QVAR 80 Drug Patent Profile

When do Qvar 80 patents expire, and what generic alternatives are available?

Qvar 80 is a drug marketed by Teva Branded Pharm and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-two patent family members in twenty-four countries.

The generic ingredient in QVAR 80 is beclomethasone dipropionate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.

DrugPatentWatch^® Generic Entry Outlook for Qvar 80

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

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 80

International Patents:	192
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	65
DailyMed Link:	QVAR 80 at DailyMed

Paragraph IV (Patent) Challenges for QVAR 80

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
QVAR 80	Inhalation Aerosol	beclomethasone dipropionate	40 mcg/actuation and 80 mcg/actuation	020911	1	2020-01-10

US Patents and Regulatory Information for QVAR 80

QVAR 80 is protected by eight US patents.

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	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No	10,561,808		Y
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No	9,808,587		Y
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No	11,395,889		Y
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000		DISCN	Yes	No	10,022,510		Y

Expired US Patents for QVAR 80

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000	5,776,432
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000	5,605,674
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000	6,446,627
Teva Branded Pharm	QVAR 80	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-001	Sep 15, 2000	6,352,684

International Patents for QVAR 80

See the table below for patents covering QVAR 80 around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	8828477
Spain	2222525
South Korea	20160066563
Slovenia	2514467

QVAR 80 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for QVAR 80

Introduction

QVAR 80, a formulation of beclomethasone dipropionate, is a crucial medication in the treatment of asthma, particularly through its delivery via the QVAR RediHaler. This article delves into the market dynamics and financial trajectory of QVAR 80, highlighting key factors influencing its growth and performance.

Market Size and Growth Projections

The inhaler corticosteroid device market, which includes QVAR 80, is projected to grow significantly. As of 2023, the market size was valued at USD 616.09 million and is expected to reach USD 886.4 million by 2031, growing at a CAGR of 4.6% during the forecast period[1].

Competitive Landscape

The competitive landscape of the inhaler corticosteroid device market is dynamic, with several key players. QVAR 80, specifically the QVAR RediHaler, has gained traction due to its innovative breath-actuated delivery system. This system simplifies the use of the inhaler, making it more patient-friendly and effective in managing asthma symptoms[2].

End-User Segment Growth

The hospitals and clinics segment is experiencing rapid growth due to the increasing prevalence of respiratory diseases. These healthcare facilities serve as primary points of care where patients receive prescriptions for inhaler corticosteroid devices like QVAR 80. The role of healthcare professionals in educating patients about proper inhaler usage further drives demand within this segment[1].

Regional Market Dominance

North America holds a significant revenue share in the inhaler corticosteroid device market. The high prevalence of respiratory diseases such as asthma and COPD, advanced healthcare infrastructure, and favorable reimbursement policies contribute to this dominance. Ongoing research and development activities in the region also support the growth of QVAR 80[1].

Product Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of QVAR RediHaler. Studies have shown that patients treated with QVAR RediHaler experienced significant improvements in lung function, including FEV1 and morning PEF, compared to placebo. These trials also highlighted the reduction in asthma symptoms and the need for rescue medication, supporting the clinical justification for its approval[2].

Regulatory Approvals and Launch

QVAR RediHaler received FDA approval in 2017 and became commercially available in both 40mcg and 80mcg strengths in the first quarter of 2018. This approval marked a significant milestone in expanding treatment options for patients with persistent symptomatic asthma[4].

Financial Performance of Teva Pharmaceuticals

Teva Pharmaceuticals, the manufacturer of QVAR 80, has experienced fluctuations in revenue due to various market and economic factors. Despite challenges posed by the COVID-19 pandemic, Teva reported a stable financial performance in recent years. For instance, in the third quarter of 2019, QVAR revenues in North America increased by 68% to $60 million compared to the same period in 2018[5].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the pharmaceutical industry. While there was a decrease in total script volume and patient visits to healthcare facilities, Teva managed to compensate through cost savings and maintained non-GAAP EBITDA in line with expectations. The pandemic also led to increased focus on digital health solutions and remote patient care, which could benefit the long-term adoption of inhaler devices like QVAR 80[3].

Challenges and Opportunities

Despite the positive growth projections, the market faces challenges such as high treatment costs, misuse of funding, and lack of awareness. Patent expirations leading to generic competition also impact pricing and market share. However, partnerships aimed at accelerating innovation and market penetration, along with a focus on patient education and sustainability initiatives, present opportunities for growth[1].

Sustainability and Patient Education

Efforts to enhance patient education and support are crucial for the market dynamics of QVAR 80. Healthcare professionals play a vital role in educating patients about proper inhaler usage, which not only improves treatment adherence but also enhances the overall effectiveness of the medication. Sustainability initiatives, including environmental considerations in device design and disposal, are also becoming increasingly important[1].

Technological Innovations

Technological innovations in inhaler devices are a key driver of market growth. The QVAR RediHaler, with its breath-actuated mechanism, represents a significant advancement in inhaler technology. Such innovations improve patient compliance and treatment outcomes, contributing to the market's overall growth[2].

Key Takeaways

• The inhaler corticosteroid device market, including QVAR 80, is projected to grow at a CAGR of 4.6% from 2024 to 2031.
• North America dominates the market due to high disease prevalence and advanced healthcare infrastructure.
• QVAR RediHaler has demonstrated efficacy and safety in clinical trials, improving lung function and reducing asthma symptoms.
• Regulatory approvals and technological innovations are key drivers of market growth.
• Patient education and sustainability initiatives are crucial for market dynamics.
• The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry, but Teva has maintained stable financial performance.

Frequently Asked Questions

Q: What is the projected market size of the inhaler corticosteroid device market by 2031? A: The market is expected to reach USD 886.4 million by 2031[1].

Q: What are the key factors driving the growth of QVAR 80 in the North American market? A: High prevalence of respiratory diseases, advanced healthcare infrastructure, and favorable reimbursement policies are key drivers[1].

Q: How has the COVID-19 pandemic affected the sales of QVAR 80? A: The pandemic led to a decrease in total script volume but Teva managed to maintain stable financial performance through cost savings[3].

Q: What are the main challenges facing the inhaler corticosteroid device market? A: High treatment costs, misuse of funding, lack of awareness, and patent expirations leading to generic competition are significant challenges[1].

Q: What role do technological innovations play in the market growth of QVAR 80? A: Technological innovations, such as the breath-actuated mechanism of QVAR RediHaler, improve patient compliance and treatment outcomes, contributing to market growth[2].

Cited Sources

1. Inhaler Corticosteroid Device Market 2024-2031 Analysis Report - InsightAce Analytic
2. 207921Orig1s000 - accessdata.fda.gov - FDA
3. Teva Pharmaceutical Industries Ltd. Q3 2020 Earnings Call - Teva Pharmaceutical Industries Ltd.
4. Teva Announces FDA Approval of QVAR® RediHaler - Teva Pharmaceuticals
5. Teva Reports Third Quarter 2019 Financial Results - Teva Pharmaceuticals