You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Epinephrine; etidocaine hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Epinephrine; etidocaine hydrochloride is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. Additional information is available in the individual branded drug profile pages.

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

US Patents and Regulatory Information for epinephrine; etidocaine hydrochloride

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; etidocaine hydrochloride INJECTABLE;INJECTION 017751-004 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

Expired US Patents for epinephrine; etidocaine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca DURANEST epinephrine; etidocaine hydrochloride INJECTABLE;INJECTION 017751-004 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Astrazeneca DURANEST epinephrine; etidocaine hydrochloride INJECTABLE;INJECTION 017751-004 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Epinephrine; etidocaine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epinephrine and Etidocaine Hydrochloride

Introduction

Epinephrine and etidocaine hydrochloride are crucial components in the field of anesthesia and emergency medicine. Understanding their market dynamics and financial trajectories is essential for pharmaceutical companies, healthcare providers, and investors.

Market Overview of Epinephrine

Clinical Uses of Epinephrine

Epinephrine, also known as adrenaline, is widely used for various medical conditions, including anaphylaxis, hypotension, shock, preoperative mydriasis, and localized anesthesia[4].

Demand and Supply

The demand for epinephrine is consistent due to its life-saving applications. However, supply shortages have been a significant issue, with epinephrine products currently listed on the FDA drug shortage list. This shortage has made it necessary to compound products from bulk substances to meet demand[4].

Market Trends

The market for epinephrine is driven by its critical role in emergency medicine and anesthesia. The use of epinephrine in autoinjectors for anaphylaxis has seen significant growth, with multiple companies and generic manufacturers producing these products[5].

Financial Impact of Shortages

Supply shortages can have a negative financial impact on both manufacturers and healthcare providers. Compounding products from bulk substances, while necessary, adds to the costs and complexity of ensuring sterility and safety[4].

Market Overview of Etidocaine Hydrochloride

Clinical Uses of Etidocaine Hydrochloride

Etidocaine hydrochloride is an amide-type local anesthetic known for its prolonged duration of action. It is commonly used in oral surgery, particularly for procedures like the removal of impacted third molars[1][2].

Comparative Efficacy

Studies have shown that etidocaine hydrochloride provides anesthesia comparable to lidocaine but with a longer duration of action. This makes it a valuable option for procedures where prolonged anesthesia is beneficial[1][2].

Market Trends

The market for etidocaine hydrochloride is influenced by its efficacy in providing long-lasting anesthesia. However, it also faces competition from other local anesthetics like lidocaine and articaine.

Financial Trajectory of Epinephrine

Revenue Streams

The revenue generated from epinephrine comes from various sources, including autoinjectors for anaphylaxis, compounded products for localized anesthesia, and formulations for other medical conditions. The consistent demand due to its life-saving applications ensures a stable revenue stream[4][5].

Cost Factors

The cost of producing epinephrine products includes the cost of raw materials, manufacturing, and ensuring sterility. Supply chain disruptions and shortages can increase these costs, affecting the financial trajectory of companies involved in its production[4].

Regulatory Impact

Regulatory approvals and guidelines play a crucial role in the financial trajectory of epinephrine products. For instance, the FDA's evaluation of bulk substances for compounding can affect the availability and cost of these products[4].

Financial Trajectory of Etidocaine Hydrochloride

Revenue Streams

The revenue for etidocaine hydrochloride is primarily generated from its use in dental and surgical procedures. Its prolonged duration of action makes it a preferred choice in certain medical settings, contributing to its revenue stream[1][2].

Cost Factors

The production costs of etidocaine hydrochloride include the cost of raw materials, manufacturing, and distribution. The addition of epinephrine to etidocaine solutions can affect these costs due to the need for careful formulation to ensure efficacy and safety[3].

Competitive Landscape

The financial trajectory of etidocaine hydrochloride is also influenced by the competitive landscape of local anesthetics. Companies must balance the costs of production with the need to remain competitive in the market[1][2].

Market Dynamics: Supply and Demand

Supply Chain

The supply chain for both epinephrine and etidocaine hydrochloride is critical. For epinephrine, supply shortages have necessitated the use of bulk substances for compounding. For etidocaine hydrochloride, the supply chain must ensure the availability of high-quality raw materials to maintain efficacy and safety[4].

Demand Drivers

The demand for both drugs is driven by their clinical uses. Epinephrine's role in emergency medicine and anesthesia ensures a consistent demand, while etidocaine hydrochloride's prolonged duration of action makes it a preferred choice in certain surgical procedures[1][4].

Regulatory Environment

FDA Approvals and Guidelines

The regulatory environment plays a significant role in the market dynamics of both drugs. FDA approvals and guidelines on the use of bulk substances for compounding, as well as the evaluation of new products, can impact the financial trajectory of companies involved in their production[4][5].

Safety and Efficacy

Regulatory bodies emphasize the safety and efficacy of these drugs. For instance, the FDA has raised concerns about the reliability and safety of certain epinephrine products, which can affect their approval and market availability[5].

Future Outlook

Innovations and Developments

The future outlook for both epinephrine and etidocaine hydrochloride is influenced by ongoing innovations and developments. Improvements in formulation, delivery systems, and safety profiles can enhance their market positions and financial trajectories.

Market Expansion

Expanding into new markets and applications can also drive growth. For example, the use of epinephrine in new medical conditions or the development of new delivery systems for etidocaine hydrochloride could increase revenue streams.

Key Takeaways

  • Consistent Demand: Epinephrine's demand is consistent due to its life-saving applications, while etidocaine hydrochloride's demand is driven by its efficacy in surgical procedures.
  • Supply Chain Challenges: Supply shortages for epinephrine and the need for careful formulation for etidocaine hydrochloride affect their market dynamics.
  • Regulatory Impact: FDA approvals and guidelines significantly influence the financial trajectory of both drugs.
  • Competitive Landscape: The market for local anesthetics is competitive, with etidocaine hydrochloride facing competition from other anesthetics like lidocaine and articaine.
  • Future Innovations: Ongoing innovations and developments in formulation and delivery systems will shape the future market and financial trajectories of these drugs.

FAQs

Q: What are the primary clinical uses of epinephrine? A: Epinephrine is primarily used for anaphylaxis, hypotension, shock, preoperative mydriasis, and localized anesthesia[4].

Q: How does etidocaine hydrochloride compare to lidocaine in terms of duration of action? A: Etidocaine hydrochloride has a longer duration of action compared to lidocaine, making it 2.16 times longer acting in terms of recovery from lower lip numbness and 1.75 times longer acting in terms of the onset of postoperative pain[1].

Q: What are the financial implications of supply shortages for epinephrine? A: Supply shortages for epinephrine can increase costs due to the need for compounding from bulk substances and ensuring sterility and safety[4].

Q: How does the addition of epinephrine affect the absorption of etidocaine hydrochloride? A: The addition of epinephrine reduces the fraction of the dose being absorbed during the first phase, leading to lower plasma concentrations and a longer absorption half-life[3].

Q: What regulatory challenges do epinephrine products face? A: Epinephrine products face regulatory challenges such as ensuring sterility, safety, and efficacy, with the FDA closely evaluating these aspects before approval[4][5].

Sources

  1. The effectiveness of 1.5% etidocaine HCl with epinephrine 1:200,000... - PubMed
  2. Evaluation of etidocaine hydrochloride for local anesthesia and... - PubMed
  3. The effects of adding adrenaline to etidocaine and lignocaine in... - PubMed
  4. Epinephrine hydrochloride - The UMB Digital Archive
  5. 207534Orig1s0000MedR.pdf - FDA[4][5]

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.