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Last Updated: March 16, 2025

Epinephrine bitartrate; etidocaine hydrochloride - Generic Drug Details


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

Epinephrine bitartrate; etidocaine hydrochloride is the generic ingredient in one branded drug marketed by Astrazeneca and Dentsply Pharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for epinephrine bitartrate; etidocaine hydrochloride
US Patents:0
Tradenames:1
Applicants:2
NDAs:2
DailyMed Link:epinephrine bitartrate; etidocaine hydrochloride at DailyMed

US Patents and Regulatory Information for epinephrine bitartrate; etidocaine hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Astrazeneca DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 017751-006 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Astrazeneca DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 017751-007 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Dentsply Pharm DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 021384-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Expired US Patents for epinephrine bitartrate; etidocaine hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Astrazeneca DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 017751-006 Approved Prior to Jan 1, 1982 ⤷  Try for Free ⤷  Try for Free
Astrazeneca DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 017751-007 Approved Prior to Jan 1, 1982 ⤷  Try for Free ⤷  Try for Free
Astrazeneca DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 017751-006 Approved Prior to Jan 1, 1982 ⤷  Try for Free ⤷  Try for Free
Astrazeneca DURANEST epinephrine bitartrate; etidocaine hydrochloride INJECTABLE;INJECTION 017751-007 Approved Prior to Jan 1, 1982 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Epinephrine Bitartrate and Etidocaine Hydrochloride

Introduction to Epinephrine Bitartrate and Etidocaine Hydrochloride

Epinephrine Bitartrate is the bitartrate salt form of epinephrine, a direct-acting sympathomimetic amine with bronchodilator and vasoconstricting activity. It is widely used in medical emergencies, particularly for treating anaphylaxis and severe allergic reactions[2].

Etidocaine Hydrochloride, marketed under the trade name Duranest, is an amide-type local anesthetic used in surgical procedures and labor. It is known for its long duration of activity but has the disadvantage of increased bleeding during surgery[5].

Market Overview of Epinephrine Bitartrate

Market Size and Growth

The epinephrine market, which includes epinephrine bitartrate, has seen significant growth in recent years. In 2023, the global epinephrine market size was valued at $2.44 billion and is expected to grow to $2.69 billion in 2024 at a compound annual growth rate (CAGR) of 10.4%. By 2028, the market is projected to reach $3.82 billion with a CAGR of 9.2%[4].

Key Drivers

  • Rising Allergy Rates: The increasing incidence of anaphylaxis and other severe allergies is a major driver for the epinephrine market.
  • Regulatory Framework: Strong regulatory support and emphasis on product safety are contributing to market growth.
  • Patient Education and Awareness: Improved patient education and awareness campaigns are increasing the demand for epinephrine products.
  • Healthcare Expenditure: Rising healthcare expenditure is enabling wider availability of epinephrine in hospitals and emergency services[4].

Market Segmentation

The epinephrine bitartrate market can be segmented based on product types, major applications, and regions. North America was the largest region in the epinephrine market in 2023, followed by other regions such as Asia-Pacific, Western Europe, and Eastern Europe[4].

Market Dynamics of Etidocaine Hydrochloride

Clinical Use and Demand

Etidocaine hydrochloride is primarily used as a local anesthetic in surgical procedures and labor. Its long duration of activity makes it a preferred choice in certain medical scenarios, despite its potential for increased bleeding during surgery[5].

Market Size and Growth

While specific financial data for etidocaine hydrochloride is not as readily available as for epinephrine, the demand for local anesthetics is generally driven by the volume of surgical procedures and the need for effective pain management. The market for local anesthetics, including etidocaine, is expected to grow steadily due to increasing surgical volumes and advancements in medical procedures.

Key Drivers

  • Surgical Volume: The increasing number of surgical procedures globally drives the demand for local anesthetics like etidocaine.
  • Advancements in Medical Procedures: New surgical techniques and the need for more effective pain management solutions contribute to the growth of the local anesthetic market.
  • Competition and Innovation: The local anesthetic market is competitive, with various products available. Innovation in delivery systems and formulations can influence market dynamics[5].

Financial Trajectory for Epinephrine Bitartrate

Revenue Projections

The epinephrine market, including epinephrine bitartrate, is expected to see strong growth. From $2.44 billion in 2023, the market will grow to $2.69 billion in 2024 and reach $3.82 billion by 2028. This growth is driven by rising allergy rates, expanded access initiatives, and increased healthcare expenditure[4].

