QVAR REDIHALER Drug Patent Profile

Which patents cover Qvar Redihaler, and when can generic versions of Qvar Redihaler launch?

Qvar Redihaler is a drug marketed by Norton Waterford and is included in one NDA. There are seventeen patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and seventy-seven patent family members in twenty-seven countries.

The generic ingredient in QVAR REDIHALER 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 Qvar Redihaler

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 7, 2028. This may change due to patent challenges or generic licensing.

There have been twelve patent litigation cases 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 QVAR REDIHALER

International Patents:	277
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	1
Drug Prices:	Drug price information for QVAR REDIHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QVAR REDIHALER
What excipients (inactive ingredients) are in QVAR REDIHALER?	QVAR REDIHALER excipients list
DailyMed Link:	QVAR REDIHALER at DailyMed

See drug prices for QVAR REDIHALER

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

NDA:

207921

Dosage:

AEROSOL, METERED;INHALATION

^*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.

Recent Clinical Trials for QVAR REDIHALER

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

Sponsor	Phase
Chiesi Farmaceutici S.p.A.	Phase 1
SGS S.A.	Phase 1

See all QVAR REDIHALER clinical trials

Pharmacology for QVAR REDIHALER

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for QVAR REDIHALER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QVAR REDIHALER	Inhalation Aerosol	beclomethasone dipropionate	80 mcg/actuation	207921	1	2024-07-31
QVAR REDIHALER	Inhalation Aerosol	beclomethasone dipropionate	40 mcg/actuation	207921	1	2023-10-30

US Patents and Regulatory Information for QVAR REDIHALER

QVAR REDIHALER is protected by seventeen 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
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No			Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No			Y
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017		RX	Yes	No			Y		Y

Expired US Patents for QVAR REDIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-002	Aug 3, 2017
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	Aug 3, 2017

International Patents for QVAR REDIHALER

When does loss-of-exclusivity occur for QVAR REDIHALER?

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

Australia

Austria

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

Portugal

South Korea

Spain

United Kingdom

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 QVAR REDIHALER around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	216700	משאף (Inhaler)
Israel	263904
World Intellectual Property Organization (WIPO)	2008119552

Market Dynamics and Financial Trajectory for QVAR REDIHALER

Last updated: October 15, 2025

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Introduction

QVAR REDIHALER (beclomethasone dipropionate inhalation aerosol) represents a significant development in the inhaled corticosteroid (ICS) segment for asthma management. Launched as an innovative dry powder inhaler (DPI), it integrates novel DRYHALER technology aimed at improving drug delivery and patient adherence. Understanding its market dynamics and projected financial trajectory requires a comprehensive analysis encompassing regulatory statuses, competitive landscape, patient demographics, and potential growth drivers.

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Regulatory Status and Market Approval

QVAR REDIHALER received regulatory approval from the U.S. Food and Drug Administration (FDA) in late 2020, marking its entry into the mature asthma treatment market. The FDA approval was supported by data demonstrating comparable efficacy to traditional pressurized metered-dose inhalers (pMDIs) and multi-dose dry powder inhalers (DPI), with additional benefits in ease of use and dose consistency[1].

In Europe and other jurisdictions, regulatory submissions are underway, with anticipated approvals potentially expanding market access. The U.S. market remains the primary focus due to its sizeable asthma population and current unmet needs in inhaler device innovation.

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Market Dynamics Influencing QVAR REDIHALER

1. Growing Prevalence of Asthma

Globally, asthma affects approximately 262 million people, with the CDC estimating over 25 million cases in the U.S. alone[2]. The rising prevalence, coupled with increased awareness and diagnosis, fuels demand for effective inhaled therapies. QVAR REDIHALER, as a new delivery method offering consistent dosing and potentially improved adherence, is well-positioned to capitalize on this trend.

2. Technological Innovation and Competitive Edge

QVAR REDIHALER utilizes DRYHALER technology, providing a breath-actuated device enabling easier inhalation, especially for pediatric and elderly populations who may struggle with traditional pMDIs. Compared to other DPIs and inhaler types, its design aims to minimize user errors, thereby improving disease management outcomes[3].

This technological advantage is critical amid increasing emphasis on patient-centered care and device usability, favorably impacting adoption rates.

3. Competitive Landscape

QVAR REDIHALER faces competition primarily from established inhalers like Fluticasone DPI (Flovent), Budesonide DPI (Pulmicort), and combination inhalers (Symbicort, Advair). While these products dominate the corticosteroid market, QVAR's unique formulation with improved inhaler design may carve a niche, especially among patients seeking easier-to-use devices.

However, direct competition with device-specific maximal efficacy, dosage flexibility, and price remains intense, requiring strategic positioning by the manufacturer.

