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Last Updated: December 22, 2024

Epinephrine bitartrate; lidocaine hydrochloride - Generic Drug Details


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

Epinephrine bitartrate; lidocaine hydrochloride is the generic ingredient in two branded drugs marketed by Deproco and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for epinephrine bitartrate; lidocaine hydrochloride
Recent Clinical Trials for epinephrine bitartrate; lidocaine hydrochloride

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

SponsorPhase
Sunnybrook Health Sciences CentreN/A
Cosmozone Dental ClinicN/A

See all epinephrine bitartrate; lidocaine hydrochloride clinical trials

Pharmacology for epinephrine bitartrate; lidocaine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for epinephrine bitartrate; lidocaine hydrochloride
A01AD Other agents for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
B02BC Local hemostatics
B02B VITAMIN K AND OTHER HEMOSTATICS
B02 ANTIHEMORRHAGICS
B Blood and blood forming organs
C01BB Antiarrhythmics, class Ib
C01B ANTIARRHYTHMICS, CLASS I AND III
C01 CARDIAC THERAPY
C Cardiovascular system
C01CA Adrenergic and dopaminergic agents
C01C CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01 CARDIAC THERAPY
C Cardiovascular system
C05AD Local anesthetics
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D04AB Anesthetics for topical use
D04A ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04 ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D Dermatologicals
N01BB Amides
N01B ANESTHETICS, LOCAL
N01 ANESTHETICS
N Nervous system
R01AA Sympathomimetics, plain
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R02AD Anesthetics, local
R02A THROAT PREPARATIONS
R02 THROAT PREPARATIONS
R Respiratory system
R03AA Alpha- and beta-adrenoreceptor agonists
R03A ADRENERGICS, INHALANTS
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R Respiratory system
S01EA Sympathomimetics in glaucoma therapy
S01E ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01HA Local anesthetics
S01H LOCAL ANESTHETICS
S01 OPHTHALMOLOGICALS
S Sensory organs
S02DA Analgesics and anesthetics
S02D OTHER OTOLOGICALS
S02 OTOLOGICALS
S Sensory organs

US Patents and Regulatory Information for epinephrine bitartrate; lidocaine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Deproco LIGNOSPAN FORTE epinephrine bitartrate; lidocaine hydrochloride INJECTABLE;INJECTION 088389-001 Jan 22, 1985 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Deproco LIGNOSPAN STANDARD epinephrine bitartrate; lidocaine hydrochloride INJECTABLE;INJECTION 088390-001 Jan 22, 1985 RX Yes Yes ⤷  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; lidocaine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Epinephrine Bitartrate and Lidocaine Hydrochloride

Introduction

Epinephrine bitartrate and lidocaine hydrochloride are two widely used pharmaceuticals, particularly in the fields of anesthesia, pain management, and emergency medicine. This article delves into the market dynamics and financial trajectory of these drugs, highlighting their current status, future projections, and key factors influencing their market performance.

Market Overview

Lidocaine Hydrochloride Market

The global lidocaine hydrochloride market is poised for significant growth. It is expected to expand at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2030[3].

Epinephrine Bitartrate Market

Epinephrine, often used in combination with local anesthetics like lidocaine, also sees substantial demand. Its market is driven by its versatile applications, including anaphylaxis treatment, vasoconstriction in local anesthesia, and various other medical conditions[4].

Key Drivers of Market Growth

Increasing Surgical Procedures

The rise in the number of surgical procedures, including dental, cosmetic, and plastic surgeries, is a major driver for the lidocaine hydrochloride market. For instance, the American Society of Plastic Surgeons reported a 19% increase in cosmetic surgeries since 2019[3].

Growing Need for Pain Management

The increasing incidence of acute and chronic pain-related diseases further boosts the demand for lidocaine hydrochloride. Creams and other formulations of lidocaine are preferred for their minimal side effects and comfort in pain management[3].

COVID-19 Impact

The COVID-19 pandemic had a notable impact on the lidocaine hydrochloride market. Nebulized lidocaine was explored as an adjuvant treatment for severe lung symptoms in COVID-19 patients, contributing to market growth during the pandemic[3].

Market Segmentation

Dosage Forms

The lidocaine hydrochloride market is segmented into various dosage forms, including creams, patches, injectables, and others. The cream segment held the largest market share in 2023, driven by patient preference for non-invasive pain management solutions[3].

Indications

Lidocaine hydrochloride is used in several indications, with dental procedures holding the largest market share. Its widespread use in numbing affected areas during dental procedures is a significant factor driving this segment[3].

Distribution Channels

Retail pharmacies dominate the distribution channels for lidocaine hydrochloride, driven by the increasing availability of over-the-counter (OTC) prescriptions and high generic penetration[3].

