dosage forms: powder, spray, metered.

Product	Applicant	Application	TE	Approved
ARNUITY ELLIPTARLD×3	GLAXOSMITHKLINE	NDA 205625	—	May 17, 2018
FLONASE SENSIMIST ALLERGY RELIEFRLD	HALEON US HOLDINGS	NDA 022051	—	Aug 02, 2016

Patent	Expires	In	Type
8062264	Apr 05, 2026	3 mo ago	Product
8347879	Jul 15, 2028	in 2 yr 1 mo	Product
8147461	Oct 15, 2028	in 2 yr 4 mo	Product

Fluticasone furoate

Brand (NDA) products · powder, spray, metered

Marketing exclusivity (1)

Listed patents (3)

Fluticasone furoate — frequently asked questions

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