You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

AZELASTINE HYDROCHLORIDE ALLERGY Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Azelastine Hydrochloride Allergy patents expire, and when can generic versions of Azelastine Hydrochloride Allergy launch?

Azelastine Hydrochloride Allergy is a drug marketed by Apotex and is included in one NDA.

The generic ingredient in AZELASTINE HYDROCHLORIDE ALLERGY 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 Azelastine Hydrochloride Allergy

A generic version of AZELASTINE HYDROCHLORIDE ALLERGY was approved as azelastine hydrochloride by APOTEX INC on April 30th, 2009.

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for AZELASTINE HYDROCHLORIDE ALLERGY?
  • What are the global sales for AZELASTINE HYDROCHLORIDE ALLERGY?
  • What is Average Wholesale Price for AZELASTINE HYDROCHLORIDE ALLERGY?
Summary for AZELASTINE HYDROCHLORIDE ALLERGY
Drug patent expirations by year for AZELASTINE HYDROCHLORIDE ALLERGY
Recent Clinical Trials for AZELASTINE HYDROCHLORIDE ALLERGY

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

SponsorPhase
MEDA Pharma GmbH & Co. KGPhase 2
SandozPhase 1
Mermaid Medicine®N/A

See all AZELASTINE HYDROCHLORIDE ALLERGY clinical trials

Pharmacology for AZELASTINE HYDROCHLORIDE ALLERGY

US Patents and Regulatory Information for AZELASTINE HYDROCHLORIDE ALLERGY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex AZELASTINE HYDROCHLORIDE ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 216421-001 May 29, 2024 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

AZELASTINE HYDROCHLORIDE ALLERGY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Azelastine Hydrochloride Allergy Treatments

Introduction

Azelastine hydrochloride, a potent second-generation antihistamine, has been gaining significant traction in the global pharmaceutical market due to its efficacy in treating allergic conditions such as allergic rhinitis and conjunctivitis. Here, we delve into the market dynamics and financial trajectory of azelastine hydrochloride, highlighting key drivers, market size, and future projections.

Growing Prevalence of Allergic Conditions

The increasing prevalence of allergic rhinitis and other allergy disorders worldwide is a primary driver of the azelastine market. Allergic rhinitis, characterized by symptoms like sneezing, nasal congestion, itching, and rhinorrhea, affects a substantial portion of the global population. Factors such as urbanization, pollution, lifestyle changes, and increased allergen exposure contribute to the rising global prevalence of these conditions[1][4].

Market Size and Projections

As of 2024, the global azelastine market is valued at approximately USD 1.152 billion. This market is expected to expand significantly, reaching USD 1.755 billion by 2031, with a compound annual growth rate (CAGR) of 6.20% from 2024 to 2031[4].

Regional Analysis

North America

North America is a key player in the human antihistamine drug market, including azelastine. In 2023, this region held a substantial 37.2% market share, driven by increased awareness about allergy management, a high incidence of allergic conditions, and a proactive approach to healthcare[3].

Asia Pacific

The Asia Pacific region is expected to experience significant growth due to rising awareness of allergic diseases, rapid urbanization, industrialization, and increasing pollution levels. Countries like China and India are contributing to an increase in respiratory allergies, making this region a crucial market for azelastine[1][4].

Advances in Medication Delivery

Advances in medication delivery methods, particularly the development of nasal sprays and eye drops containing azelastine, have enhanced the drug's accessibility and convenience. These formulations improve therapy efficacy, patient compliance, and the speed of action, making azelastine a preferred choice for treating allergic rhinitis and conjunctivitis[1][4].

Cost-Effectiveness and Budget Impact

A budget impact analysis of azelastine hydrochloride/fluticasone propionate (AzeFlu) nasal spray in Saudi Arabia indicates that introducing this fixed-dose combination can offer cost-neutral to cost-saving benefits compared to using multiple combination therapies. This analysis suggests that AzeFlu could result in cost savings through reduced healthcare provider visits and lower medication burdens[2].

Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of azelastine hydrochloride in relieving symptoms of perennial allergic rhinitis (PAR). A double-blind, placebo-controlled trial showed that a 0.15% azelastine formulation significantly improved nasal and non-nasal symptoms, with a favorable safety profile[5].

