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Last Updated: December 22, 2024

Beclomethasone dipropionate monohydrate - Generic Drug Details


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What are the generic sources for beclomethasone dipropionate monohydrate and what is the scope of freedom to operate?

Beclomethasone dipropionate monohydrate is the generic ingredient in two branded drugs marketed by Glaxosmithkline and Schering, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for beclomethasone dipropionate monohydrate. One supplier is listed for this compound.

Summary for beclomethasone dipropionate monohydrate
US Patents:0
Tradenames:2
Applicants:2
NDAs:3
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 10
Patent Applications: 437
What excipients (inactive ingredients) are in beclomethasone dipropionate monohydrate?beclomethasone dipropionate monohydrate excipients list
DailyMed Link:beclomethasone dipropionate monohydrate at DailyMed
Pharmacology for beclomethasone dipropionate monohydrate

US Patents and Regulatory Information for beclomethasone dipropionate monohydrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline BECONASE AQ beclomethasone dipropionate monohydrate SPRAY, METERED;NASAL 019389-001 Jul 27, 1987 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Schering VANCENASE AQ beclomethasone dipropionate monohydrate SPRAY, METERED;NASAL 020469-001 Jun 26, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Schering VANCENASE AQ beclomethasone dipropionate monohydrate SPRAY, METERED;NASAL 019589-001 Dec 23, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Beclomethasone dipropionate monohydrate Market Analysis and Financial Projection Experimental

Beclomethasone Dipropionate Monohydrate: Market Dynamics and Financial Trajectory

Introduction to Beclomethasone Dipropionate Monohydrate

Beclomethasone dipropionate monohydrate is a synthetic corticosteroid widely used to treat inflammatory conditions such as asthma, allergic rhinitis, and other respiratory allergies. Its efficacy in controlling symptoms like sneezing, shortness of breath, and nasal congestion has made it a staple in the pharmaceutical industry.

Market Size and Forecast

The beclomethasone dipropionate market is experiencing significant growth, driven by several key factors. The market size is projected to increase substantially from 2021 to 2031, with a moderate to high growth rate. This upward trend is largely attributed to the increasing global population and the rising number of asthma and allergic rhinitis patients[1][4][5].

Key Drivers of Market Growth

Increasing Prevalence of Asthma and Allergic Rhinitis

The global increase in asthma and allergic rhinitis cases, particularly in industrial areas, is a primary driver of the market. As more people are affected by these conditions, the demand for beclomethasone dipropionate is expected to rise[1].

Advancements in Technology and R&D

Pharmaceutical companies are investing heavily in research and development to improve the formulations and delivery methods of beclomethasone dipropionate. This includes the development of more effective inhalation devices and other administration routes, which is further boosting market growth[1].

Changing Lifestyle and Disposable Income

The increase in disposable income and changes in lifestyle have led to greater healthcare spending, contributing to the market's expansion. Consumers are more willing to invest in effective treatments for chronic conditions like asthma and allergic rhinitis[1].

Market Segmentation

By Application

The market is segmented into several applications, with asthma and allergic rhinitis being the primary segments. The asthma segment holds a significant share due to the high prevalence of the condition globally[1][4].

  • Asthma: This segment accounts for a large portion of the market due to the increasing number of asthma patients worldwide.
  • Allergic Rhinitis: This segment is also growing as more people are affected by allergic reactions.
  • Others: This includes other respiratory and inflammatory conditions where beclomethasone dipropionate is used.

By Administration Route

The drug is available in various formulations, each catering to different needs:

  • Inhalation: This is one of the most common routes, especially for asthma patients.
  • Oral: Used for systemic effects or when inhalation is not feasible.
  • Injection: Less common but used in severe cases or specific conditions[1].

By Geography

The global market is segmented geographically into:

  • North America: This region holds a significant share due to the high demand for the drug in the U.S., Canada, and Mexico.
  • Europe: Countries like Germany, the U.K., and France contribute substantially to the market.
  • Asia Pacific: This region is growing rapidly, with countries like China, Japan, and India showing increased demand.
  • Rest of the World: Includes Latin America, Middle East & Africa, and other regions[1][5].

