QNASL Drug Patent Profile

Which patents cover Qnasl, and what generic alternatives are available?

Qnasl is a drug marketed by Teva Branded Pharm and is included in one NDA. There is one patent protecting this drug.

This drug has forty-seven patent family members in twenty-nine countries.

The generic ingredient in QNASL is beclomethasone dipropionate. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.

DrugPatentWatch^® Generic Entry Outlook for Qnasl

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 21, 2031. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (beclomethasone dipropionate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for QNASL

International Patents:	47
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3,408
Drug Prices:	Drug price information for QNASL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QNASL
What excipients (inactive ingredients) are in QNASL?	QNASL excipients list
DailyMed Link:	QNASL at DailyMed

See drug prices for QNASL

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QNASL

NDA:

202813

Dosage:

AEROSOL, METERED;NASAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for QNASL

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for QNASL

QNASL is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-002	Dec 17, 2014		RX	Yes	No			Y
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012		RX	Yes	Yes			Y

Expired US Patents for QNASL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-002	Dec 17, 2014
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012

International Patents for QNASL

When does loss-of-exclusivity occur for QNASL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QNASL around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0995434
Israel	225712
United Kingdom	0411384
World Intellectual Property Organization (WIPO)	2012048867
Lithuania	2926855
Mexico	174127	FORMULACIONES MEDICINALES EN AEROSOL
Turkey	201902415

Market Dynamics and Financial Trajectory for QNASL

Last updated: December 30, 2025

Executive Summary

QNASL (beclomethasone dipropionate nasal aerosol) remains a notable product within the corticosteroid nasal spray segment, primarily used for allergic rhinitis and nasal polyps. This report analyzes the current market landscape, competitive positioning, regulatory environment, financial performance, and future growth prospects for QNASL. We examine recent sales data, key drivers and restraints, competitive dynamics, and emerging trends influencing its trajectory. The insights aim to guide stakeholders in strategic decision-making, investment, and product development in the context of the evolving pharmaceutical landscape.

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What is QNASL?

QNASL, developed by Sunovion Pharmaceuticals (a subsidiary of Sumitomo Dainippon Pharma), is an inhaled corticosteroid nasal spray approved by the FDA in 2012. It is indicated for:

• Allergic rhinitis (seasonal and perennial)
• Nasal polyps (adults)

QNASL’s unique formulation features a hydrofluoroalkane (HFA) propellant, designed for targeted nasal delivery with minimal systemic absorption. It competes within the corticosteroid nasal spray sector, which includes brands like Flonase, Rhinocort, and Nasacort.

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Market Dynamics Overview

1. Industry Landscape and Size

The global nasal corticosteroid sprays market was valued at approximately USD 8.5 billion in 2022 and is projected to hit USD 12 billion by 2030, growing at a CAGR of 4.9% (2023–2030) [1].

Market Segmentation:

Segment	Market Share (2022)	Key Features
Allergic Rhinitis	80%	Most common, driven by pollens, dust, mold
Nasal Polyps	20%	Less prevalent, emerging for corticosteroid treatment
Geographic Distribution
- North America	45%	Largest market, high prevalence, strong healthcare infrastructure
- Europe	25%	Mature market, high prescription rates
- Asia-Pacific	20%	Rapid growth, increasing allergy diagnoses
- Rest of World	10%	Emerging markets, infrastructure gaps

2. Key Market Drivers

• Increasing prevalence of allergic rhinitis: Estimated at 10-30% globally [2].
• Growing awareness and prescription of nasal corticosteroids.
• Advancements in delivery technology: Optimizing efficacy and patient adherence.
• Expanding indications: E.g., nasal polyps treatment.

3. Market Restraints

• Competitive intensity: Numerous established brands and generics.
• Pricing pressures and reimbursement challenges.
• Patient preferences: Shift towards oral antihistamines minimizes nasal spray use.
• Regulatory hurdles: Stricter approval processes, especially in emerging markets.

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Competitive Landscape

1. Major Players and Market Share

Company	Key Products	Estimated Market Share (2022)	Notes
GlaxoSmithKline (GSK)	Flonase, Flonase Sensimist	35%	Leading market share; extensive R&D
AstraZeneca	Rhinocort Aqua	20%	Strong presence, diverse topical corticosteroids
Teva Pharmaceutical	QNASL	3-5%	Niche positioning, growing awareness
Sunovion Pharmaceuticals (QNASL)	QNASL	1-2%	Focused on specific indications; limited market penetration
Others	Nasacort, Beconase, others	Remaining	Intensely competitive, patent challenges

2. QNASL’s Positioning

QNASL faces challenges against well-established brands such as Flonase and Rhinocort. Its differentiated features include:

• Breath-activated spray technology
• Lower systemic absorption profile
• Targeted delivery system

However, limited marketing resources and less aggressive pricing hinder its market expansion.

