Question 1

Is there a generic for Azelastine hydrochloride; fluticasone propionate?

Accepted Answer

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Azelastine hydrochloride; fluticasone propionate, referencing the brand DYMISTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Azelastine hydrochloride; fluticasone propionate?

Accepted Answer

DYMISTA (NDA 202236, MYLAN SPECIALITY LP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Azelastine hydrochloride; fluticasone propionate?

Accepted Answer

The Orange Book lists 2 patents against Azelastine hydrochloride; fluticasone propionate 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

What dosage forms of Azelastine hydrochloride; fluticasone propionate are approved?

Accepted Answer

Azelastine hydrochloride; fluticasone propionate is approved in the following dosage form: spray, metered.

Product	Applicant	Application	TE	Approved
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	TEVA PHARMS USA INC	ANDA 208436	AB	Apr 08, 2025
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	PADAGIS ISRAEL	ANDA 208111	AB	Feb 18, 2021
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	APOTEX	ANDA 207712	AB	Apr 28, 2017

Patent	Expires	In	Type
8168620	Feb 24, 2026	4 mo ago	Product
8168620*PED	Aug 24, 2026	in 2 mo

Azelastine hydrochloride; fluticasone propionate

Brand (NDA) products · spray, metered

Generic (ANDA) products (3)

Listed patents (2)

Azelastine hydrochloride; fluticasone propionate — frequently asked questions

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