Regional Market Analysis

North America

North America is the leading region for the lidocaine hydrochloride market, driven by an increasing geriatric population and a high number of surgical procedures. Technological advancements in surgical procedures and the growing use of lidocaine for postoperative pain management also contribute to regional growth[3].

Financial Trajectory

Revenue Projections

The global lidocaine hydrochloride market is expected to see substantial revenue growth, driven by the increasing demand for pain management solutions and the rising number of surgical procedures. By 2030, the market is projected to reach significant heights, with a CAGR of 6.5% from 2024 to 2030[3].

Key Players and Strategic Initiatives

Major players in the market, such as Pfizer Inc., Merck KGaA, and Sintetica S.A., are undertaking various strategic initiatives including new product launches, partnerships, and mergers and acquisitions to gain market share. For example, Sintetica S.A. launched Lidocaine Hydrochloride Injection, USP in various concentrations in 2023[3].

Pharmacological and Clinical Aspects

Mechanism of Action

Lidocaine hydrochloride works by blocking sodium channels, thereby preventing the initiation and transmission of nerve impulses. When combined with epinephrine, it enhances the duration of anesthesia and reduces systemic side effects due to vasoconstriction caused by epinephrine[2][5].

Metabolism and Elimination

Lidocaine hydrochloride is rapidly metabolized by the liver and excreted by the kidneys. Its elimination half-life is typically 1.5 to 2 hours but can be prolonged in patients with liver dysfunction[2][5].

Safety and Side Effects

Both lidocaine and epinephrine can cause side effects, including allergic reactions and systemic toxicity. Lidocaine hydrochloride contains sodium metabisulfite, which can cause allergic-type reactions in susceptible individuals, particularly those with asthma[2].

Regulatory Environment

Approval and Compliance

Products containing lidocaine hydrochloride and epinephrine must comply with stringent regulatory requirements. For instance, the stability and sterility of these products are rigorously tested, and manufacturers must provide data on their compliance with pharmacopeial standards[1][5].

Compounding Regulations

Epinephrine hydrochloride has been nominated for inclusion on the 503B Bulks List by the FDA, which involves a thorough evaluation of its use in clinical practice and compounding by outsourcing facilities[4].

Market Challenges

Competition

The market for lidocaine hydrochloride and epinephrine is highly competitive, with multiple generic and branded products available. This competition can impact pricing and market share for individual manufacturers[3].

Regulatory Hurdles

Stringent regulatory requirements and the need for continuous compliance can pose challenges for manufacturers. Any changes in regulatory standards can affect the production and distribution of these drugs[1][4].

Future Outlook

Technological Advancements

Advancements in drug delivery systems and formulations are expected to enhance the efficacy and safety of lidocaine hydrochloride and epinephrine products. This could include new topical formulations or more targeted delivery methods[3].

Expanding Applications

The potential use of lidocaine hydrochloride in new indications, such as its anti-inflammatory effects in COVID-19 treatment, could further expand its market[3].

Key Takeaways

  • The lidocaine hydrochloride market is expected to grow at a CAGR of 6.5% from 2024 to 2030.
  • Increasing surgical procedures and the growing need for pain management are key drivers of market growth.
  • Epinephrine bitartrate, when combined with lidocaine, enhances the duration of anesthesia and reduces systemic side effects.
  • The market is highly competitive, with major players undertaking strategic initiatives to gain market share.
  • Regulatory compliance and technological advancements are crucial for future market growth.

FAQs

Q: What are the primary indications for lidocaine hydrochloride?

A: Lidocaine hydrochloride is primarily used for local or regional anesthesia, dental procedures, heart arrhythmia, and pain management[2][3].

Q: How does epinephrine bitartrate enhance the effect of lidocaine hydrochloride?

A: Epinephrine causes vasoconstriction, which delays the absorption of lidocaine, increasing its concentration at the site of action and reducing systemic side effects[1][2].

Q: What is the impact of the COVID-19 pandemic on the lidocaine hydrochloride market?

A: The pandemic led to increased use of lidocaine hydrochloride in treating severe lung symptoms in COVID-19 patients, contributing to market growth[3].

Q: Which region dominates the lidocaine hydrochloride market?

A: North America is the leading region for the lidocaine hydrochloride market, driven by an increasing geriatric population and a high number of surgical procedures[3].

Q: What are the common side effects of lidocaine hydrochloride and epinephrine?

A: Common side effects include allergic reactions, systemic toxicity, and in the case of lidocaine, potential allergic reactions to sodium metabisulfite[2].

Sources

  1. Public Assessment Report - Geneesmiddeleninformatiebank
  2. Lidocaine Hydrochloride and Epinephrine Injection, USP - Pfizer
  3. Lidocaine Hydrochloride Market Size & Share Report, 2030 - Grand View Research
  4. Epinephrine hydrochloride - The UMB Digital Archive
  5. Xylocaine-MPF (Epinephrine and Lidocaine Hydrochloride) - FDA

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