ASTELIN Drug Patent Profile

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

Astelin is a drug marketed by Norvium Bioscience 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-one 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:	114
Clinical Trials:	6
Patent Applications:	1,732
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
Prolytic GmbH	Phase 1
ClinResearch, GmbH	Phase 1
MEDA Pharma GmbH & Co. KG	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
Norvium Bioscience	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
Norvium Bioscience	ASTELIN	azelastine hydrochloride	SPRAY, METERED;NASAL	020114-001	Nov 1, 1996

International Patents for ASTELIN

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P920668	PREPARATIONS CONTAINING AZELASTINE FOR APPLICATION IN THE NOSE AND/OR TO THE EYE
Canada	1319322	MEDICAMENTS CONTENANT DE L'AZELASTINE POUR APPLICATION DANS LE NEX OU DANS LES YEUX (AZELASTINE-CONTAINING MEDICAMENTS FOR APPLICATION IN THE NOSE AND/OR EYE)
Japan	H01153639	DRUG USED IN NOSE OR EYE AND ITS PRODUCTION
Greece	3007202
Japan	2911460
Germany	3836579

Supplementary Protection Certificates for ASTELIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

ASTELIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Azelastine (ASTELIN)

Introduction to Azelastine (ASTELIN)

Azelastine, marketed under the brand name ASTELIN among others, is a potent antihistamine used to treat allergic rhinitis and conjunctivitis. The drug is available in various forms, including nasal sprays and eye drops, making it a versatile treatment option for patients suffering from allergy symptoms.

Global Market Size and Forecast

The global azelastine market is poised for significant growth. As of 2024, the market size is estimated to be USD 1152.2 million, with a projected compound annual growth rate (CAGR) of 6.20% from 2024 to 2031. This growth is expected to drive the market size to USD 1755.49 million by 2031[4].

Key Drivers of Market Growth

Increasing Prevalence of Allergic Disorders

The rising prevalence of allergic conditions such as allergic rhinitis and conjunctivitis is a major driver of the azelastine market. Environmental factors like air pollution and climate change have increased pollen levels, leading to more frequent and severe allergy symptoms. This has resulted in a higher demand for effective antihistamines like azelastine[4].

Growing Awareness and Healthcare Expenditure

In regions like the Asia Pacific, growing awareness of allergic diseases and increased healthcare expenditure are contributing to the market's expansion. As healthcare systems focus more on preventive care and symptom management, the demand for azelastine is expected to rise[1].

Aging Population

The aging population, which is more susceptible to allergies due to weakened immune responses, is another significant factor driving the market. Older adults are more likely to seek medical treatment for allergic symptoms, thereby increasing the demand for azelastine[4].

Regional Market Dynamics

North America

North America holds a major share of the global azelastine market, with a market size of USD 460.88 million in 2024. The region is expected to grow at a CAGR of 4.4% from 2024 to 2031. The strong regulatory network in the United States and Canada ensures that pharmaceuticals meet high safety, efficacy, and quality standards, which boosts confidence in azelastine among healthcare practitioners and patients[4].

Europe

Europe accounts for more than 30% of the global revenue, with a market size of USD 345.66 million in 2024. The European market is forecasted to grow at a CAGR of 4.7% from 2024 to 2031. Countries like the United Kingdom, France, and Germany are key contributors to this growth, driven by increasing allergy prevalence and healthcare spending[4].

Asia Pacific

The Asia Pacific region holds around 23% of the global revenue, with a market size of USD 265.01 million in 2024. This region is expected to grow at a CAGR of 8.2% from 2024 to 2031, driven by growing awareness of allergic diseases, urbanization, and environmental pollution[4].

Competitive Landscape

The azelastine market is highly competitive, with several established and emerging pharmaceutical companies. Key players include Apotex, Breckenridge, Sun Pharma, Hikma Pharmaceuticals, Perrigo, Amneal Pharmaceuticals, Alkem Labs, Mylan, and Teva. These companies compete based on product innovation, pricing strategies, distribution networks, and marketing activities. Partnerships, collaborations, and acquisitions are common strategies to enhance market position and expand product offerings[1].

Advances in Medication Delivery

Advances in medication delivery methods, such as the development of nasal sprays and eye drops, have increased the accessibility and convenience of azelastine for patients. These formulations have improved patient compliance and satisfaction, further driving the market growth[1].

Financial Trajectory

Revenue Growth

The global azelastine market is expected to see significant revenue growth from 2024 to 2031. With a CAGR of 6.20%, the market is projected to reach USD 1755.49 million by 2031. This growth is driven by increasing demand for effective treatments for allergic disorders and the expanding senior population[4].

Regional Revenue Breakdown

• North America: USD 460.88 million in 2024, growing at a CAGR of 4.4% to 2031.
• Europe: USD 345.66 million in 2024, growing at a CAGR of 4.7% to 2031.
• Asia Pacific: USD 265.01 million in 2024, growing at a CAGR of 8.2% to 2031.
• Latin America: USD 57.61 million in 2024, growing at a CAGR of 5.6% to 2031.
• Middle East and Africa: USD 23.04 million in 2024, growing at a CAGR of 5.9% to 2031[4].

Regulatory Impact

A strong regulatory network, particularly in North America, plays a crucial role in driving the azelastine market. Regulatory bodies like the FDA and Health Canada ensure that pharmaceuticals meet stringent safety, efficacy, and quality standards, which enhances trust among healthcare practitioners and patients. This regulatory approval opens up substantial market opportunities in regions with high frequencies of allergic diseases[1].

Key Takeaways

• The global azelastine market is expected to grow significantly from 2024 to 2031, driven by the increasing prevalence of allergic disorders.
• North America, Europe, and the Asia Pacific are key regions contributing to the market growth.
• Advances in medication delivery methods and a strong regulatory framework are crucial factors driving the market.
• The competitive landscape is characterized by established and emerging pharmaceutical companies competing on various fronts.

FAQs

What is the current market size of the global azelastine market?

The global azelastine market size is estimated to be USD 1152.2 million in 2024[4].

What is the projected CAGR for the global azelastine market from 2024 to 2031?

The global azelastine market is expected to grow at a CAGR of 6.20% from 2024 to 2031[4].

Which region holds the largest market share in the global azelastine market?

North America holds the largest market share, with a market size of USD 460.88 million in 2024[4].

What are the key drivers of the azelastine market growth?

Key drivers include the increasing prevalence of allergic disorders, growing awareness and healthcare expenditure, and an aging population[1][4].

Who are some of the prominent players in the azelastine market?

Prominent players include Apotex, Breckenridge, Sun Pharma, Hikma Pharmaceuticals, Perrigo, Amneal Pharmaceuticals, Alkem Labs, Mylan, and Teva[1].

Sources

1. Verified Market Research: In-Depth Industry Outlook: Azelastine Market Size & Forecast.
2. Astellas Pharma Inc.: Financial Results of Astellas for Fiscal Year 2023.
3. Wicz.com: Global Azelastine Nasal Spray Market [2024] | The Future of Industry by 2032.
4. Cognitive Market Research: Azelastine Market Report 2024.
5. Simply Wall St: Astellas Pharma Inc. (TSE:4503) Just Released Its Half-Yearly Earnings: Here’s What Analysts Are Forecasting For 2025.