ASTEPRO Drug Patent Profile

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

Astepro is a drug marketed by Norvium Bioscience and Bayer Hlthcare and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ASTEPRO is azelastine hydrochloride. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Astepro

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

Summary for ASTEPRO

International Patents:	50
US Patents:	3
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	5
Patent Applications:	1,732
Drug Prices:	Drug price information for ASTEPRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASTEPRO
DailyMed Link:	ASTEPRO at DailyMed

See drug prices for ASTEPRO

See drug sales revenues for ASTEPRO

Recent Clinical Trials for ASTEPRO

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 clinical trials

Paragraph IV (Patent) Challenges for ASTEPRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ASTEPRO	Nasal Spray	azelastine hydrochloride	205.5 mcg/spray	022203		2011-12-15

US Patents and Regulatory Information for ASTEPRO

ASTEPRO is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-001	Oct 15, 2008		DISCN	Yes	No
Norvium Bioscience	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-001	Oct 15, 2008		DISCN	Yes	No			Y
Norvium Bioscience	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009		DISCN	No	No			Y
Norvium Bioscience	ASTEPRO	azelastine hydrochloride	SPRAY, METERED;NASAL	022203-002	Aug 31, 2009		DISCN	No	No
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes			Y
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes			Y
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes

International Patents for ASTEPRO

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

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0517891	composições compreendendo azelastina e métodos de uso das mesmas
Denmark	2377557
Hungary	E031470
Lithuania	2486942
Portugal	2486942
Spain	2617255
World Intellectual Property Organization (WIPO)	2007061454

Supplementary Protection Certificates for ASTEPRO

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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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

Azelastine Market Dynamics and Financial Trajectory: A Deep Dive into ASTEPRO

Introduction

Azelastine, marketed under the brand name ASTEPRO among others, is a potent antihistamine used primarily to treat allergic rhinitis and conjunctivitis. The global azelastine market is experiencing significant growth, driven by several key factors. Here, we will explore the market dynamics, financial trajectory, and regional insights that shape the future of azelastine.

Growing Prevalence of Allergic Conditions

The increasing prevalence of allergic conditions such as rhinitis and conjunctivitis is a primary driver of the azelastine market. Environmental factors like rising air pollution and climate change have led to higher pollen levels, resulting in more frequent and severe allergy symptoms. This trend is expected to continue, fueling the demand for effective antihistamines like azelastine[1][4].

Market Size and Revenue

As of 2024, the global azelastine market size is estimated to be USD 1152.2 million. This figure is projected to grow at a compound annual growth rate (CAGR) of 6.2% from 2024 to 2031. This growth indicates a robust market with substantial future potential[1].

Regional Market Analysis

North America

North America holds the largest market share, accounting for more than 40% of the global revenue 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 United States is the dominant player in this region, with a market size of USD 363.63 million and a CAGR of 4.2%[1].

Europe

Europe accounts for over 30% of the global revenue, with a market size of USD 345.66 million in 2024. The region is anticipated 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 market[1].

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 significant CAGR of 8.2% from 2024 to 2031, driven by increasing healthcare expenditure, rising prevalence of chronic diseases, and improved healthcare access[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global market, albeit with smaller shares. Latin America accounts for around 5% of the global revenue with a market size of USD 57.61 million and a CAGR of 5.6%, while the Middle East & Africa account for around 2% with a market size of USD 23.04 million and a CAGR of 5.9%[1].

Regulatory Environment

A strong regulatory network, particularly in North America, plays a crucial role in driving the azelastine market. Regulatory bodies such as the FDA and Health Canada ensure that pharmaceuticals meet high safety, efficacy, and quality standards. This regulatory approval enhances the credibility and reliability of azelastine, making it a preferred treatment option for healthcare practitioners and patients[4].

Advances in Medication Delivery

Advances in medication delivery methods, such as the development of nasal sprays and eye drops containing azelastine, have increased the accessibility and convenience of the drug. These formulations make it easier for patients to manage their allergy symptoms effectively, contributing to the market's growth[4].

Impact of Aging Population

The growing senior population is more susceptible to allergic conditions due to weakened immune responses. This demographic shift further fuels the demand for azelastine, as older adults seek effective treatments for their allergy symptoms[1][4].

Financial Performance and Projections

The financial performance of the azelastine market is robust, with significant revenue growth projected over the next few years. Here are some key financial metrics:

• Global Revenue: USD 1152.2 million in 2024, growing at a CAGR of 6.2% from 2024 to 2031.
• North America: USD 460.88 million in 2024, growing at a CAGR of 4.4%.
• Europe: USD 345.66 million in 2024, growing at a CAGR of 4.7%.
• Asia Pacific: USD 265.01 million in 2024, growing at a CAGR of 8.2%[1].

Industry Expert Insights

Industry experts highlight the importance of regulatory approval and the growing awareness of azelastine’s efficacy in treating allergy symptoms.

"The presence of a strong regulatory network in North America guarantees that pharmaceuticals like azelastine satisfy high safety, efficacy, and quality criteria, giving healthcare practitioners and patients confidence in the therapies’ dependability."[4]

Illustrative Statistics

• Global Market Size: USD 1152.2 million in 2024.
• North America Market Share: Over 40% of the global revenue.
• Asia Pacific Growth Rate: 8.2% CAGR from 2024 to 2031.
• Aging Population Impact: The senior population is more susceptible to allergic conditions, driving demand for azelastine[1].

Key Takeaways

• The global azelastine market is driven by the growing prevalence of allergic conditions and environmental factors.
• North America and Europe are the largest markets, with significant growth projected in the Asia Pacific region.
• A strong regulatory environment and advances in medication delivery methods are key drivers.
• The aging population contributes to the increasing demand for azelastine.

FAQs

What is the current global market size for azelastine?

The global azelastine market size is estimated to be USD 1152.2 million in 2024[1].

Which region holds the largest market share for azelastine?

North America holds the largest market share, accounting for more than 40% of the global revenue[1].

What is the projected CAGR for the azelastine market in the Asia Pacific region?

The Asia Pacific region is expected to grow at a CAGR of 8.2% from 2024 to 2031[1].

How does the regulatory environment impact the azelastine market?

A strong regulatory network ensures that azelastine meets high safety, efficacy, and quality standards, enhancing its credibility and reliability among healthcare practitioners and patients[4].

What role does the aging population play in the azelastine market?

The growing senior population, which is more susceptible to allergic conditions, contributes to the increasing demand for azelastine[1][4].

Sources

1. Cognitive Market Research: Azelastine Market Report.
2. Astellas Pharma Inc.: Financial Results of Astellas for Fiscal Year 2023.
3. PR Newswire: Rx-to-OTC Switches Market Sales to surpass US$35bn in 2031.
4. Verified Market Research: Azelastine Market Size & Forecast.