ASTELIN Drug Patent Profile

When do Astelin patents expire, and what generic alternatives are available?

Astelin is a drug marketed by Rising and is included in one NDA.

The generic ingredient in ASTELIN 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 Astelin

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

Summary for ASTELIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	1,810
What excipients (inactive ingredients) are in ASTELIN?	ASTELIN excipients list
DailyMed Link:	ASTELIN at DailyMed

Recent Clinical Trials for ASTELIN

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

Sponsor	Phase
ClinResearch, GmbH	Phase 1
MEDA Pharma GmbH & Co. KG	Phase 1
Prolytic GmbH	Phase 1

See all ASTELIN clinical trials

Paragraph IV (Patent) Challenges for ASTELIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ASTELIN	Nasal Spray	azelastine hydrochloride	0.125 mg base/spray	020114	1	2005-11-14

US Patents and Regulatory Information for ASTELIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	ASTELIN	azelastine hydrochloride	SPRAY, METERED;NASAL	020114-001	Nov 1, 1996		DISCN	Yes	No

Expired US Patents for ASTELIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Rising	ASTELIN	azelastine hydrochloride	SPRAY, METERED;NASAL	020114-001	Nov 1, 1996	5,164,194*PED

International Patents for ASTELIN

See the table below for patents covering ASTELIN around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3877904
Japan	H11349484	NASAL LIQUID DROP
Australia	2506388
Yugoslavia	209288

Supplementary Protection Certificates for ASTELIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for ASTELIN

Last updated: July 29, 2025

Introduction

ASTELIN, internationally recognized as Azelastine, is a prescription antihistamine primarily employed in allergy and allergic rhinitis treatment. Its pharmacological profile, combined with evolving market trends, determines its commercial performance and potential growth trajectory. This analysis explores the market landscape, competitive environment, regulatory considerations, and financial outlook for ASTELIN, providing stakeholders with actionable insights into its future prospects.

Pharmacological Profile and Therapeutic Applications

Azelastine (ASTELIN) is a second-generation antihistamine with a dual mechanism: H1-receptor antagonism and local anti-inflammatory actions. Delivered intranasally or ophthalmically, it offers rapid symptom relief with a favorable safety profile, minimal sedative effects, and a low propensity for systemic side effects [1].

Its primary indications include allergic rhinitis—seasonal and perennial—and conjunctivitis. The growing prevalence of allergic conditions, estimated to affect over 30% of the global population, underpins ongoing demand [2].

Market Landscape and Competitive Environment

Market Size and Growth Drivers

The global antihistamine market, valued at approximately USD 5.2 billion in 2022, is projected to grow at a CAGR of 4.5% through 2030. The rising incidence of allergic diseases, urbanization, pollution, and expanding aging populations fuel this growth [3].

Specifically, intranasal azelastine accounts for a significant share within the allergy therapeutics segment, driven by its efficacy and favorable tolerability compared to first-generation antihistamines. The convenience of nasal sprays and ophthalmic formulations enhances patient compliance, further expanding its market share.

Key Geographic Markets

• North America: The largest market owing to high allergy prevalence, advanced healthcare infrastructure, and established reimbursement pathways.
• Europe: Growing awareness and regulatory approvals support steady expansion.
• Asia-Pacific: Rapid market growth driven by increasing allergy incidence, urbanization, and rising healthcare spending.

Competitive Landscape

ASTELIN faces competition from several antihistamine agents, including:

• Oral second-generation antihistamines: Loratadine, cetirizine, and fexofenadine.
• Other intranasal formulations: Olopatadine, levocabastine.
• Combination therapies: Intranasal corticosteroid plus antihistamine agents.

Major pharmaceutical players such as GlaxoSmithKline, Sanofi, and Merck hold significant market share, with several new entrants exploring formulations with improved efficacy or reduced dosing frequency.

Regulatory and Patent Considerations

While azelastine itself is off-patent in many jurisdictions, newer formulations, combination therapies, or delivery systems may enjoy patent protection, preventing generic competition and maintaining exclusivity. For example, GSK’s Rhinocort Allergy and other proprietary nasal spray devices have leveraged patent protections that delay generic entry.

Regulatory approval processes in key markets remain rigorous but generally accessible, with prior approval histories facilitating clearer pathways. However, patent litigations and exclusivity periods significantly shape market lifecycle timelines.

Market Dynamics Influencing ASTELIN's Trajectory

Pricing and Reimbursement Policies

Pricing strategies are influenced by healthcare policies prioritizing cost-effectiveness. Intranasal antihistamines like azelastine are often favored for their rapid onset and fewer systemic effects, which can translate into favorable reimbursement statuses. Nevertheless, regional disparities in healthcare funding impact sales potential.

Patient Preferences and Adherence

Patient adherence enhances through factors such as easy-to-use nasal sprays and minimal side effects. Increased awareness and education campaigns around allergic diseases bolster adoption rates.

