ASTEPRO ALLERGY Drug Patent Profile

Which patents cover Astepro Allergy, and what generic alternatives are available?

Astepro Allergy is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Astepro Allergy

A generic version of ASTEPRO ALLERGY was approved as azelastine hydrochloride by APOTEX INC on April 30^th, 2009.

Summary for ASTEPRO ALLERGY

US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	5
Patent Applications:	1,938
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASTEPRO ALLERGY
What excipients (inactive ingredients) are in ASTEPRO ALLERGY?	ASTEPRO ALLERGY excipients list
DailyMed Link:	ASTEPRO ALLERGY at DailyMed

Recent Clinical Trials for ASTEPRO ALLERGY

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Chicago	Phase 4
Meda Pharmaceuticals	Phase 4
Novella Clinical	Phase 4

See all ASTEPRO ALLERGY clinical trials

Pharmacology for ASTEPRO ALLERGY

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

US Patents and Regulatory Information for ASTEPRO ALLERGY

ASTEPRO ALLERGY is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes	8,071,073		Y

Expired US Patents for ASTEPRO ALLERGY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021	8,518,919
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021	9,919,050

International Patents for ASTEPRO ALLERGY

See the table below for patents covering ASTEPRO ALLERGY around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2005309657	Compositions comprising azelastine and methods of use thereof
Australia	2012201428	Compositions comprising azelastine and methods of use thereof
Australia	2012203343	Compositions comprising azelastine and methods of use thereof
Brazil	PI0517891	composições compreendendo azelastina e métodos de uso das mesmas
Canada	2588338	COMPOSITIONS COMPORTANT DE L'AZELASTINE ET LEURS PROCEDES D'UTILISATION (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF)

Supplementary Protection Certificates for ASTEPRO ALLERGY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0316633	99C0012	Belgium		PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731	C300740	Netherlands		PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215

Last updated: July 21, 2026

ASTEPRO ALLERGY (Astepro) Market Dynamics and Financial Trajectory: Sales Drivers, Share Shifts, Exclusivity and Generic Risk

Executive summary: Astepro Allergy (active ingredient: azelastine hydrochloride) is a long-established intranasal antihistamine with entrenched OTC and prescription demand in allergic rhinitis. Market dynamics center on (1) OTC migration and channel mix, (2) label breadth versus competing intranasal antihistamines (and intranasal corticosteroids), (3) pack-price erosion from generics and private label, and (4) local exclusivity pockets tied to specific dosage strengths/form factors rather than a single blockbuster-style patent moat. Financial trajectory is defined by steady baseline demand with periodic step-downs when additional competitors and formulations gain distribution, plus margin pressure from promotional intensity and retailer-driven pricing.

The analysis below requires specific, citable financial and FDA/Orange Book data for “ASTEPRO ALLERGY” (Astepro) that is not provided in the prompt.