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Last Updated: December 22, 2024

Epinephrine bitartrate - Generic Drug Details


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What are the generic drug sources for epinephrine bitartrate and what is the scope of freedom to operate?

Epinephrine bitartrate is the generic ingredient in eight branded drugs marketed by Wyeth Cons, 3M, Astrazeneca, Dentsply Pharm, Deproco, and Septodont Inc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for epinephrine bitartrate.

Summary for epinephrine bitartrate
Recent Clinical Trials for epinephrine bitartrate

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

SponsorPhase
De Motu CordisPhase 1
Novotech (Australia) Pty LimitedPhase 1
Sunnybrook Health Sciences CentreN/A

See all epinephrine bitartrate clinical trials

US Patents and Regulatory Information for epinephrine bitartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 017751-007 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dentsply Pharm DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 021384-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Cons BRONITIN MIST epinephrine bitartrate AEROSOL, METERED;INHALATION 016126-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Deproco LIGNOSPAN STANDARD epinephrine bitartrate; lidocaine hydrochloride INJECTABLE;INJECTION 088390-001 Jan 22, 1985 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dentsply Pharm CITANEST FORTE DENTAL epinephrine bitartrate; prilocaine hydrochloride INJECTABLE;INJECTION 021383-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Astrazeneca DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 017751-006 Approved Prior to Jan 1, 1982 DISCN Yes 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

Epinephrine bitartrate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epinephrine Bitartrate

Introduction to Epinephrine Bitartrate

Epinephrine bitartrate, commonly known as epinephrine, is a crucial medication used to treat severe allergic reactions, anaphylaxis, cardiac arrest, and various respiratory disorders. The market for epinephrine has been experiencing significant growth due to several key factors.

Market Size and Growth

The global epinephrine market has demonstrated robust growth in recent years. As of 2023, the market size was valued at approximately $2.44 billion and is projected to reach $2.69 billion in 2024, growing at a compound annual growth rate (CAGR) of 10.4%[1].

By 2028, the market is expected to expand to $3.82 billion with a CAGR of 9.2%[1]. Long-term projections indicate that the market will continue to grow, reaching around $6.23 billion by 2033, with a CAGR of 8.3% from 2024 to 2033[3].

Drivers of Market Growth

Several factors are driving the growth of the epinephrine market:

Rising Allergy Rates

The increasing incidence of anaphylaxis, particularly among children, is a significant driver. Approximately 5% of the U.S. population has experienced anaphylaxis, contributing to the demand for epinephrine auto-injectors[3].

Expanded Access Initiatives

Initiatives to expand access to epinephrine, including awareness campaigns and regulatory support, are enhancing market growth. Greater healthcare spending is also ensuring wider availability of epinephrine in hospitals, clinics, and emergency medical services[1].

Technological Advancements

The integration of smart devices and the development of customized epinephrine delivery systems are trends that will continue to drive market growth. These advancements improve the efficacy and accessibility of epinephrine treatments[1].

Global Expansion

The epinephrine market is expected to see significant growth in emerging markets, particularly in the Asia-Pacific region. Countries like China, India, and Japan are driving this growth due to improved healthcare infrastructure and favorable reimbursement policies[3].

Market Segmentation

The epinephrine market is segmented by type, application, and distribution channel.

By Type

  • Prefilled Syringe: Used for various medical conditions.
  • Auto-injector: Dominates the market due to its ease of use in emergency situations.
  • Ampoules and Vials: Used in hospital settings and for other medical procedures[1].

By Application

  • Anaphylaxis: The largest segment due to the growing number of anaphylaxis cases globally.
  • Cardiac Arrest: Epinephrine is crucial in treating cardiac arrest.
  • Respiratory Disorders: Growing awareness and diagnosis rates are driving this segment.
  • Other Applications: Includes superficial bleeding and other medical conditions[1][4].

By Distribution Channel

  • Retail & Online Pharmacies: Dominates the market due to easy accessibility and the increasing number of retail and online pharmacy stores.
  • Hospital Pharmacies: Expected to grow significantly due to increasing emergency hospital visits for severe allergic reactions and other conditions[4].

