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Last Updated: December 22, 2024

MEDIHALER-EPI Drug Patent Profile


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Which patents cover Medihaler-epi, and when can generic versions of Medihaler-epi launch?

Medihaler-epi is a drug marketed by 3M and is included in one NDA.

The generic ingredient in MEDIHALER-EPI is epinephrine bitartrate. There are twenty-one drug master file entries for this compound. Additional details are available on the epinephrine bitartrate profile page.

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Summary for MEDIHALER-EPI
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 79
DailyMed Link:MEDIHALER-EPI at DailyMed
Drug patent expirations by year for MEDIHALER-EPI

US Patents and Regulatory Information for MEDIHALER-EPI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
3m MEDIHALER-EPI epinephrine bitartrate AEROSOL, METERED;INHALATION 010374-003 Approved Prior to Jan 1, 1982 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

MEDIHALER-EPI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epinephrine Auto-Injectors: A Focus on MEDIHALER-EPI

Introduction

The global epinephrine market, which includes products like MEDIHALER-EPI, is experiencing significant growth driven by several key factors. This article will delve into the market dynamics, financial trajectory, and the specific context of epinephrine auto-injectors, particularly highlighting the trends and opportunities in this sector.

Increasing Prevalence of Anaphylaxis

The rising incidence of anaphylaxis, a severe and potentially life-threatening allergic reaction, is a major driver of the epinephrine market. Anaphylaxis can occur suddenly after exposure to allergens such as food, insect stings, or medicines, and its lifetime prevalence is estimated to be between 0.05% and 3% globally[1].

Growing Adoption of Epinephrine Auto-Injectors

There is a growing trend towards the adoption of reusable and prefilled epinephrine auto-injectors. These devices are designed to be easy to use, providing step-by-step instructions during an allergic reaction, which reduces delays in administration during emergency conditions. This ease of use and the critical nature of the treatment have led to auto-injectors holding over 70% of the market share in the epinephrine market[1].

New Product Approvals and Launches

Market players are continuously innovating and launching new products with improved features. For instance, the FDA approval of ANTARES, a prefilled epinephrine auto-injector with an extended shelf-life, in August 2020, highlights the industry's focus on enhancing product quality and usability[1].

Market Opportunities

Increasing Incidence of Anaphylaxis

The increasing prevalence of allergies and the rising incidence of anaphylaxis are expected to drive the demand for epinephrine auto-injectors. Anaphylaxis affects 1-5% of the population, and its incidence has increased significantly over the past few decades. Auto-injectors are now considered the standard of care for treating anaphylaxis due to their ease of use and effectiveness[1].

Investments in Technology Advancements

Epinephrine delivery devices are advancing with new technologies that enhance safety, accuracy, and ease of use. Innovations such as wearable and hands-free epinephrine auto-injectors, Bluetooth and audio guidance features, and reusable auto-injectors that can administer multiple consistent doses are expected to improve treatment outcomes and compliance for patients at risk of anaphylaxis[1].

Financial Trajectory

Market Size and Growth

The global epinephrine market is anticipated to witness a Compound Annual Growth Rate (CAGR) of 11.6% during the forecast period from 2024 to 2031. The market is expected to grow from $2.91 billion in 2023 to $6.27 billion by 2031, driven by the rising prevalence of environmental and food allergies globally[1].

Revenue Forecast

By product type, the auto-injectors segment is expected to dominate the market, accounting for over 70% of the market share. The anaphylaxis segment is expected to dominate the application segment with over 80% share, as epinephrine is the first-line treatment for anaphylaxis. The hospital pharmacy segment is expected to hold the major share in terms of distribution channels due to higher patient footfall, insurance coverage, and critical conditions treated[1].

Regional Dominance

North America is expected to hold a dominant position in the epinephrine market over the forecast period, driven by high awareness about anaphylaxis, supportive reimbursement policies, and the presence of leading players. Europe is also expected to grow at a significant rate[1].

Competitive Landscape

Key players in the epinephrine market include Pfizer, Mylan Inc., Sanofi S.A, and ALK-Abello. These companies are actively involved in launching innovative products and expanding their market presence through strategic initiatives[1].

Recent Developments

In 2023, Daiichi Sankyo’s subsidiary, American Regent, launched a sulfite-free epinephrine injection, providing a safer option for patients allergic to sulfites. Such launches indicate the industry's commitment to improving product safety and efficacy[1].

Challenges and Limitations

High Treatment Costs

Despite the growing demand, high treatment costs remain a significant barrier to the widespread adoption of epinephrine auto-injectors. This can limit access to these life-saving devices, especially in regions with limited healthcare resources[1].

Product Recalls

The market has also faced challenges due to product recalls, which can impact consumer confidence and market growth. Ensuring product quality and reliability is crucial for maintaining market trust and driving continued growth[1].

Technological Innovations

The integration of advanced technologies such as Bluetooth and audio guidance in epinephrine auto-injectors is enhancing user experience and treatment outcomes. Wearable and hands-free devices are also being developed to administer doses through clothing, further simplifying the treatment process[1].

Regulatory Environment

Regulatory approvals and guidelines play a critical role in the epinephrine market. For instance, the FDA's approval of new products and the ongoing research into safer propellants and delivery mechanisms are key factors influencing market dynamics[4].

Public Health Impact

The public health sector's proactive approach to enhancing asthma and allergy care is also relevant to the epinephrine market. Increased funding and support for programs aimed at reducing emergency visits and hospitalizations due to allergic reactions can indirectly boost the demand for epinephrine auto-injectors[3].

Key Takeaways

  • The global epinephrine market is expected to grow at a CAGR of 11.6% from 2024 to 2031.
  • Auto-injectors will dominate the market due to their ease of use and effectiveness.
  • The anaphylaxis segment will drive the majority of the demand.
  • North America will lead the market due to high awareness and supportive policies.
  • Technological advancements and new product launches are key growth drivers.
  • High treatment costs and product recalls are significant challenges.

FAQs

What is driving the growth of the epinephrine market?

The growth of the epinephrine market is primarily driven by the increasing prevalence of anaphylaxis reactions globally and the growing adoption of epinephrine auto-injectors.

Which segment is expected to dominate the epinephrine market?

The auto-injectors segment is expected to hold over 70% of the market share due to their ease of use and effectiveness in treating anaphylaxis.

What are the key technological advancements in epinephrine delivery devices?

Technological advancements include the development of wearable and hands-free epinephrine auto-injectors, Bluetooth and audio guidance features, and reusable auto-injectors that can administer multiple consistent doses.

Which region is expected to lead the epinephrine market?

North America is expected to hold a dominant position in the epinephrine market due to high awareness about anaphylaxis, supportive reimbursement policies, and the presence of leading players.

What are the challenges facing the epinephrine market?

High treatment costs and product recalls are significant challenges facing the epinephrine market, which can limit access and impact consumer confidence.

Sources:

  1. Coherent Market Insights, "Epinephrine Market to Hit USD 6.27 Billion by 2031, Says Coherent Market Insights," October 28, 2024.
  2. PR Newswire, "Insmed Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides Business Update," February 22, 2024.
  3. Biospace, "U.S. Asthma Drugs Market Size to Surpass USD 14.75 Bn by 2033," May 24, 2024.
  4. EPA, "Market Characterization of the U.S. Metered Dose Inhaler Industry," 2021.

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