Competitive Landscape

The beclomethasone dipropionate market is highly competitive, with several key players:

  • AMRI: Known for its extensive research and development capabilities.
  • Avik Pharmaceutical Ltd.: Focuses on producing high-quality pharmaceuticals.
  • Anuh Pharma Ltd: Specializes in manufacturing a range of pharmaceutical products.
  • Cipla Inc.: A major player in the global pharmaceutical market.
  • Teva Pharmaceutical Industries Ltd.: A leading generic and specialty pharmaceutical company[1].

These companies are engaged in various strategies such as product innovation, mergers and acquisitions, and expansion into new markets to maintain their market share.

Financial Performance and Trends

The financial trajectory of the beclomethasone dipropionate market is positive, with projected revenue growth from 2021 to 2031. Here are some key financial trends:

  • Revenue Growth: The market is expected to grow significantly, with a compound annual growth rate (CAGR) that reflects the increasing demand for the drug[5].
  • Investment in R&D: Pharmaceutical companies are investing heavily in research and development to improve formulations and delivery methods, which is driving market growth[1].
  • Market Size: The market size is estimated to be in the millions of USD, with projections indicating continued growth over the forecast period[4][5].

Challenges and Restraints

Despite the positive growth trajectory, there are several challenges that the market faces:

  • Side Effects: Beclomethasone dipropionate comes with several side effects, which can act as a barrier to market growth. These include local and systemic side effects such as oral thrush, hoarseness, and adrenal suppression[1].
  • Regulatory Compliance: Pharmaceutical companies must comply with stringent regulatory requirements, which can sometimes slow down market growth. For instance, the Patented Medicine Prices Review Board (PMPRB) in Canada ensures that drug prices are not excessive, which can impact revenue[2].

Technological and Regulatory Trends

Technological Advancements

Technological advancements in drug delivery systems, such as improved inhalation devices and nasal sprays, are enhancing the efficacy and patient compliance of beclomethasone dipropionate. These innovations are expected to continue driving market growth[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics. Regulatory bodies ensure that drugs are safe and effective, and compliance with these regulations is essential for market success. For example, the PMPRB in Canada has been active in ensuring that drug prices are reasonable and that companies comply with voluntary compliance undertakings[2].

Consumer Behavior and Market Insights

Consumer behavior is a critical factor in the market dynamics of beclomethasone dipropionate. Patients are increasingly seeking effective and convenient treatments for chronic conditions like asthma and allergic rhinitis. The demand for inhalation devices and other user-friendly formulations is on the rise, driving companies to innovate and expand their product lines[5].

Key Takeaways

  • Growing Demand: The increasing prevalence of asthma and allergic rhinitis is driving the demand for beclomethasone dipropionate.
  • Technological Advancements: Improvements in drug delivery systems are enhancing the market.
  • Competitive Landscape: The market is highly competitive with several key players investing in R&D and market expansion.
  • Financial Growth: The market is projected to grow significantly over the forecast period.
  • Challenges: Side effects and regulatory compliance are key challenges that the market faces.

FAQs

What are the primary applications of beclomethasone dipropionate?

The primary applications of beclomethasone dipropionate are in treating asthma and allergic rhinitis, with other respiratory and inflammatory conditions also being treated with this drug[1][4].

Which regions are the largest markets for beclomethasone dipropionate?

North America, Europe, and the Asia Pacific are the largest markets for beclomethasone dipropionate, driven by high demand and increasing prevalence of respiratory conditions[1][5].

What are the common administration routes for beclomethasone dipropionate?

The common administration routes include inhalation, oral, and injection, with inhalation being the most common for asthma patients[1].

Who are the key players in the beclomethasone dipropionate market?

Key players include AMRI, Avik Pharmaceutical Ltd., Anuh Pharma Ltd, Cipla Inc., and Teva Pharmaceutical Industries Ltd.[1].

What are the major challenges facing the beclomethasone dipropionate market?

The major challenges include side effects associated with the drug and regulatory compliance requirements that pharmaceutical companies must adhere to[1][2].

Sources

  1. Verified Market Research: Beclomethasone Dipropionate Market Size, Share, Trends & Forecast.
  2. Patented Medicine Prices Review Board: Annual Report 2016.
  3. Pharmacompass: Beclomethasone Dipropionate API Manufacturers | Suppliers.
  4. Market Research Intellect: Beclomethasone Dipropionate Market Size And Forecast.
  5. Cognitive Market Research: Beclomethasone Dipropionate Market Report 2024 (Global Edition).

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