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

Constraining patent/regulatory exclusivity:

10,188,811

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.

This potential generic entry date is based on patent 10,188,811.

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	10,188,811		Y
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012		RX	Yes	Yes	10,188,811		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	5,776,432
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012	5,776,432
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012	5,683,677
Teva Branded Pharm	QNASL	beclomethasone dipropionate	AEROSOL, METERED;NASAL	202813-001	Mar 23, 2012	5,605,674

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
China	106178205
China	103282070
Australia	4595689
Chile	2013000958

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: QNASL

Last updated: July 27, 2025

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Introduction

QNASL (beclomethasone dipropionate nasal aerosol) is a corticosteroid formulated primarily for the treatment of allergic rhinitis and other nasal inflammatory conditions. As a well-established treatment modality, its market dynamics are influenced by a range of factors—including competitive landscape, regulatory shifts, and evolving healthcare policies. This article examines the current and projected financial trajectory of QNASL, contextualizing it within contemporary pharmaceutical market forces.

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Market Landscape and Positioning

QNASL was developed by Teva Pharmaceuticals and gained FDA approval as a nasal spray intended for allergic rhinitis management. Its position in the pharmaceutical market is primarily as a generic or off-brand alternative, with a focus on efficacy and affordability. The drug's market interest hinges on a few critical elements:

• Therapeutic Radius: The drug's efficacy in reducing nasal inflammation places it among standard treatments for allergic rhinitis, a condition affecting approximately 20-30% of adults globally.[1]
• Availability and Competition: QNASL faces competition from both branded corticosteroids such as Flonase (fluticasone) and Nasacort (triamcinolone), as well as other generics. The competitive landscape favors cost-conscious healthcare systems seeking efficacy at lower prices.
• Patent and Regulatory Environment: While QNASL isn’t under patent protection anymore, recent regulatory breakthroughs and approval processes for similar drugs influence its market potential. Regulatory policies favoring generic proliferation could drive volume growth.

Market Drivers

1. Prevalence of Allergic Rhinitis: The rising incidence globally, driven by environmental factors like pollution and climate change, sustains demand for corticosteroids like QNASL.
2. Affordable Alternatives: As healthcare systems shift towards cost-effective treatments, the demand for generic nasal corticosteroids compensates for reduced demand for expensive branded drugs.
3. Older Patient Demographics: Aging populations, particularly in Western markets, bolster the demand for accessible, reliable allergic rhinitis therapies.
4. Physician Prescribing Trends: Growing familiarity and confidence in generic formulations augment their market share.

Market Challenges

• Intense Competition: The market is saturated with multiple corticosteroids, reducing QNASL’s market share unless it offers significant advantages.
• Brand Loyalty: Patients and physicians often prefer established brands, influencing uptake of generic options like QNASL.
• Regulatory Variability: Differing approvals and regulatory standards across geographies can restrict expansion or delay market entry.

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Financial Trajectory Analysis

Historical Performance

While specific revenue figures for QNASL are proprietary or non-disclosed publicly, the drug's trajectory has generally aligned with the growth of the global allergic rhinitis market, which was valued at approximately $13.4 billion in 2021 and is projected to grow at a CAGR of around 4-5% through 2030.[2]

QNASL's revenue historically has been modest relative to newer entrants and dominant brands, constrained further by its mostly generic status and brand recognition barriers. However, it has maintained stable volumes owing to its affordability and consistent prescription patterns among general practitioners.

Current Financial Outlook

Given the increasing prevalence of allergic rhinitis and healthcare systems' emphasis on cost-efficiency, generic corticosteroids like QNASL are expected to sustain a moderate growth trajectory. The key financial factors include:

• Market Penetration: Post-patent expiry, market penetration stabilizes but can be enhanced through aggressive marketing and expanding geographic reach.
• Manufacturing Costs: As a generic, QNASL benefits from lower manufacturing costs, which supports healthier margins, especially as economies of scale increase.
• Pricing Strategies: Price competition remains fierce; however, slight price reductions or bundling could boost volume sales.

Future Growth Projections

Based on current trends:

• Moderate Growth (CAGR 3-4%): The ongoing expansion in allergy prevalence and increased acceptance of generics point toward steady growth.
• Market Expansion Potential: Entry into emerging markets, which account for a significant share of allergic rhinitis cases but have underpenetrated pharmacotherapy markets, could bolster revenues.
• Pipeline and Reformulation Opportunities: Innovations—such as combination therapies or improved delivery mechanisms—could extend product lifecycle and financial yields.

Regulatory and Patent Considerations

QNASL no longer possesses patent protections; thus, generic entry is permitted without patent infringement. Regulatory frameworks continue to favor broader access post-approval, potentially lowering barriers for competitor entry but also presenting an opportunity for Teva and other manufacturers to improve formulations or delivery methods.

Risks and Uncertainties

• Market Saturation: High competition may suppress revenue.
• Pricing Pressures: Payers' push for lower-cost alternatives could erode margins.
• Regulatory Hurdles: Changes in approval standards or reimbursement policies may impact sales.

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Implications for Investors and Stakeholders

Investors in QNASL’s parent company or generic pharmaceutical portfolios should monitor emerging competition, evolving regulatory landscapes, and market expansion strategies for allergic rhinitis therapies. While near-term prospects appear stable, the long-term financial trajectory will depend heavily on market access, pricing strategies, and portfolio diversification.

Strategic Recommendations

• Market Diversification: Focus on expanding into emerging markets where allergy prevalence is rising.
• Innovation: Invest in delivery innovations or combination therapies to differentiate from competitors.
• Pricing Strategy: Balance competitive pricing with margin preservation by leveraging manufacturing efficiencies.

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Key Takeaways

• QNASL thrives primarily in a highly competitive, cost-sensitive segment of the allergic rhinitis market.
• Its financial growth prospects hinge on market penetration, geographic expansion, and competitive pricing.
• The global increase in allergy prevalence, especially in aging and urban populations, supports steady demand.
• Patent expiry has opened the door for intense generic competition, demanding strategic differentiation.
• Strategic innovation and market expansion are critical to enhancing long-term revenue streams.

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Frequently Asked Questions (FAQs)

1. What is the primary therapeutic benefit of QNASL?
   QNASL delivers targeted corticosteroid therapy to reduce nasal inflammation in allergic rhinitis, providing symptom relief and improving patient quality of life.

2. How does QNASL compare to other corticosteroids in terms of efficacy?
   Clinical trials indicate comparable efficacy to other corticosteroids like Flonase, with minor variations based on patient response. Its main advantage remains cost-effectiveness.

3. What factors could impact QNASL's future market size?
   Market size will be influenced by regulatory developments, competition from new formulations, generics, or biosimilars, and shifts in healthcare policies favoring or limiting generic prescribing.

4. Are there any upcoming innovations or formulations for QNASL?
   Currently, no major reformulations have been publicly announced. However, future research may focus on enhanced delivery systems or combination therapies to sustain competitiveness.

5. What regions offer the most growth potential for QNASL?
   Emerging markets with rising allergy prevalence and expanding healthcare infrastructure present promising growth opportunities beyond traditional markets in North America and Europe.

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References

[1] World Allergy Organization. (2021). Allergic Rhinitis Overview.
[2] MarketsandMarkets. (2022). Allergic Rhinitis Market Forecast to 2030.