AEROSPAN HFA Drug Patent Profile

When do Aerospan Hfa patents expire, and what generic alternatives are available?

Aerospan Hfa is a drug marketed by Norvium Bioscience and is included in one NDA.

The generic ingredient in AEROSPAN HFA is flunisolide. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the flunisolide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aerospan Hfa

A generic version of AEROSPAN HFA was approved as flunisolide by BAUSCH on February 20^th, 2002.

Summary for AEROSPAN HFA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	48
Patent Applications:	4,991
DailyMed Link:	AEROSPAN HFA at DailyMed

US Patents and Regulatory Information for AEROSPAN HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	AEROSPAN HFA	flunisolide	AEROSOL, METERED;INHALATION	021247-001	Jan 27, 2006		DISCN	Yes	No

Expired US Patents for AEROSPAN HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	AEROSPAN HFA	flunisolide	AEROSOL, METERED;INHALATION	021247-001	Jan 27, 2006
Norvium Bioscience	AEROSPAN HFA	flunisolide	AEROSOL, METERED;INHALATION	021247-001	Jan 27, 2006

International Patents for AEROSPAN HFA

See the table below for patents covering AEROSPAN HFA around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2145254
Australia	680967
Denmark	0735884

AEROSPAN HFA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Aerospan HFA

Introduction

Aerospan HFA, a metered-dose inhaler (MDI) containing flunisolide, is a crucial medication for the treatment of asthma in adult and pediatric patients. To understand its market dynamics and financial trajectory, it is essential to delve into various factors influencing its demand, competition, and regulatory environment.

Increasing Incidence of Respiratory Problems

The rising prevalence of respiratory diseases such as asthma and allergic rhinitis is a significant driver for the demand of Aerospan HFA. As the global population faces increasing air pollution and other environmental factors, the need for effective treatments like flunisolide is on the rise[3].

Technological Advancements

Improvements in inhaler technology and the development of more efficient delivery systems are enhancing the market for Aerospan HFA. The unique feature of Aerospan, which includes a built-in inhalation chamber (spacer), assists in the delivery of the medicine to the lungs, making it more effective and user-friendly[2].

Regulatory Environment

Regulatory bodies play a crucial role in the market dynamics of Aerospan HFA. For instance, the U.S. Food and Drug Administration (FDA) has approved Aerospan for the treatment of asthma, and regulatory bodies ensure that drug prices are not excessive. This can impact the pricing and revenue strategies of manufacturers[3].

Market Size and Growth

The flunisolide market, which includes Aerospan HFA, is expected to grow steadily. The market size is driven by increasing demand and technological advancements. In the United States, the sales of MDIs, including those containing flunisolide, have shown significant growth. From 2015 to 2020, the sales of MDIs increased by 75%, from 80 million units to 140 million units[1].

Regional Market Analysis

North America

North America has a significant market share for Aerospan HFA due to high healthcare spending and advanced medical infrastructure. The region is expected to continue growing, driven by the increasing incidence of respiratory diseases[3].

Europe

Europe also holds a substantial share of the market, with countries like the UK, Germany, and France contributing significantly. The region's stringent regulatory environment and high healthcare standards drive the demand for flunisolide-based products[3].

Asia-Pacific

The Asia-Pacific region is expected to show rapid growth due to the large population and increasing awareness of respiratory health. Countries like China and India are emerging as key markets for flunisolide and other respiratory medications[3].

Financial Trajectory

Revenue Forecast

The revenue from the flunisolide market, including Aerospan HFA, is forecasted to increase significantly over the forecast period. This growth is driven by the increasing demand and expanding applications of flunisolide[3].

Sales Breakdown

The sales breakdown by type and application provides a detailed insight into the market's financial performance. For instance, the sales of flunisolide for allergic rhinitis and asthma are significant contributors to the overall revenue[3].

Pricing and Revenue

The pricing of Aerospan HFA is influenced by regulatory bodies to ensure it is not excessive. The revenue growth is also affected by the competitive landscape, with top players competing to maintain market share. The acquisition of Acton Pharmaceuticals by Meda, which included Aerospan, highlighted the strategic importance of this product in the respiratory market[2].

Challenges and Restraints

Regulatory Hurdles

Strict regulatory environments can impact the pricing and availability of Aerospan HFA. For example, regulatory bodies like the Patented Medicine Prices Review Board (PMPRB) in Canada ensure that drug prices are reasonable, which can affect the revenue of manufacturers[3].

Competition

The market for MDIs is highly competitive, with many players vying for market share. This competition can lead to pricing pressures and affect the financial performance of individual companies. However, the unique features of Aerospan, such as its built-in inhalation chamber, provide a competitive edge[2].

Opportunities

Emerging Markets

Regions like Asia-Pacific offer significant growth opportunities due to the large population and increasing healthcare spending. Expanding into these markets can enhance the revenue and market share of Aerospan HFA[3].

Technological Innovations

Advancements in delivery systems and formulations can enhance the efficacy and accessibility of flunisolide, opening up new market opportunities. For instance, the potential replacement of HFC propellants with more environmentally friendly options like HFO-1234ze(E) and HFC-152a could further boost the market[1][4].

Key Players

The market for Aerospan HFA includes several key players. Meda AB, which acquired Acton Pharmaceuticals, is a significant player in the respiratory market. Other key players include Active Biopharma Corp, MCE (MedChemExpress), and Merck[2][3].

Projected Sales and HFC Propellant Use

The projected sales of HFC MDIs, including those containing flunisolide, are expected to grow at a rate of approximately 1% per year through 2025. The amount of HFC propellant in MDIs sold in the United States is estimated to grow to approximately 1,556 MT in 2025, with HFC-134a and HFC-227ea being the primary propellants[1][4].

Conclusion

The market dynamics and financial trajectory for Aerospan HFA are driven by several key factors, including the increasing incidence of respiratory problems, technological advancements, and a favorable regulatory environment. Despite challenges such as regulatory hurdles and competition, the market is expected to grow steadily, with significant opportunities in emerging markets and through technological innovations.

Key Takeaways

• The market for Aerospan HFA is driven by the increasing incidence of respiratory diseases and technological advancements.
• Regulatory bodies play a crucial role in pricing and revenue strategies.
• North America, Europe, and Asia-Pacific are key regions for the market.
• Emerging markets and technological innovations offer future growth opportunities.
• The market is highly competitive, with key players including Meda AB, Active Biopharma Corp, and Merck.

Frequently Asked Questions

Q: What is Aerospan HFA used for? A: Aerospan HFA is used for the treatment of asthma in adult and pediatric patients 6 years of age and older.

Q: What are the unique features of Aerospan HFA? A: Aerospan HFA has a built-in inhalation chamber (spacer) which assists in the delivery of the medicine to the lungs.

Q: How does the regulatory environment impact Aerospan HFA? A: Regulatory bodies ensure that drug prices are not excessive, which can affect the revenue and pricing strategies of manufacturers.

Q: What are the key regions for the Aerospan HFA market? A: North America, Europe, and Asia-Pacific are the key regions, with Asia-Pacific showing rapid growth potential.

Q: What are the challenges faced by the Aerospan HFA market? A: The market faces challenges such as regulatory hurdles and competition from other respiratory medications.

Cited Sources

1. EPA: Market Characterization of the U.S. Metered Dose Inhaler Industry[1].
2. Business Wire: MEDA: Acquisition of Acton Pharmaceuticals Completed[2].
3. Drug Patent Watch: Generic FLUNISOLIDE INN equivalents, drug patent expiry and market dynamics[3].
4. EPA: Market Characterization of the U.S. Metered Dose Inhaler Industry[4].