Regional Performance

North America is currently the largest market for epinephrine, followed by other regions. The regional performance is influenced by factors such as healthcare policies, regulatory frameworks, and the prevalence of allergies.

Product Innovation

Major companies in the epinephrine market are focusing on product innovation, such as advanced auto-injectors and convenient formulations, to improve market position and meet growing demand. For example, Baxter International Inc. launched a new formulation of norepinephrine bitartrate in 2021, which is a related product in the sympathomimetic amine category[4].

Financial Trajectory for Etidocaine Hydrochloride

Market Position

While etidocaine hydrochloride is a significant player in the local anesthetic market, its financial trajectory is more stable and less explosive compared to the epinephrine market. The demand for etidocaine is consistent due to its established use in surgical procedures.

Revenue Streams

The revenue for etidocaine hydrochloride comes from sales in various healthcare settings, including hospitals and clinics. The market value includes the revenues generated by manufacturers from the sale of goods and related services.

Competitive Landscape

The local anesthetic market is competitive, with several products available. Etidocaine hydrochloride competes with other local anesthetics, and its market share is influenced by factors such as efficacy, safety profile, and cost.

Key Trends and Innovations

Integration of Smart Devices

In the epinephrine market, there is a trend towards integrating smart devices with epinephrine delivery systems to enhance patient safety and compliance. This includes smart auto-injectors that can alert emergency services and track usage[4].

Enhanced Education and Awareness

Both markets benefit from enhanced education and awareness programs. For epinephrine, this includes educating patients and caregivers on the proper use of auto-injectors, while for etidocaine, it involves educating healthcare professionals on the optimal use of local anesthetics.

Global Expansion and Regulatory Emphasis

The global expansion of epinephrine access and the regulatory emphasis on product safety are crucial trends. For etidocaine, regulatory approvals and compliance with safety standards are essential for maintaining market presence.

Challenges and Opportunities

Regulatory Challenges

Both markets face regulatory challenges. For epinephrine, ensuring compliance with safety standards and obtaining regulatory approvals for new formulations is critical. For etidocaine, maintaining regulatory compliance and addressing any safety concerns are key challenges[4].

Market Opportunities

The rising prevalence of allergies and chronic respiratory diseases presents significant opportunities for the epinephrine market. For etidocaine, the increasing volume of surgical procedures and the need for effective pain management solutions offer growth opportunities.

Conclusion

The markets for epinephrine bitartrate and etidocaine hydrochloride are driven by different factors but share common themes such as regulatory compliance, product innovation, and increasing demand due to healthcare needs.

Key Takeaways

  • Epinephrine Bitartrate Market Growth: Expected to grow from $2.44 billion in 2023 to $3.82 billion by 2028.
  • Key Drivers: Rising allergy rates, expanded access initiatives, and increased healthcare expenditure.
  • Etidocaine Hydrochloride Market: Stable demand driven by surgical volumes and the need for effective pain management.
  • Product Innovation: Advanced auto-injectors and convenient formulations are key trends in the epinephrine market.
  • Regulatory Emphasis: Compliance with safety standards is crucial for both markets.

Frequently Asked Questions (FAQs)

1. What is the primary use of epinephrine bitartrate? Epinephrine bitartrate is primarily used to treat anaphylaxis and severe allergic reactions due to its bronchodilator and vasoconstricting properties.

2. How does the addition of adrenaline affect local anesthetics like etidocaine? The addition of adrenaline to local anesthetics like etidocaine reduces the fraction of the dose being absorbed during the initial phase, leading to lower plasma concentrations and a longer duration of action[3].

3. What are the key drivers of the epinephrine market? The key drivers include rising allergy rates, expanded access initiatives, increased healthcare expenditure, and regulatory emphasis on product safety[4].

4. What is the expected growth of the epinephrine market by 2028? The epinephrine market is expected to grow to $3.82 billion by 2028 at a CAGR of 9.2%[4].

5. How does etidocaine hydrochloride compare to other local anesthetics in terms of duration of action? Etidocaine hydrochloride has a long duration of activity compared to other local anesthetics, making it a preferred choice in certain surgical procedures[5].

Cited Sources

  1. Reports and Markets: Global Epinephrine Bitartrate Market Report.
  2. PubChem: Epinephrine Bitartrate.
  3. PubMed: The effects of adding adrenaline to etidocaine and lignocaine.
  4. The Business Research Company: Epinephrine Global Market Report 2024.
  5. Wikipedia: Etidocaine.

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