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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 022203

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NDA 022203 describes ASTEPRO, which is a drug marketed by Viatris and Bayer Hlthcare and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ASTEPRO profile page.

The generic ingredient in ASTEPRO is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

Summary for 022203

Tradename:	ASTEPRO
Applicant:	Viatris
Ingredient:	azelastine hydrochloride
Patents:	3

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	0.137MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 15, 2008	TE:		RLD:	Yes
Patent:	8,071,073	Patent Expiration:	Jun 4, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,518,919	Patent Expiration:	Nov 22, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	0.2055MG/SPRAY
Approval Date:	Aug 31, 2009	TE:		RLD:	No
Patent:	8,071,073	Patent Expiration:	Jun 4, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022203

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-001	Oct 15, 2008	8,518,919	⤷ Get Started Free
Viatris	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009	9,919,050	⤷ Get Started Free
Viatris	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009	8,518,919	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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