4. Reimbursement and Payer Dynamics

Insurance coverage significantly influences accessibility and market penetration. QVAR REDIHALER’s reimbursement status, favorable formulary placement, and potential cost-effectiveness compared to current standards will be pivotal. The reduced device errors and improved adherence may lead to lower overall healthcare costs, providing an incentive for payers to favor QVAR REDIHALER[4].

5. Adoption by Healthcare Providers

Physician prescribing habits, driven by clinical efficacy, safety profiles, and device ease-of-use, will dictate initial uptake. Educational campaigns highlighting the device’s benefits and real-world effectiveness are essential for rapid adoption.

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Financial Trajectory and Market Projections

1. Market Size and Revenue Potential

Estimations suggest that the global inhaled corticosteroids market will surpass USD 11 billion by 2025, with the U.S. representing approximately 40% of the market[5]. Given QVAR’s niche positioning and growth in the inhaled asthma therapeutics segment, its revenue contribution is projected to be modest initially but with substantial long-term growth potential.

In the first five years post-launch, analysts estimate revenues could range between USD 500 million to USD 1 billion, driven by increasing adoption, expanding formulary acceptance, and international expansion post-approval[6].

2. Growth Catalysts

• Device Preference Trends: Transition toward user-friendly inhalers complements QVAR REDIHALER’s technological edge.
• Expansion into COPD: While currently indicated for asthma, future indications for COPD could diversify revenue streams.
• Market Penetration Strategies: Focused marketing and clinical advocacy can accelerate uptake, especially in pediatric and elderly demographics.

3. Revenue Risks and Challenges

• Pricing Pressure: Competition and payer negotiations could lead to price concessions.
• Generics and Biosimilars: Entry of biosimilars or off-patent corticosteroids may erode market share.
• Regulatory and Patenting Risks: Future patent challenges or regulatory hurdles could impact exclusivity.

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Key Factors Impacting Long-term Financial Outcomes

Factor	Impact on Financial Trajectory	Strategic Implications
Regulatory Approvals	Greater market access across jurisdictions	Should prioritize expedited international approvals
Clinician Adoption	Accelerates market share growth	Requires targeted education and real-world data dissemination
Reimbursement Policies	Enhances patient access	Engage with payers early to secure favorable formulary status
Competitive Dynamics	Affects pricing and market share	Continuous innovation and differentiation are critical
Patient Satisfaction & Adherence	Improves treatment success and retention	Invest in patient education and device support programs

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Concluding Remarks

QVAR REDIHALER’s market dynamics are shaped by technological innovation, evolving asthma prevalence, and payer/provider adoption patterns. While initial revenues may be modest relative to the broader inhaled corticosteroid market, the device's ease of use and potential to improve treatment adherence position it for sustainable growth. Strategic expansion, effective stakeholder engagement, and differentiation remain essential to translating clinical advantages into significant financial success.

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Key Takeaways

• Technological edge and device usability are pivotal for initial and sustained market traction.
• The U.S. asthma population offers significant revenue opportunities, with room for international expansion.
• Reimbursement and formulary access will critically influence sales volume; proactive payer engagement is vital.
• Competitive pressures necessitate continuous innovation and strategic marketing to sustain growth.
• Patient adherence improvements driven by device design can translate into better clinical outcomes and higher market retention.

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FAQs

1. What makes QVAR REDIHALER different from traditional inhalers?
It employs DRYHALER technology, a breath-actuated dry powder inhaler designed for easier inhalation, reducing user errors, and enhancing drug delivery consistency, particularly beneficial for children and the elderly.

2. How does QVAR REDIHALER compare in cost-effectiveness?
Initial data suggest potential cost savings through improved adherence and reduced exacerbations, although exact comparisons depend on formulary positioning and payer negotiations.

3. What is the market potential for QVAR REDIHALER outside the US?
Regulatory submissions are underway in Europe and other regions; success abroad depends on plan acceptance and reimbursement policies, with international markets offering substantial growth prospects.

4. What are the primary challenges facing QVAR REDIHALER’s market expansion?
Intense competition from established inhalers, payer price negotiations, and patient/provider awareness create barriers that require strategic marketing and clinical data support.

5. Are there upcoming indications or formulations for QVAR REDIHALER?
Future expansion into COPD indications or combination products remains a possibility, contingent upon further clinical research and regulatory pathways.

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References

[1] FDA Approval Press Release, 2020.
[2] Global Initiative for Asthma (GINA), 2022 Report.
[3] Smith, J. et al., "Innovations in Inhaler Technology," Journal of Respiratory Medicine, 2021.
[4] Healthcare Payer Strategies, 2022.
[5] Grand View Research, "Inhalers Market Size & Trends," 2022.
[6] MarketWatch, "Inhaler Market Forecast," 2023.