Market Segmentation

Drug Type

Second-generation antihistamines, such as azelastine, hold a significant market share due to their improved safety profiles and reduced sedative effects. In 2023, these antihistamines accounted for over 62.7% of the market share[3].

Medication Type

Over-the-counter (OTC) drugs dominate the market, reflecting consumer preference for accessible, non-prescription solutions. In 2023, OTC drugs held a 60.7% market share[3].

Route of Administration

Oral administration is the leading route, claiming 46.1% of the market share in 2023, due to its user-friendliness and widespread acceptance among patients[3].

End-User

Hospitals are the primary end-users, securing a 46.8% market share in 2023, highlighting their crucial role in addressing diverse allergic conditions[3].

Financial Trajectory

The financial trajectory of the azelastine market is robust, driven by the growing demand for effective antihistamines. Here are some key financial indicators:

  • Market Size 2024: USD 1.152 billion[4].
  • Projected Market Size 2031: USD 1.755 billion[4].
  • CAGR 2024-2031: 6.20%[4].
  • Direct Medical Expenses for Allergic Rhinitis in the USA: Around $3.4 billion, with nearly half of this expenditure stemming from prescription medications[2].

Key Drivers

Increasing Prevalence of Allergies

The rising prevalence of allergic conditions, exacerbated by environmental factors such as pollution and climate change, is a significant driver of the azelastine market[1][4].

Growing Awareness and Healthcare Infrastructure

Increased awareness of allergic diseases, particularly in the Asia Pacific region, and expansions in healthcare infrastructure are driving the demand for azelastine[1][4].

Aging Population

The expanding geriatric population, which is more susceptible to allergy disorders, contributes to the growing demand for azelastine[1][4].

Challenges and Opportunities

Environmental Factors

Rising air pollution and climate change contribute to greater pollen levels, resulting in more frequent and severe allergy symptoms. This presents both a challenge and an opportunity for the azelastine market[4].

Competitive Landscape

The market is dynamic, with major players strategically aligning themselves to meet the increasing need for antihistamine solutions. This competitive environment drives innovation and market growth[3].

Conclusion

The azelastine market is poised for significant growth driven by the increasing prevalence of allergic conditions, advances in medication delivery, and growing awareness of allergic diseases. With a projected CAGR of 6.20% from 2024 to 2031, the market is expected to reach USD 1.755 billion by 2031.

Key Takeaways

  • The global azelastine market is valued at USD 1.152 billion in 2024 and is expected to reach USD 1.755 billion by 2031.
  • The market is driven by the growing prevalence of allergic conditions, advances in medication delivery, and increasing awareness of allergic diseases.
  • The Asia Pacific region is expected to experience significant growth due to rapid urbanization and increasing pollution levels.
  • Azelastine hydrochloride is effective and safe in relieving symptoms of perennial allergic rhinitis.
  • The introduction of fixed-dose combinations like AzeFlu can offer cost-neutral to cost-saving benefits.

FAQs

Q: What is the current market size of the azelastine market?

The global azelastine market size is approximately USD 1.152 billion in 2024[4].

Q: What is the projected growth rate of the azelastine market from 2024 to 2031?

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

Q: Which region is expected to experience significant growth in the azelastine market?

The Asia Pacific region is expected to experience significant growth due to rapid urbanization, industrialization, and increasing pollution levels[1][4].

Q: What are the key drivers of the azelastine market?

Key drivers include the increasing prevalence of allergic conditions, advances in medication delivery, growing awareness of allergic diseases, and the expanding geriatric population[1][4].

Q: Is azelastine hydrochloride effective and safe for treating allergic rhinitis?

Yes, clinical trials have demonstrated the efficacy and safety of azelastine hydrochloride in relieving symptoms of perennial allergic rhinitis[5].

Sources

  1. Verified Market Research: Azelastine Market Size & Forecast.
  2. ISPOR: A Budget Impact Analysis of Azelastine Hydrochloride/Fluticasone Propionate (AzeFlu) Nasal Spray Suspension for Patients with Allergic Rhinitis (AR) in the Kingdom of Saudi Arabia.
  3. Market.US: Human Antihistamine Drug Market Size | CAGR OF 9.9%.
  4. Cognitive Market Research: Azelastine Market Report.
  5. Frontiers in Allergy: A Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of Azelastine Hydrochloride.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.