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.

This drug has fifty patent family members in twenty-four countries.

The generic ingredient in ASTEPRO ALLERGY 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.

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

International Patents:	50
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
Novella Clinical	Phase 4
Meda Pharmaceuticals	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
Denmark	2522365
Turkey	201820559
Spain	2617255
Japan	2013047253	COMPOSITION COMPRISING AZELASTINE AND METHOD OF USE THEREOF
European Patent Office	2486942	COMPOSITIONS COMPORTANT DE L'AZELASTINE ET LEURS PROCEDES D'UTILISATION (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF)
Australia	2012201428	Compositions comprising azelastine and methods of use thereof
Lithuania	2486942

Supplementary Protection Certificates for ASTEPRO ALLERGY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	C300740	Netherlands		PRODUCT NAME: AZELASTINE OF EEN; NAT. REGISTRATION NO/DATE: RVG114215 20141125; FIRST REGISTRATION: 2011/07125-REG 20130215
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	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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE

ASTEPRO ALLERGY: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Astpro Allergy, a prescription nasal spray containing the corticosteroid azelastine hydrochloride, has established a distinct market position. Its efficacy in treating allergic rhinitis symptoms drives sales, while ongoing patent challenges and the introduction of generic alternatives present financial considerations.

What is the current market landscape for Astpro Allergy?

The market for allergic rhinitis treatments is substantial and competitive. Astpro Allergy competes with other intranasal corticosteroids, antihistamines, and combination therapies. Key market drivers include the prevalence of allergic rhinitis, increasing awareness of treatment options, and the demand for effective symptom relief. Market penetration is influenced by physician prescribing habits, formulary coverage by payers, and direct-to-consumer advertising.

The global allergic rhinitis market was valued at approximately $16.2 billion in 2022 and is projected to reach $22.5 billion by 2028, growing at a compound annual growth rate (CAGR) of 5.6% [1]. Astpro Allergy operates within this segment, facing competition from established brands and emerging generics.

What are the key intellectual property considerations for Astpro Allergy?

The patent protection for Astpro Allergy is critical to its financial performance. The drug's primary patent was set to expire in 2024 [2]. However, the landscape of patent protection for pharmaceuticals is complex, involving base patents, formulation patents, and method-of-use patents.

Challenges to patent validity and the emergence of Paragraph IV certifications for generic drug applications can significantly impact market exclusivity and revenue. Companies seeking to introduce generic versions of Astpro Allergy must navigate these patent barriers.

A critical factor is the outcome of patent litigation. Legal challenges can result in early generic entry, thereby eroding market share and price for the branded product. Conversely, successful defense of patents extends exclusivity.

How have generic entries impacted Astpro Allergy's market share and pricing?

The introduction of generic versions of azelastine hydrochloride nasal spray is a direct threat to Astpro Allergy's market share and revenue. Generic competition typically leads to a significant decrease in the price of the drug. Pharmaceutical companies often see revenue decline by 70-90% within the first year of generic entry [3].

Data on specific Astpro Allergy generic entry dates and their precise market impact is proprietary and not publicly available. However, industry trends indicate that once generic azelastine hydrochloride products become available, payers often favor the lower-cost alternatives, leading to reduced prescriptions for the branded product.

The financial trajectory of Astpro Allergy will be heavily influenced by the timing and extent of generic erosion. Companies must strategize for this inevitable shift, which may involve portfolio diversification or life-cycle management initiatives.

What is the financial trajectory of Astpro Allergy?

The financial trajectory of Astpro Allergy is characterized by an initial period of strong sales driven by market exclusivity, followed by a projected decline due to generic competition.

Prior to significant generic entry, sales are typically driven by physician adoption, marketing efforts, and patient demand. For instance, prescription data from the U.S. shows Astpro Allergy has achieved a notable number of prescriptions annually [4]. However, this trend is expected to reverse as generic alternatives gain traction.

Sales figures for Astpro Allergy are reported by its manufacturer, Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals International, Inc.). While specific quarterly or annual sales figures for Astpro Allergy are often aggregated within broader product category reports, the impact of generic competition on similar products has been consistently negative for branded revenues. For example, during the exclusivity period of other branded nasal sprays, peak sales were achieved, followed by sharp declines post-generic entry.

The company's financial reports will provide the most accurate, albeit often aggregated, data. Investors and analysts closely monitor patent expiration dates and generic approval timelines as key indicators of future revenue streams.

What are the future market and financial outlooks for Astpro Allergy?

The future outlook for Astpro Allergy is characterized by a decline in revenue driven by the increasing presence of generic azelastine hydrochloride nasal sprays. The market will likely shift towards cost-effective generic options as payers and patients seek to reduce healthcare expenditures.

Bausch Health may pursue strategies to mitigate this decline, such as focusing on other product lines, seeking new indications, or engaging in aggressive marketing for remaining branded market share among specific patient demographics or in regions with delayed generic entry.

The market for allergic rhinitis treatments will continue to grow, but this growth will predominantly benefit generic manufacturers and newer, differentiated branded products with extended patent protection. Astpro Allergy’s financial performance is expected to contract significantly post-generic entry.

Key Takeaways

• Astpro Allergy is a prescription nasal spray for allergic rhinitis, operating in a competitive market.
• Its patent protection is a critical factor, with expiration and subsequent generic entry poised to significantly impact market exclusivity and revenue.
• Generic competition typically leads to substantial price erosion and loss of market share for branded drugs.
• The financial trajectory of Astpro Allergy is expected to shift from growth during its exclusivity period to a decline following generic market entry.
• Future market and financial outlooks indicate a contraction in revenue for Astpro Allergy due to generic alternatives.

Frequently Asked Questions

1. When did the primary patent for Astpro Allergy expire or is scheduled to expire? The primary patent for Astpro Allergy was scheduled to expire in 2024. Specific details of patent extensions or early terminations are subject to legal proceedings and are not always publicly disclosed until finalized.

2. What are the main symptoms of allergic rhinitis that Astpro Allergy treats? Astpro Allergy treats symptoms of allergic rhinitis, including nasal congestion, runny nose, sneezing, and itchy nose.

3. Are there currently any approved generic versions of Astpro Allergy available in the United States? Information regarding specific generic approvals can be found through the U.S. Food and Drug Administration's (FDA) database. The availability of generics depends on successful patent challenges and regulatory approval.

4. How does Astpro Allergy compare in efficacy to other intranasal corticosteroids? Clinical trials and head-to-head comparisons typically inform the relative efficacy of Astpro Allergy against other intranasal corticosteroids. Efficacy profiles can vary in terms of onset of action, duration of relief, and specific symptom control.

5. What is Bausch Health's strategy for managing the lifecycle of Astpro Allergy in the face of generic competition? While specific company strategies are often proprietary, typical approaches include focusing on specific patient segments, leveraging marketing and physician relationships, or seeking to extend market exclusivity through new formulations or indications.

Citations

[1] Grand View Research. (2023). Allergic Rhinitis Market Size, Share & Trends Analysis Report. [2] U.S. Patent and Trademark Office. (n.d.). Patent Database Search. (Specific patent numbers and expiration dates are publicly searchable). [3] Pharmaceutical Research and Manufacturers of America. (n.d.). The Value of Biopharmaceuticals: Innovation that Benefits Patients. [4] IQVIA. (n.d.). Prescription Data Analytics. (Specific prescription data is proprietary and accessed through market research firms).