AZELASTINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for azelastine hydrochloride and what is the scope of freedom to operate?

Azelastine hydrochloride is the generic ingredient in ten branded drugs marketed by Alembic, Apotex, Epic Pharma Llc, Gland, Sandoz, Somerset Theraps Llc, Sun Pharm, Rising, Viatris, Bayer Hlthcare, Alkem Labs Ltd, Amneal, Apotex Inc, Aurobindo Pharma Ltd, Bionpharma, Hikma, Padagis Israel, Padagis Us, Sciegen Pharms Inc, Zydus Pharms, Aurobindo Pharma, Teva Pharms Usa Inc, and Mylan Speciality Lp, and is included in thirty-five NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azelastine hydrochloride has fifty patent family members in twenty-four countries.

There are nine drug master file entries for azelastine hydrochloride. Twenty-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for AZELASTINE HYDROCHLORIDE

International Patents:	50
US Patents:	4
Tradenames:	10
Applicants:	23
NDAs:	35
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	50
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AZELASTINE HYDROCHLORIDE
What excipients (inactive ingredients) are in AZELASTINE HYDROCHLORIDE?	AZELASTINE HYDROCHLORIDE excipients list
DailyMed Link:	AZELASTINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for AZELASTINE HYDROCHLORIDE

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

Sponsor	Phase
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.	PHASE2
Xu Yu	NA
MEDA Pharma GmbH & Co. KG	Phase 2

See all AZELASTINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for AZELASTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		0.2055MG/SPRAY	SPRAY, METERED;NASAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for AZELASTINE HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for AZELASTINE HYDROCHLORIDE

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CHILDREN'S ASTEPRO ALLERGY	Nasal Spray	azelastine hydrochloride	205.5 mcg/spray	213872	1	2021-07-12
ASTEPRO	Nasal Spray	azelastine hydrochloride	205.5 mcg/spray	022203		2011-12-15
OPTIVAR	Ophthalmic Solution	azelastine hydrochloride	0.05%	021127	1	2006-12-13
ASTELIN	Nasal Spray	azelastine hydrochloride	0.125 mg base/spray	020114	1	2005-11-14

US Patents and Regulatory Information for AZELASTINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009		DISCN	No	No			Y
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes
Aurobindo Pharma Ltd	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SPRAY, METERED;NASAL	212289-001	May 8, 2020	AB	RX	No	No
Viatris	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-001	Oct 15, 2008		DISCN	Yes	No			Y
Bionpharma	AZELASTINE HYDROCHLORIDE	azelastine hydrochloride	SPRAY, METERED;NASAL	090176-001	Jul 28, 2015		DISCN	No	No

Expired US Patents for AZELASTINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	OPTIVAR	azelastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021127-001	May 22, 2000
Bayer Hlthcare	CHILDREN'S ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-002	Jun 17, 2021
Bayer Hlthcare	CHILDREN'S ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-002	Jun 17, 2021
Viatris	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009
Viatris	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009

International Patents for AZELASTINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007061454
Denmark	2377557
Slovenia	2522365
Denmark	2522365
Portugal	2377557

Supplementary Protection Certificates for AZELASTINE HYDROCHLORIDE

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

Market Dynamics and Financial Trajectory for Azelastine Hydrochloride

Last updated: July 27, 2025

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Introduction

Azelastine hydrochloride, a potent antihistamine primarily used in allergy management, has established its presence within the pharmaceutical landscape. Its versatility in topical nasal sprays and ophthalmic formulations has driven consistent demand, positioning it as a critical component in allergy therapeutics. Analyzing the evolving market dynamics and projected financial trajectories provides critical insights for stakeholders—including pharmaceutical manufacturers, investors, and healthcare policymakers—seeking to navigate this segment's future.

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Market Overview

Azelastine hydrochloride is marketed predominantly as a nasal spray (e.g., Astelin, Optivar) for allergic rhinitis and conjunctivitis, and in some regions, as a cream or gel formulary for dermatological applications. The drug has benefitted from increasing allergy prevalence globally, driven by environmental factors, urbanization, and climate change, with respiratory allergies affecting approximately 10-30% of the global population [1].

The global allergy therapeutics market, valued at around USD 20 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 6-8% through 2030. Azelastine hydrochloride, capturing a significant share, benefits from this upward trend fueled by aging populations, rising allergy awareness, and advancements in drug delivery systems.

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Competitive Landscape

The key players in the azelastine segment include AstraZeneca, Santen Pharmaceutical, and Teva Pharmaceutical Industries. AstraZeneca's nasal spray product remains a dominant market presence, supported by robust marketing channels and research investments. The competitive landscape emphasizes innovation in formulation, patient compliance, and repurposing opportunities, driving the continuous evolution of azelastine-based products.

Genericization poses both challenges and opportunities. The patent expiry of branded formulations, such as AstraZeneca's patent protections, has precipitated a notable rise in generic entries. This introduces price competition but also expands market penetration, particularly in markets with limited healthcare expenditure.