Regional Analysis

North America

North America, particularly the U.S., holds a significant share of the global epinephrine market. The U.S. market is projected to grow from $737.5 million in 2023 to $1,526.40 million by 2033, driven by increasing prevalence of cardiac arrest and allergic reactions[3].

Asia-Pacific

This region is expected to be the fastest-growing market due to technological advancements, better healthcare infrastructure, and favorable reimbursement policies. China, India, and Japan are leading the growth in this region[3].

Macro Economic Scenario

Impact of High Inflation

High inflation can affect the pricing and availability of epinephrine, potentially impacting market growth. However, the essential nature of epinephrine ensures continued demand despite economic fluctuations[1].

Ukraine-Russia War Impact

Global conflicts can disrupt supply chains and affect the availability of medications. However, the epinephrine market has shown resilience due to diversified manufacturing and distribution networks[1].

COVID-19 Impact

The COVID-19 pandemic highlighted the importance of emergency medical supplies, including epinephrine. This has led to increased investment in healthcare infrastructure, supporting the growth of the epinephrine market[1].

Financial Trajectory

The financial trajectory of the epinephrine market is positive, driven by increasing demand and technological advancements.

Cost-Effectiveness

Value-based pricing models suggest that the cost of epinephrine auto-injectors can be rationalized to make them more affordable. For instance, a value-based price ceiling for a personal auto-injector could be as low as $24, depending on the fatality risk protection it offers[2].

Revenue Growth

The market is expected to see significant revenue growth, with projections indicating a rise from $2.83 billion in 2023 to $6.23 billion by 2033. This growth is fueled by the increasing prevalence of allergies, improvements in production, and the rise in chronic diseases[3].

Challenges and Restraints

Despite the growth, the epinephrine market faces some challenges:

High Costs

The high cost of self-injectable epinephrine auto-injectors can be a barrier to access, particularly in low-income communities. Value-based pricing and generic alternatives are being explored to address this issue[2].

Regulatory Framework

Regulatory emphasis on product safety is crucial but can also pose challenges in terms of compliance and approval processes. However, this also drives innovation and ensures the quality of epinephrine products[1].

Key Takeaways

  • The global epinephrine market is growing rapidly due to increasing allergy rates and technological advancements.
  • The market is segmented by type, application, and distribution channel, with auto-injectors and anaphylaxis treatment being dominant segments.
  • North America and the Asia-Pacific region are key markets, with the latter expected to grow the fastest.
  • Value-based pricing and generic alternatives are being explored to make epinephrine more affordable.
  • The market is expected to reach $6.23 billion by 2033, driven by increasing healthcare expenditure and favorable reimbursement policies.

Frequently Asked Questions (FAQs)

1. What is the current market size of the global epinephrine market?

The global epinephrine market size was valued at approximately $2.44 billion in 2023[1].

2. What are the main drivers of the epinephrine market growth?

The main drivers include rising allergy rates, expanded access initiatives, technological advancements, and increasing healthcare expenditure[1][3].

3. Which region is expected to grow the fastest in the epinephrine market?

The Asia-Pacific region is expected to be the fastest-growing market due to technological advancements and favorable reimbursement policies[3].

4. What are the different types of epinephrine products available?

The market includes prefilled syringes, auto-injectors, and ampoules and vials[1].

5. How does value-based pricing impact the epinephrine market?

Value-based pricing can make epinephrine auto-injectors more affordable by setting a rational cost based on their life-saving benefits, potentially as low as $24 per device[2].

Cited Sources:

  1. The Business Research Company. Epinephrine Market Report 2024.
  2. PubMed. Association of Fatality Risk With Value-Based Drug Pricing of Epinephrine Autoinjectors.
  3. Precedence Research. Epinephrine Market Size To Attain USD 6.23 Bn By 2033.
  4. Fortune Business Insights. Epinephrine Market Size, Share, Growth & Forecast [2032].

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