QVAR 40 Drug Patent Profile

When do Qvar 40 patents expire, and when can generic versions of Qvar 40 launch?

Qvar 40 is a drug marketed by Teva Branded Pharm and is included in one NDA. There are eight patents protecting this drug.

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

The generic ingredient in QVAR 40 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 40

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 18, 2031. This may change due to patent challenges or generic licensing.

There have been eight 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 40

International Patents:	192
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	65
Patent Applications:	4,697
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for QVAR 40
DailyMed Link:	QVAR 40 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QVAR 40

NDA:

020911

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.

US Patents and Regulatory Information for QVAR 40

QVAR 40 is protected by eight 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	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No			Y
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No			Y
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No			Y
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No			Y
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No			Y
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No			Y
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000		DISCN	Yes	No			Y

Expired US Patents for QVAR 40

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000
Teva Branded Pharm	QVAR 40	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	020911-002	Sep 15, 2000

International Patents for QVAR 40

When does loss-of-exclusivity occur for QVAR 40?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

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 40 around the world.

Country	Patent Number	Title	Estimated Expiration
United Kingdom	8828477
Spain	2222525
South Korea	20160066563
Slovenia	2514467
Hong Kong	1222811
Hungary	E029937
Japan	H06501710

QVAR 40 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for QVAR 40

Overview of QVAR 40

QVAR 40, containing the active ingredient beclomethasone dipropionate, is an anti-inflammatory, synthetic corticosteroid used for the prophylactic management of mild, moderate, or severe asthma. It is formulated as a metered or pressurized aerosol spray for inhalation[3].

Market Size and Growth

The inhaler corticosteroid device market, which includes products like QVAR 40, 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 Compound Annual Growth Rate (CAGR) of 4.6% during the forecast period of 2024-2031[1].

Revenue and Financial Performance

Historically, QVAR has shown fluctuating revenue trends. For instance, in the third quarter of 2019, QVAR revenues in Teva's North America segment increased by 68% to $60 million compared to the same quarter in 2018. However, in the fourth quarter of 2020, QVAR revenues decreased to $40 million compared to the fourth quarter of 2019[2][5].

Competitive Landscape

The competitive landscape of the inhaler corticosteroid market is dynamic, with several key players. The market is influenced by factors such as patent expirations, which can lead to generic competition and impact pricing and market share. Companies like Teva, the manufacturer of QVAR, are focusing on partnerships to accelerate innovation and market penetration[1].

Regulatory Updates and Sustainability

Regulatory updates play a crucial role in the market dynamics of QVAR 40. Emphasis on safety, efficacy, and environmental sustainability is increasing. For example, regulatory bodies are pushing for more sustainable packaging and production processes, which can affect the overall cost and market positioning of the product[1].

Patient Education and Support

Patient education and support are vital components of the market strategy for QVAR 40. Companies are investing in initiatives that educate patients about the proper use of inhalers and the importance of adherence to treatment plans. This not only improves patient outcomes but also enhances market loyalty and retention[1].

Impact of COVID-19

The COVID-19 pandemic has posed significant challenges to the pharmaceutical industry, including the inhaler corticosteroid market. Despite these challenges, ongoing research and development efforts have continued to drive market evolution. The pandemic has also highlighted the importance of respiratory health, potentially increasing demand for products like QVAR 40[1].

Patent and Generic Competition

The patent status of QVAR 40 is a critical factor in its market dynamics. As patents expire, generic versions of the drug can enter the market, leading to increased competition and potential price reductions. For instance, the QVAR RediHaler, a breath-actuated inhaler, faces indicators of generic entry which could impact its market share and pricing[4].

Net Present Value (NPV) Model

Evaluating the financial trajectory of QVAR 40 involves complex models such as the Net Present Value (NPV) model. This model, provided by GlobalData, includes forecasts of revenue, operating profit, net profit, and discounted cash flow to derive the NPV of the drug. It takes into account factors like patent law, regulatory approval processes, cash flows, and pricing estimates[3].

Regional Market Performance

The market performance of QVAR 40 varies by region. North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa are key regions where the product is marketed. For example, QVAR revenues have shown significant growth in North America in the past, but regional performance can fluctuate based on local market conditions and competition[1].

Key Manufacturers and Partnerships

Teva Pharmaceuticals is the primary manufacturer of QVAR 40. The company's financial performance, including revenues, gross profit, and research & development expenses, directly impacts the market dynamics of the product. Partnerships and collaborations with other companies are also crucial for accelerating innovation and market penetration[2][5].

Challenges and Opportunities

Despite the growth potential, the market for QVAR 40 faces challenges such as high treatment costs, misuse of funding, and lack of awareness. Addressing these challenges through patient education, cost-effective strategies, and regulatory compliance can open up new opportunities for market expansion[1].

Sustainability Initiatives

Sustainability initiatives are becoming increasingly important in the pharmaceutical industry. Companies are focusing on environmentally sustainable practices, which can enhance their market image and comply with regulatory requirements. This includes sustainable packaging, reduced waste, and eco-friendly production processes[1].

Conclusion

The market dynamics and financial trajectory of QVAR 40 are influenced by a combination of factors including regulatory updates, patient education, patent expirations, and sustainability initiatives. As the inhaler corticosteroid device market continues to grow, addressing challenges and leveraging opportunities will be crucial for maintaining market dominance.

Key Takeaways

• The inhaler corticosteroid device market is projected to grow at a CAGR of 4.6% from 2024 to 2031.
• QVAR 40 faces competition from generic versions as patents expire.
• Regulatory updates emphasize safety, efficacy, and environmental sustainability.
• Patient education and support are critical for market success.
• Sustainability initiatives are increasingly important.
• Regional market performance varies, with North America being a significant market.

FAQs

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

Q: How has the revenue of QVAR 40 fluctuated in recent years? A: QVAR revenues increased by 68% in the third quarter of 2019 but decreased to $40 million in the fourth quarter of 2020 compared to the previous year[2][5].

Q: What are the key factors influencing the market dynamics of QVAR 40? A: Key factors include regulatory updates, patent expirations, patient education, and sustainability initiatives[1].

Q: How does the Net Present Value (NPV) model help in evaluating QVAR 40? A: The NPV model provides a comprehensive evaluation of the drug's financial trajectory, including revenue forecasts, operating profit, and discounted cash flow[3].

Q: What are the main regions where QVAR 40 is marketed? A: Key regions include North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa[1].

Sources

1. Inhaler Corticosteroid Device Market 2024-2031 Analysis Report - InsightAce Analytic
2. Teva Reports Third Quarter 2019 Financial Results - Teva Pharmaceuticals
3. Net Present Value Model: Qvar - GlobalData
4. QVAR REDIHALER Drug Patent Profile - Drug Patent Watch
5. Teva Reports Fourth Quarter and Full Year 2020 Financial Results - Teva Pharmaceuticals