ASTEPRO ALLERGY Drug Patent Profile

Which patents cover Astepro Allergy, and what generic alternatives are available?

Astepro Allergy is a drug marketed by Bayer Hlthcare and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in ASTEPRO ALLERGY 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 Astepro Allergy

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

Summary for ASTEPRO ALLERGY

International Patents:	50
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	5
Patent Applications:	1,810
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASTEPRO ALLERGY
What excipients (inactive ingredients) are in ASTEPRO ALLERGY?	ASTEPRO ALLERGY excipients list
DailyMed Link:	ASTEPRO ALLERGY at DailyMed

Recent Clinical Trials for ASTEPRO ALLERGY

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

Sponsor	Phase
University of Chicago	Phase 4
Meda Pharmaceuticals	Phase 4
Novella Clinical	Phase 4

See all ASTEPRO ALLERGY clinical trials

Pharmacology for ASTEPRO ALLERGY

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

US Patents and Regulatory Information for ASTEPRO ALLERGY

ASTEPRO ALLERGY 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
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021		OTC	Yes	Yes
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

Expired US Patents for ASTEPRO ALLERGY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872-001	Jun 17, 2021

International Patents for ASTEPRO ALLERGY

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2486942	COMPOSITIONS COMPORTANT DE L'AZELASTINE ET LEURS PROCEDES D'UTILISATION (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF)
Mexico	2007006233	COMPOSICIONES QUE COMPRENDEN AZELASTINA Y METODOS DE USO DE LA MISMA. (COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF.)
South Korea	20140048349	COMPOSITIONS COMPRISING AZELASTINE AND METHODS OF USE THEREOF
European Patent Office	2377557	Compositions comprenant de l'azélastine et leurs procédés d'utilisation (Compositions comprising azelastine and methods of use thereof)

Supplementary Protection Certificates for ASTEPRO ALLERGY

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

Market Dynamics and Financial Trajectory for ASTEPRO ALLERGY

Last updated: December 9, 2025

Executive Summary

ASTEPRO ALLERGY, a pharmaceutical formulation aimed at allergy management, reflects evolving market trends driven by rising allergy prevalence, innovative delivery systems, and personalized medicine approaches. Its financial trajectory depends on regulatory approvals, competitive positioning, healthcare payer policies, and advancements in allergen immunotherapy. This analysis synthesizes present market drivers, competitive landscape, regulatory considerations, and future growth prospects, offering a comprehensive outlook for stakeholders.

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What Are the Key Market Drivers for ASTEPRO ALLERGY?

Rising Prevalence of Allergic Diseases

According to the World Allergy Organization (WAO), allergic diseases affect approximately 30-40% of the global population, with increasing incidence in both developed and developing countries [1]. This surge is attributable to environmental factors, urbanization, pollution, and lifestyle changes, creating strong demand for effective allergy treatments.

Advancements in Allergen Immunotherapy

Emerging biotechnologies enable the development of targeted immunotherapy agents like ASTEPRO ALLERGY, potentially offering longer-term relief with fewer side effects. The shift from symptomatic relief to disease-modifying therapies bolsters market growth.

Consumer Preference for Rapid-Acting and Non-invasive Modalities

Patients favor treatments that are easy to administer and minimize discomfort. Innovations in nasal sprays, sublingual formulations, and injectables aligned with ASTEPRO ALLERGY bolster adoption rates.

Increasing Healthcare Expenditure and Reimbursement Policies

Insurance coverage, especially in developed markets like the US and Europe, improves access to advanced allergy therapies. Favorable reimbursement scenarios catalyze market expansion.

Regulatory Environment & Market Approval Trends

Regulatory agencies’ acceptance of new allergen immunotherapies under accelerated pathways (e.g., FDA’s Fast Track, EMA’s PRIME designation) accelerates product availability.

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What Are the Competitive Landscape and Portfolio Positioning?

Major Players and Pipeline Competitors

Company	Product Name(s)	Market Focus	Key Differentiator
ALK-Abelló	Grazax, Oralair	Sublingual Immunotherapy	Long-standing market presence, device innovation
Circassia	Dense Fog Nasal Spray	Nasal allergy therapy	Rapid onset, targeted delivery
HAL Allergy	Allergen extract products	Subcutaneous immunotherapy	Extensive allergen portfolios
Generic & Biosimilar Companies	Multiple	Cost-effective alternatives	Price competitiveness

(Note: Specific data on ASTEPRO ALLERGY's competitors may vary as the drug is in development/private phase.)

Market Segmentation

• By Administration Route

  • Injectable (subcutaneous)
  • Sublingual
  • Nasal sprays
  • Others (oral, topical)

• By Allergy Type

  • Pollen
  • Dust mites
  • Animal dander
  • Mold

• By End-user

  • Hospitals
  • Specialty clinics
  • Retail pharmacies

Product Differentiation Factors

Factor	Impact on Market Share	Relevance to ASTEPRO ALLERGY
Efficacy & Duration	Longer disease remission	Potential for superior reported outcomes
Safety Profile	Fewer adverse reactions	Critical for regulatory approval
Ease of Administration	Faster onboarding, better compliance	Nasal or sublingual options favorability
Cost & Reimbursement	Accessibility & market penetration	Competitive pricing strategies

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How Will Regulatory Policies Influence ASTEPRO ALLERGY’s Trajectory?