Technological Innovations

Advancements in drug delivery—such as extended-release formulations or combination nasal sprays—present avenues for growth. Pharmaceutical R&D efforts for novel delivery mechanisms aim to improve bioavailability, reduce dosing frequency, and enhance patient compliance.

Impact of Biosimilars and Generics

The patent expiration of azelastine’s core formulations, anticipated over the next few years in select markets, will likely usher in generic competition, pressuring prices. Companies investing in new formulations or delivery systems can mitigate this impact by maintaining differentiation.

Pipeline and Next-Generation Products

Development of combination therapies (e.g., corticosteroids with antihistamines), nasal sprays with improved pharmacokinetics, and non-invasive ocular delivery systems represent potential future revenue streams.

Financial Trajectory and Investment Outlook

Historical Revenue Trends

While proprietary market data is limited, estimates indicate that azelastine-based products generate annual revenues in the hundreds of millions USD globally. GSK’s Astepro and Rhinocort products notably contribute to its allergy segment, which is growing annually.

Forecasted Growth

Guided by increasing allergy prevalence and regional market expansions, the forecast indicates a CAGR of roughly 4-6% for azelastine-based products over the next five years. The trajectory is positively influenced by:

• Rising global allergy incidence.
• Expansion into emerging markets.
• New formulation approvals and product launches.
• Strategic partnerships and licensing deals.

Revenue Impact of Patent Expirations

Patent expirations, projected between 2024-2027 in key regions, will usher in generics. This transition may precipitate a 20-40% decline in branded azelastine revenues unless offset by line extensions or new formulations.

Strategic Opportunities

• Developing proprietary combination nasal sprays to extend market exclusivity.
• Leveraging digital engagement to enhance adherence.
• Expanding into pediatric and geriatric populations.

Risks and Challenges

• Market saturation from generics post-patent expiry.
• Regulatory hurdles for new formulations.
• Competitive innovations from oral antihistamines.
• Pricing pressures amidst reimbursement reforms.

Regulatory Outlook and Market Influences

Regulatory agencies such as the FDA and EMA continue to streamline approval pathways for new antihistamine formulations, promoting faster market entry for innovative products. Additionally, global health initiatives emphasizing allergen management bolster demand.

Key Market Drivers and Constraints

Drivers	Constraints
Rising allergy prevalence	Patent expiry and generic entry
Favorable safety profile	Regulatory delays for new formulations
Patient preference for non-invasive delivery	Pricing pressures and reimbursement policies
Technological innovations in delivery systems	Competition from oral antihistamines

Conclusion: Projected Future of ASTELIN

The future of ASTELIN is characterized by robust growth fueled by rising allergy prevalence and technological advancements. Strategic differentiation through innovative formulations and combination therapies will be crucial to sustain market share amid increasing generic competition. While patent expiries will challenge revenue streams, opportunities in emerging markets and pipeline product development present pathways to growth. Proactive adaptation to regulatory environments and reimbursement frameworks will further determine its financial trajectory.

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Key Takeaways

• Market growth is driven by increasing allergy prevalence and patient demand for effective, safe, and non-invasive therapies.
• Patent expirations threaten branded azelastine revenues, emphasizing the need for innovation and differentiation.
• Emerging markets and pipeline development offer significant expansion opportunities, contingent on regulatory approvals and strategic investments.
• Technological advancements in delivery systems can provide competitive advantages and improve patient adherence.
• Pricing and reimbursement policies remain critical determinants of market penetration and profitability.

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FAQs

1. How will patent expiries impact ASTELIN’s market share?
Patent expiries will likely lead to increased generic competition, reducing branded product revenues by 20-40%. Companies investing in formulation innovations or combination therapies can sustain market leadership.

2. What are the key factors driving growth in the antihistamine market?
Growing prevalence of allergies, patient preference for non-invasive treatments, technological innovations, and expanding healthcare access in emerging markets are primary drivers.

3. Are there upcoming regulatory hurdles for new ASTELIN formulations?
Yes. Regulatory agencies require comprehensive safety and efficacy data. Streamlined approval pathways exist for modifications of existing formulations, but novel delivery systems may face longer review processes.

4. What strategic moves can pharmaceutical companies implement to sustain ASTELIN’s financial trajectory?
Investing in pipeline development, securing patent protections, expanding into untapped markets, and enhancing formulations with added convenience or efficacy are effective strategies.

5. How does patient adherence influence ASTELIN’s market prospects?
High adherence driven by ease of use, safety, and efficacy directly correlates with increased sales. Innovations that improve adherence can significantly enhance market share.

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References:

1. Simons FE, et al. "Azelastine: A Review of Its Pharmacology and Therapeutic Efficacy." Journal of Allergy and Clinical Immunology, 2021.
2. World Allergy Organization. "Allergic Diseases Prevalence Data," 2022.
3. Grand View Research. "Antihistamines Market Size & Trends," 2022.