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Market Drivers and Restraints

Drivers:

• Rising Allergic Conditions: Increased prevalence due to environmental pollutants augments demand.
• Patient Preference: Non-sedating antihistamines, such as azelastine, meet patient demand for effective, minimal side-effect treatments.
• Regulatory Approvals and Innovation: Expanding indications and combination therapies enhance market reach.
• Growing Global Middle Class: Increased access to healthcare and pharmaceuticals fuel adoption in emerging markets.

Restraints:

• Generic Competition and Price Erosion: Widespread patent expirations result in aggressive pricing strategies.
• Limited Differentiation: The availability of multiple antihistamines limits market differentiation.
• Regulatory Hurdles: Stringent regulations in different jurisdictions complicate registration and commercialization.

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Financial Trajectory and Forecasts

The financial outlook for azelastine hydrochloride hinges on product pipeline developments, patent landscapes, and market expansion strategies. Current estimates project the following:

• Revenue Growth: The global market for azelastine in nasal spray formulations is expected to grow from approximately USD 1.2 billion in 2022 to over USD 2 billion by 2030, representing a CAGR of around 7% [2]. This growth rate aligns with the broader allergy therapeutics market.

• Profitability Trends: Innovator companies will continue to command higher margins through brand loyalty, whereas generics will drive volume growth but with reduced margins. Price erosion due to generics is anticipated to moderate profit margins by approximately 10-15% over the next five years in mature markets.

• Market Penetration in Emerging Economies: Countries such as China, India, and Brazil are forecast to see a compounded growth rate exceeding 10%, attributable to increasing allergy prevalence, increased healthcare infrastructure, and rising consumer awareness.

• Formulation Innovation: Investments in sustained-release nasal sprays or combination therapies (e.g., azelastine with corticosteroids) are expected to generate incremental revenues, creating new market segments.

• Impact of Patent Expiration: The 2020s mark a pivotal period with several patents expiring, accelerating generic competition. However, new formulations and delivery devices may sustain revenues for trailblazing companies.

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Regulatory and Market Entry Considerations

Regulatory pathways, especially in the U.S. and European Union, are critical for revenue security. Recent approvals for azelastine nasal spray in pediatric populations and for over-the-counter (OTC) status in some regions herald new revenue avenues.

Market entry into developing nations requires navigating complex regulatory environments, localized manufacturing, and distribution partnerships. Tailoring formulations to regional preferences and cost structures will be essential for growth.

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Innovation and Future Opportunities

• Combination Therapies: Co-formulations with corticosteroids or other antihistamines can improve efficacy and patient adherence, opening premium pricing models.
• Delivery Technologies: Novel delivery devices—such as personalized nasal sprays or smart delivery systems—could enhance user experience, supporting premium pricing and market differentiation.
• Expanding Indications: Investigating azelastine's role in atopic dermatitis, asthma, or other allergic conditions may open new revenue streams.

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Risks and Uncertainties

• Market Saturation: Patent expirations and generic competition threaten revenue streams.
• Regulatory Challenges: Delays or failures in approval processes can impact financial performance.
• Market Acceptance: Preference for newer therapies and consumer reluctance to switch may slow growth.

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Key Takeaways

• The azelastine hydrochloride market is poised for steady growth aligned with the global allergy therapeutics industry, driven by rising allergy prevalence and innovation in drug delivery.
• Patent expirations and generic entry will exert downward pressure on prices but simultaneously expand access, especially in emerging markets.
• Innovations in formulation, combination therapies, and device technology are vital to sustaining revenue and competitive advantage.
• Emerging markets represent sizeable growth opportunities due to increasing healthcare access and allergy awareness.
• Strategic investments in R&D, regulatory agility, and market localization will be critical to maximizing financial trajectories.

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FAQs

1. How will patent expirations impact azelastine hydrochloride's market?
Patent expirations lead to increased generic competition, resulting in price reductions and margin compression for branded products. However, they also expand market access through lower consumer prices and increased adoption.

2. What emerging markets offer the most growth potential for azelastine formulations?
Countries in Asia-Pacific, Latin America, and Africa display high growth potential due to rising allergy prevalence, expanding healthcare infrastructure, and increasing consumer purchasing power.

3. Are there new formulation innovations expected to influence the azelastine market?
Yes. Sustained-release nasal sprays, combination therapies, and smart delivery devices are under development, which could enhance efficacy, compliance, and premium pricing.

4. How significant is the role of over-the-counter (OTC) sales for azelastine?
OTC availability in certain regions can substantially increase sales volumes, especially in markets emphasizing self-medication for mild allergy symptoms.

5. What strategies should pharmaceutical companies adopt to retain market share?
Investing in formulation innovation, expanding indications, optimizing supply chains, and establishing strong regulatory and regional partnerships will be key.

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References

[1] Global Allergy and Asthma Network. "Allergic Diseases Facts and Figures," 2021.
[2] MarketWatch. "Global Azelastine Market Size and Forecast," 2022.