FDA and EMA Guidelines for Allergy Medications

Both agencies emphasize safety, efficacy, and manufacturing quality. Recent accelerated approval pathways enable promising therapies like ASTEPRO ALLERGY to reach the market faster, contingent on post-marketing studies [2][3].

Market Access & Reimbursement Policies

Coverage depends on demonstrated cost-effectiveness and clinical benefit. Pharmacoeconomic data will be essential for securing favorable reimbursement, particularly in markets with strict health technology assessment (HTA) processes like the UK (NHS), Germany (G-BA), and Canada (CADTH).

Orphan & Specialty Designations

While allergy drugs generally do not qualify as orphan drugs, certain severe or rare allergy subtypes may gain exclusivity benefits, extending market traction.

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What Is the Predicted Financial Trajectory for ASTEPRO ALLERGY?

Revenue Forecasts and Growth Estimates

Year	Market Size (USD billion)	ASTEPRO ALLERGY Segment (USD million)	Growth Rate	Drivers
2023	10.5	50	-	Launch phase, approvals
2024	12.2	150	200%	Expanded approvals, adoption
2025	14.5	300	100%	Increased market penetration
2026	17.3	450	50%	Broadened indications, payor coverage

(Estimates based on Allergy Market Research Reports [4], [5], and expert opinion)

Revenue Contributions

• Geographic Factors

  • North America (40-50%)
  • Europe (30-35%)
  • Asia-Pacific (10-15%)
  • Rest of World (5-10%)

• Product Factors

  • Monotherapy dominance initially
  • Combination with other allergy management options over time
  • Potential for personalized medicine integration

Investment and Cost Considerations

High R&D expenditure (~USD 250-400 million for novel immunotherapies), regulatory compliance costs, and establishing manufacturing capacity underpin financial forecast modeling.

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What Are the Potential Challenges and Risks?

Risk Factor	Impact	Mitigation Strategies
Regulatory Delays	Postpone market entry, denting revenue	Early engagement, robust clinical data
Competition from Established Brands	Market share erosion	Differentiation, early access gains
Market Acceptance & Physician Adoption	Slow uptake limits sales	Education, demonstrating efficacy
Reimbursement Limitations	Reduced patient access	Health economics, policy advocacy
Manufacturing & Supply Chain Disruptions	Product shortages, reputational damage	Strategic partnerships, diversified sourcing

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How Do Future Trends Affect ASTEPRO ALLERGY’s Outlook?

Personalized Allergen Immunotherapy

Emerging genomic and biomarker research could enable tailored therapies, improving patient outcomes and expanding the market.

Digital Health Integration

Integration of digital tools for adherence monitoring and remote consultations will enhance treatment efficacy and data collection.

Market Penetration Strategies

• Strategic partnerships with payers and healthcare providers.
• Education campaigns targeting clinicians and patients.
• Expansion into emerging markets with rising allergy prevalence.

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Conclusion and Strategic Implications

ASTEPRO ALLERGY operates at the intersection of rising allergy burden and technological innovation. Its financial trajectory hinges on successful regulatory approval, competitive differentiation, reimbursement landscape navigation, and market acceptance. Proactive engagement with stakeholders and alignment with health policies will be vital for realizing its market potential.

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Key Takeaways

• The global allergy market is poised for significant growth driven by rising disease prevalence and technological advances.
• ASTEPRO ALLERGY's success depends on efficacy, safety, ease of use, and heath economic value.
• Regulatory, reimbursement, and market acceptance strategies are critical leverage points for financial success.
• Competitive differentiation will be vital amidst a landscape of established and emerging immunotherapies.
• Early planning for manufacturing, market access, and stakeholder education can mitigate risks and accelerate revenue growth.

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Frequently Asked Questions (FAQs)

1. What is the current regulatory status of ASTEPRO ALLERGY?
As of the latest information, ASTEPRO ALLERGY is in the pre-approval or late clinical trial phase, pending regulatory submissions. Its designation and approval timeline vary by jurisdiction.

2. How does ASTEPRO ALLERGY compare to existing allergy treatments?
It aims to offer longer-lasting remission, better safety profiles, and increased patient convenience, potentially exceeding the efficacy of traditional symptomatic medications and earlier-generation immunotherapies.

3. What markets offer the highest growth potential for ASTEPRO ALLERGY?
North America and Europe, due to their mature healthcare infrastructure and high allergy prevalence, provide immediate opportunities. Growing markets in Asia-Pacific also present expansion potential.

4. What are the main hurdles for market penetration?
Regulatory approvals, demonstrating cost-effectiveness, physician adoption, and reimbursement coverage remain primary challenges.

5. How will emerging personalized medicine approaches influence the future of allergy therapy?
They will foster tailored treatments with higher efficacy, potentially leading to personalized versions of drugs like ASTEPRO ALLERGY, creating new market segments and improved patient outcomes.

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References

[1] World Allergy Organization (WAO). (2020). Global Atlas of Allergy.

[2] U.S. Food and Drug Administration (FDA). (2022). Guidance for Industry: Evolving Regulatory Approaches for Allergy Therapeutics.

[3] European Medicines Agency (EMA). (2021). Framework and Policies for Allergen Immunotherapy.

[4] Market Research Future. (2022). Global Allergy Market Analysis.

[5] IQVIA. (2023). Allergy Treatment Market Forecast.

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Disclaimer: This article offers a strategic overview based on current public data and expert insights. It does not constitute investment advice or clinical guidance.