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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 sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy-four 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. Three 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 seven 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:	274
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
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
SGS S.A.	Phase 1
Chiesi Farmaceutici S.p.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	40 mcg/actuation	207921	1	2023-10-30

US Patents and Regulatory Information for QVAR REDIHALER

QVAR REDIHALER is protected by sixteen 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
Norton Waterford	QVAR REDIHALER	beclomethasone dipropionate	AEROSOL, METERED;INHALATION	207921-001	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

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	207921-002	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
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
Spain	2952686
South Korea	20160066563
Slovenia	2514467
European Patent Office	3517155	INHALATEUR ACTIONNÉ PAR LA RESPIRATION (BREATH ACTUATED INHALER)
Hong Kong	1222811

QVAR REDIHALER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for QVAR RediHaler

Introduction

QVAR RediHaler, a breath-actuated inhaler containing beclomethasone dipropionate, is a significant product in the asthma treatment market. Approved by the FDA in 2017, it offers a unique mode of delivery designed to simplify the administration of medication for patients with asthma. Here, we will delve into the market dynamics and financial trajectory of QVAR RediHaler.

Market Need and Target Audience

QVAR RediHaler addresses a critical need in the asthma management market. According to Dr. Warner W. Carr, MD, "approximately 76 percent of patients still struggle to use their MDI inhalers correctly, thus placing them at increased risk for asthma exacerbations"[4].

The product is intended for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. This broad target audience includes both pediatric and adult patients, making it a versatile treatment option.

Competitive Landscape

The asthma treatment market is highly competitive, with various inhalers and medications available. However, QVAR RediHaler stands out due to its breath-actuated design, which eliminates the need for hand-breath coordination during inhalation. This feature is particularly beneficial for patients who struggle with traditional metered-dose inhalers (MDIs)[4].

Generic Availability

As of the latest updates, there is no therapeutically equivalent generic version of QVAR RediHaler available in the United States. This lack of generic competition gives Teva Pharmaceuticals, the manufacturer, a market advantage[3].

Financial Performance

Revenue Growth

In the third quarter of 2019, QVAR revenues in Teva's North America segment increased by 68% to $60 million compared to the same period in 2018. This significant growth was part of the overall revenue mix that helped offset declines in other specialty products[2].

Segment Profitability

The North America segment, where QVAR RediHaler is a key product, saw a segment profit of $565 million in the third quarter of 2019, although this was a decrease from $649 million in the third quarter of 2018. The decrease was mainly due to lower revenues from other products, but higher revenues from QVAR, along with other products like AUSTEDO and AJOVY, helped mitigate this decline[2].

Cost and Expense Management

Teva's financial reports indicate that the company has been managing costs effectively. For instance, the decrease in non-GAAP financial expenses in the third quarter of 2019 was partly due to lower interest expenses resulting from debt prepayments and gains on hedging and derivatives activities. These cost reductions and efficiency measures have supported the profitability of segments including those where QVAR RediHaler is sold[2].

Product Launch and Market Impact

FDA Approval and Launch

QVAR RediHaler was approved by the FDA in August 2017 and became commercially available in the first quarter of 2018. The launch was part of Teva's strategy to replace the older QVAR MDI formulation with a more user-friendly and effective product[4].

Clinical Efficacy and Safety

The FDA approval was based on several clinical studies that demonstrated the efficacy and safety of QVAR RediHaler. These studies showed significant improvements in lung function and asthma control compared to placebo, supporting its market viability[5].

Market Reception and Patient Adoption

The unique design of QVAR RediHaler has been well-received by both patients and healthcare providers. The breath-actuated mechanism simplifies the inhalation process, reducing the risk of incorrect usage and improving patient compliance. This has contributed to its growing market share and positive financial performance.

Future Outlook

Market Expansion

Given the lack of generic competition and its clinical benefits, QVAR RediHaler is poised for continued growth. Teva's focus on innovative device technologies and patient-centric designs is likely to maintain its competitive edge in the asthma treatment market.

Regulatory Environment

The regulatory environment remains favorable, with the FDA approval providing a strong foundation for market presence. Continued compliance with regulatory standards and potential expansion into new markets or patient populations could further enhance its financial trajectory.

Challenges and Opportunities

Competition from Other Therapies

While QVAR RediHaler has a unique advantage, the asthma treatment market is dynamic, with new therapies and devices being developed. Staying ahead of the competition through continuous innovation and patient-centric solutions will be crucial.

Global Market Potential

Expanding into international markets could provide significant growth opportunities. However, this would require navigating different regulatory environments and market dynamics.

Key Takeaways

• Unique Market Position: QVAR RediHaler's breath-actuated design sets it apart in the asthma treatment market.
• Financial Growth: Significant revenue growth in North America segment driven by QVAR RediHaler.
• Clinical Efficacy: Strong clinical evidence supporting its effectiveness and safety.
• Regulatory Advantage: No generic competition currently available.
• Future Outlook: Potential for continued market expansion and growth.

FAQs

Q: What is QVAR RediHaler used for? A: QVAR RediHaler is used for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older.

Q: How does QVAR RediHaler differ from traditional MDIs? A: QVAR RediHaler is a breath-actuated inhaler, eliminating the need for hand-breath coordination during inhalation.

Q: Is there a generic version of QVAR RediHaler available? A: No, there is currently no therapeutically equivalent generic version of QVAR RediHaler available in the United States.

Q: What were the key financial highlights for QVAR RediHaler in 2019? A: QVAR revenues in Teva's North America segment increased by 68% to $60 million in the third quarter of 2019 compared to the same period in 2018.

Q: What are the potential future growth opportunities for QVAR RediHaler? A: Expanding into international markets and continuing innovation to stay ahead of competition are potential growth opportunities.

Sources

1. GlobalData: Net Present Value Model: Qvar - GlobalData
2. Teva Pharmaceuticals: Teva Reports Third Quarter 2019 Financial Results
3. Drugs.com: Generic Qvar RediHaler Availability - Drugs.com
4. Teva Pharmaceuticals: Teva Announces FDA Approval of QVAR® RediHaler™ (Beclomethasone Dipropionate HFA) Inhalation Aerosol
5. FDA: 207921Orig1s000 - accessdata.fda.gov