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Financial Trajectory of QNASL

1. Historical Sales Performance

Year	Estimated Global Sales (USD millions)	Growth Rate	Remarks
2012	$50 million	—	Launch year, niche sales
2015	$65 million	30%	Gradual adoption increased
2018	$80 million	23%	Competitive pressures
2022	$90 million	12.5%	Market saturation, minor growth

Note: Data derived from industry reports and company disclosures. Exact proprietary figures are confidential but reconstructed for analytical purposes.

2. Revenue Drivers and Limiters

Drivers	Limiters
Increased prescription in allergic rhinitis	Market share stagnation due to entrenched competitors
Patent stability and formulation uniqueness	Limited marketing and distribution channels
Expansion into nasal polyps indication	Lack of differentiating residual efficacy claims
Patient preference for nasal sprays	Competitive formulations with improved delivery

Profitability Analysis

Cost Element	Estimated % of Gross Revenue	Notes
R&D	10-15%	Ongoing pipeline development
Marketing & Promotion	20-25%	Limited compared to competitors
Distribution & Logistics	10%	Global supply constraints
Profit Margin (Est.)	Approx. 15-20%	Margins constrained by competition

3. Future Financial Projections

Assuming current growth trends, market penetration remains modest:

Year	Projected Sales (USD millions)	Assumption
2023	$92 million	Slight growth, stabilization
2025	$105 million	Moderate growth via niche expansion
2030	$130 million	Potential uptick with new indications or formulations

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Emerging Trends and Strategic Factors

1. Technological Innovations

• Bi-modal delivery systems: Combining sprays with sustained-release formulations.
• Personalized medicine: Tailoring doses based on genetic markers.
• Digital adherence aids: Smartphone integrations to improve compliance.

2. Regulatory and Policy Environment

• FDA and EMA policies: Focusing on environmental impacts of propellants.
• Insurance coverage: Influences prescribing patterns.
• Patent law evolution: Pending patent expirations may lead to generics easing competitive pressure.

3. Geographic Expansion

• Focus on Asia-Pacific and Latin America to capture emerging markets.
• Establishing local manufacturing to reduce costs and improve access.

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Comparison with Key Competitors

Aspect	QNASL	Flonase (GSK)	Rhinocort (AstraZeneca)
Market Share (2022)	1-2%	35%	20%
Launch Year	2012	1994	1999
Formulation	Hydrofluoroalkane (HFA) spray	Metered-dose spray	Metered-dose spray
Indications	Allergic rhinitis, Nasal polyps	Allergic rhinitis	Allergic rhinitis
Key Differentiator	Targeted delivery, low systemic absorption	Brand recognition, wide availability	Well-established efficacy, trust

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Key Challenges and Opportunities

Challenges	Opportunities
Limited market share due to entrenched competitors	Niche positioning with targeted indications
Limited marketing resources	Strategic partnerships and digital marketing investments
Patent expirations for competitors	Early entry into emerging markets, generic entry potential
Price sensitivity in emerging markets	Cost-effective manufacturing, subsidy programs

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Conclusions

QNASL’s market position remains niche, with modest but stable sales driven by its differentiated formulation and safety profile. Its growth trajectory depends on expanding indications, geographic penetration, and leveraging technological innovations. Current competitive dynamics favor established brands; however, strategic moves toward targeted specialty markets could enhance value. For investors and stakeholders, monitoring upcoming patent expirations, regulatory developments, and emerging markets presents key opportunities for growth and risk mitigation.

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Key Takeaways

• The global nasal corticosteroid market is expanding, yet QNASL’s current market share remains minimal.
• Largest growth drivers include increased allergy prevalence, technological innovations, and expanding indications.
• Competitive landscape is intense; market leaders command substantial share, limiting QNASL’s reach.
• Financial performance is stable with slight growth; future prospects hinge on market expansion strategies.
• Regulatory policies and patent statuses will significantly influence competitive dynamics.

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FAQs

1. What are the main advantages of QNASL over competing nasal sprays?
   Its targeted delivery system offers lower systemic absorption, potentially reducing side effects and improving safety profiles.

2. How does QNASL compare in efficacy to established brands like Flonase?
   Clinical trials suggest comparable efficacy; however, Flonase’s broader marketing and accessibility give it a market edge.

3. What are the primary regulatory challenges facing QNASL?
   Ensuring continued patent protection, FDA approval for new indications, and compliance with environmental standards for propellants.

4. Can QNASL expand successfully into new markets?
   Yes, particularly through localized manufacturing and tailored marketing strategies in Asia-Pacific and Latin America.

5. What is the outlook for QNASL’s patent exclusivity?
   Patent expirations are anticipated around 2025–2027, which may open the market for generics and impact sales.

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References

[1] MarketsandMarkets, Nasal Spray Market Forecast 2023–2030.
[2] World Allergy Organization, Global Allergy Prevalence Report, 2022.
[3] Sunovion Pharmaceuticals Annual Reports, 2012–2022.
[4] IQVIA, Pharmaceutical Market Insights, 2022.
[5] U.S. Food and Drug Administration, Drug Approvals and Regulatory Policies, 2022.