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Last Updated: December 22, 2024

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE - Generic Drug Details


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

Epinephrine; lidocaine hydrochloride is the generic ingredient in nine branded drugs marketed by Carlisle, B Braun Medical Inc, Belmora Llc, Eastman Kodak, Hospira, West-ward Pharms Int, Abbott, Bel Mar, Dell Labs, Intl Medication, Watson Labs, Pharmaton, Septodont, Dentsply Pharm, Astrazeneca, Fresenius Kabi Usa, Vyteris, Iomed, and Empi, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

Eleven suppliers are listed for this compound.

Summary for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Recent Clinical Trials for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

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

SponsorPhase
Montefiore Medical CenterN/A
Jessyka LighthallPhase 3
Assiut UniversityN/A

See all EPINEPHRINE; LIDOCAINE HYDROCHLORIDE clinical trials

Pharmacology for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for EPINEPHRINE; 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; LIDOCAINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 078772-001 May 12, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 089644-001 Jun 21, 1988 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Belmora Llc LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 080504-004 Oct 19, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bel Mar LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 080820-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 089651-001 Jun 21, 1988 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa XYLOCAINE W/ EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 006488-004 Approved Prior to Jan 1, 1982 AP 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

Expired US Patents for EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004 ⤷  Subscribe ⤷  Subscribe
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004 ⤷  Subscribe ⤷  Subscribe
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004 ⤷  Subscribe ⤷  Subscribe
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004 ⤷  Subscribe ⤷  Subscribe
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004 ⤷  Subscribe ⤷  Subscribe
Vyteris LIDOSITE TOPICAL SYSTEM KIT epinephrine; lidocaine hydrochloride PATCH;IONTOPHORESIS, TOPICAL 021504-001 May 6, 2004 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Lidocaine Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

The lidocaine hydrochloride market is poised for significant growth, driven by various factors including the increasing demand for pain management solutions, advancements in medical procedures, and the expanding elderly population.

Market Size and Growth Projections

  • The global lidocaine market was valued at USD 682.22 million in 2021 and is expected to reach USD 1,137.31 million by 2030, registering a CAGR of 5.8% during the forecast period[1].
  • Another projection indicates that the lidocaine hydrochloride market size was valued at USD 512.70 million in 2023 and is anticipated to grow to USD 838.60 million by 2032, with a CAGR of 5.7% from 2024 to 2032[4].

Key Drivers of Market Growth

Increasing Demand for Pain Management

The rising prevalence of chronic pain conditions and the growing need for effective pain management solutions, particularly among the aging population, are significant drivers of the lidocaine hydrochloride market. The drug's versatility in providing diverse formulations such as creams and injections caters to a broad spectrum of medical requirements[4].

Advancements in Medical Procedures

The market is also driven by the increasing number of minimally invasive surgical procedures, dental surgeries, and cosmetic procedures. Innovations in surgical procedures and the use of lidocaine hydrochloride in post-operative pain management further contribute to market growth[1][4].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the market due to the potential anesthetic and anti-inflammatory properties of lidocaine. For instance, nebulized lidocaine was proposed as a beneficial treatment for reducing cytokines and improving outcomes in COVID-19 patients, which boosted market growth during the pandemic period[3].

Distribution Channels and Administration Routes

Distribution Channels

The online distribution channel segment is expected to register the fastest CAGR during the forecast period due to greater customer accessibility and lower operating costs. Patients are increasingly turning to online channels for virtual treatment, drugs, and wellness options, a trend accelerated by the COVID-19 pandemic[1].

Administration Routes

The lidocaine market is segmented into topical and injectable forms. The injectable segment is expected to register the fastest CAGR, primarily due to its use in treating irregular heart rhythms and minimizing discomfort during labor. The high prevalence of cardiovascular disorders also drives the demand for lidocaine injections[1].

Regional Market Dynamics

Asia Pacific

The Asia Pacific region is expected to register the fastest CAGR of 6.7% during the forecast period. This growth is attributed to the large population suffering from chronic diseases, increasing disposable income, and growing investments in the healthcare sector in countries like India and China[1].

North America

North America dominated the global lidocaine hydrochloride market in 2023 and is expected to maintain its dominance. The region's growth is driven by the rising number of aging people, the increasing quantity of surgical procedures, and advancements in technological innovations in various surgical procedures[4].

Competitive Landscape

The lidocaine hydrochloride market is moderately fragmented with several key players operating globally and regionally. Major companies such as Pfizer, Inc., AstraZeneca Plc, Glenmark Pharmaceuticals, Teva Pharmaceutical Industries Ltd, and Viatris Inc. are engaged in product development and strategic alliances to expand their product portfolios and gain a competitive edge[1].

Challenges and Restraints

Regulatory Scrutiny

Regulatory scrutiny poses a significant challenge to the market, requiring stringent adherence to safety standards and thorough approvals. The potential side effects associated with lidocaine hydrochloride also contribute to cautious adoption[4].

Competition from Alternative Solutions

The market faces competition from alternative pain management solutions, which can impede growth. Continuous research is necessary to address safety concerns and maintain market momentum[4].

Clinical and Medical Significance

Hemodynamic Effects

Studies have shown that the use of lidocaine with different concentrations of epinephrine can have varying hemodynamic effects. For instance, lidocaine with 1:200,000 epinephrine does not lead to significant hemodynamic fluctuations or increased intraoperative bleeding compared to lidocaine with 1:100,000 epinephrine, making it a safer option for certain surgical procedures[2].

Key Takeaways

  • The lidocaine hydrochloride market is expected to grow significantly, driven by increasing demand for pain management, advancements in medical procedures, and the expanding elderly population.
  • Online distribution channels and injectable administration routes are expected to see rapid growth.
  • The Asia Pacific and North America regions are key drivers of market growth.
  • Regulatory scrutiny and competition from alternative solutions are significant challenges.
  • Continuous research and strategic alliances are crucial for market players to maintain a competitive edge.

FAQs

What is the projected market size of the lidocaine hydrochloride market by 2030?

The lidocaine market is expected to reach USD 1,137.31 million by 2030[1].

What are the key drivers of the lidocaine hydrochloride market?

The key drivers include the increasing demand for pain management solutions, advancements in medical procedures, and the expanding elderly population[1][4].

How does the COVID-19 pandemic impact the lidocaine hydrochloride market?

The pandemic boosted market growth due to the potential anesthetic and anti-inflammatory properties of lidocaine, particularly in treating COVID-19 patients[3].

Which region is expected to register the fastest CAGR in the lidocaine hydrochloride market?

The Asia Pacific region is expected to register the fastest CAGR of 6.7% during the forecast period[1].

What are the major challenges facing the lidocaine hydrochloride market?

Regulatory scrutiny, potential side effects, and competition from alternative pain management solutions are significant challenges[4].

Sources

  1. Reports and Data: Lidocaine Market Size, Share, Growth, Trends & Forecasts To 2030
  2. JAMA Otolaryngology: The Hemostatic and Hemodynamic Effects of Epinephrine During Functional Endoscopic Sinus Surgery
  3. Mordor Intelligence: Lidocaine Hydrochloride Market - Share, Trends & Size
  4. Polaris Market Research: Lidocaine Hydrochloride Market Size, Share, Global Analysis Report
  5. GlobeNewswire: Lidocaine Market Size is projected to reach USD 3.05 Billion by 2029, growing at a CAGR of 8.45% - Straits Research

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