FLUNISOLIDE - Generic Drug Details

What are the generic sources for flunisolide and what is the scope of freedom to operate?

Flunisolide is the generic ingredient in five branded drugs marketed by Roche Palo, Norvium Bioscience, Apotex, Bausch, Riconpharma Llc, Rising, Ivax Res, and Teva Branded Pharm, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for flunisolide. Two suppliers are listed for this compound.

Summary for FLUNISOLIDE

US Patents:	0
Tradenames:	5
Applicants:	8
NDAs:	8
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	4
Patent Applications:	7,259
Drug Prices:	Drug price trends for FLUNISOLIDE
Drug Sales Revenues:	Drug sales revenues for FLUNISOLIDE
What excipients (inactive ingredients) are in FLUNISOLIDE?	FLUNISOLIDE excipients list
DailyMed Link:	FLUNISOLIDE at DailyMed

See drug prices for FLUNISOLIDE

See drug sales revenues for FLUNISOLIDE

Recent Clinical Trials for FLUNISOLIDE

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

Sponsor	Phase
University of Louisville	N/A
Meda Pharmaceuticals	N/A
GlaxoSmithKline	Phase 3

See all FLUNISOLIDE clinical trials

Pharmacology for FLUNISOLIDE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for FLUNISOLIDE

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for FLUNISOLIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	FLUNISOLIDE	flunisolide	SPRAY, METERED;NASAL	074805-001	Feb 20, 2002	AB	RX	No	Yes
Riconpharma Llc	FLUNISOLIDE	flunisolide	SPRAY, METERED;NASAL	207802-001	Jun 16, 2022	AB	RX	No	No
Roche Palo	AEROBID	flunisolide	AEROSOL, METERED;INHALATION	018340-001	Aug 17, 1984		DISCN	No	No
Ivax Res	NASALIDE	flunisolide	SPRAY, METERED;NASAL	018148-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for FLUNISOLIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	NASAREL	flunisolide	SPRAY, METERED;NASAL	020409-001	Mar 8, 1995	4,782,047
Roche Palo	AEROBID	flunisolide	AEROSOL, METERED;INHALATION	018340-001	Aug 17, 1984	4,933,168
Teva Branded Pharm	NASAREL	flunisolide	SPRAY, METERED;NASAL	020409-001	Mar 8, 1995	4,983,595
Teva Branded Pharm	NASAREL	flunisolide	SPRAY, METERED;NASAL	020409-001	Mar 8, 1995	4,933,168

FLUNISOLIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Flunisolide

Introduction to Flunisolide

Flunisolide is a synthetic corticosteroid used primarily in the treatment of allergic rhinitis and asthma. It is available in various forms, including nasal sprays and inhalers. Understanding the market dynamics and financial trajectory of flunisolide is crucial for manufacturers, investors, and healthcare professionals.

Market Size and Growth

The global flunisolide market has been experiencing steady growth driven by increasing demand for effective treatments for respiratory conditions. As of the latest reports, the market is segmented by type and application.

• By Type: The market is categorized based on purity levels, such as 98% and 99% purity flunisolide[4].
• By Application: The primary applications include allergic rhinitis, asthma, and other respiratory conditions[4].

The market size is expected to grow significantly over the forecast period, driven by factors such as the rising incidence of respiratory problems and advancements in medical technology.

Key Players and Competitive Landscape

The flunisolide market is highly competitive, with several key players dominating the landscape.

• Main Players: Active Biopharma Corp, MCE (MedChemExpress), Merck, Toronto Research Chemicals (TRC), MedChemExpress, Alfa Aesar, CAYMAN, SynFine Research, TCI Europe, Axon Medchem BV, ABCR, and Service Chemical Inc are among the major manufacturers[4].
• Competitive Analysis: The competitive analysis helps players to improve their business strategies and identify opportunities in different regions. The report provides insights into market share, CAGR, and revenue growth for each segment and region[1].

Market Drivers and Trends

Several factors are driving the growth of the flunisolide market:

• Increasing Incidence of Respiratory Problems: The rising prevalence of allergic rhinitis and asthma is a significant driver. As the global population faces more air pollution and other environmental factors, the demand for effective treatments is increasing[3].
• Technological Advancements: Improvements in inhaler technology and the development of more efficient delivery systems are enhancing the market. New formulations and delivery methods are making flunisolide more accessible and effective[3].
• Regulatory Environment: Regulatory bodies play a crucial role in ensuring that drug prices are not excessive. For instance, the Patented Medicine Prices Review Board (PMPRB) in Canada ensures that patented drug prices, including those of flunisolide, are reasonable[2].

Regional Market Analysis

The flunisolide market is analyzed across various regions, including North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

• North America: This region has a significant market share due to high healthcare spending and advanced medical infrastructure. The market in North America is expected to grow steadily, driven by the increasing incidence of respiratory diseases[1].
• Europe: Europe also holds a substantial share, with countries like the UK, Germany, and France contributing significantly to the market. The region's stringent regulatory environment and high healthcare standards drive the demand for flunisolide[1].
• Asia-Pacific: This 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[1].

Financial Trajectory

The financial performance of the flunisolide market is robust and expected to continue growing.

• Revenue Forecast: The market is forecasted to grow in terms of both value and volume. The revenue is expected to increase significantly over the forecast period, driven by the increasing demand and expanding applications[1][4].
• 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[1].
• Pricing and Revenue: The pricing of flunisolide 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[2].

Challenges and Restraints

Despite the growth, the flunisolide market faces several challenges:

• Regulatory Hurdles: Strict regulatory environments can impact the pricing and availability of flunisolide. For example, the PMPRB in Canada ensures that drug prices are reasonable, which can affect the revenue of manufacturers[2].
• Competition: The market 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[1].

Opportunities

There are several opportunities for growth in the flunisolide market:

• Emerging Markets: Regions like Asia-Pacific offer significant growth opportunities due to the large population and increasing healthcare spending[1].
• Technological Innovations: Advancements in delivery systems and formulations can enhance the efficacy and accessibility of flunisolide, opening up new market opportunities[3].

Key Takeaways

• The flunisolide market is driven by the increasing incidence of respiratory problems and technological advancements.
• Key players include Active Biopharma Corp, MCE (MedChemExpress), and Merck, among others.
• The market is segmented by type (purity levels) and application (allergic rhinitis, asthma).
• Regional analysis shows significant growth potential in North America, Europe, and Asia-Pacific.
• Regulatory environments play a crucial role in pricing and revenue.
• Emerging markets and technological innovations offer future growth opportunities.

Frequently Asked Questions

Q: What is the expected growth rate of the flunisolide market? A: The exact growth rate can vary, but the market is expected to grow steadily driven by increasing demand and technological advancements.

Q: Who are the main players in the flunisolide market? A: The main players include Active Biopharma Corp, MCE (MedChemExpress), Merck, Toronto Research Chemicals (TRC), and others.

Q: What are the primary applications of flunisolide? A: The primary applications include allergic rhinitis, asthma, and other respiratory conditions.

Q: How does the regulatory environment impact the flunisolide market? 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 flunisolide market? A: North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa are the key regions, with Asia-Pacific showing rapid growth potential.

Cited Sources

1. OpenPR: Flunisolide Market Size, Analytical Overview, Growth Factors, Demand, Trends and Forecast to 2029.
2. Publications.gc.ca: Patented Medicine Prices Review Board.
3. Business Research Insights: Fluticasone Propionate Inhalers Market Size, Share & Report, 2032.
4. Valuates Reports: Global Flunisolide Market Research Report 2024.