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Last Updated: April 23, 2025

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE Drug Patent Profile


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When do Lidocaine Hydrochloride Preservative Free patents expire, and what generic alternatives are available?

Lidocaine Hydrochloride Preservative Free is a drug marketed by Eugia Pharma, Extrovis, Fresenius Kabi Usa, Hikma, Hospira, and Intl Medication. and is included in nine NDAs.

The generic ingredient in LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Lidocaine Hydrochloride Preservative Free

A generic version of LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE was approved as lidocaine hydrochloride by XTTRIUM LABS INC on November 18th, 1982.

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Summary for LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Drug patent expirations by year for LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Recent Clinical Trials for LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

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

SponsorPhase
University of California, San FranciscoPhase 4
Sindh Institute of Urology and TransplantationPhase 4
Fayoum UniversityPhase 1

See all LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE clinical trials

Pharmacology for LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

US Patents and Regulatory Information for LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Fresenius Kabi Usa LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 017584-002 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 084625-001 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 088295-001 May 17, 1984 AP RX No Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Eugia Pharma LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 203040-001 Mar 14, 2013 AP RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Eugia Pharma LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 203082-002 Mar 14, 2013 AP RX No 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 5 of 5 entries

Lidocaine Hydrochloride Preservative Free: Market Dynamics and Financial Trajectory

Market Overview

The lidocaine hydrochloride market, particularly the preservative-free segment, is poised for significant growth driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of lidocaine hydrochloride preservative free.

Market Size and Growth

The lidocaine hydrochloride market is expected to record a Compound Annual Growth Rate (CAGR) of 4.1% during the forecast period from 2024 to 2029[1][3][4].

  • In 2023, the market size was valued at USD 512.70 million and is anticipated to grow to USD 838.60 million by 2032[4].

Key Drivers

Increasing Demand for Pain Management

The rising prevalence of chronic pain conditions and the growing need for effective pain management solutions are significant drivers of the market. Lidocaine hydrochloride, especially in preservative-free formulations, is widely used in various medical procedures to manage pain[4].

Expanding Elderly Population

The global population, particularly the aging demographic, plays a crucial role in propelling the lidocaine hydrochloride market. The elderly population requires more frequent medical and surgical procedures, which increases the demand for lidocaine hydrochloride[4].

Technological Advancements

Progress in drug delivery technologies has led to the development of innovative formulations such as creams and injections, enhancing the effectiveness and flexibility of lidocaine hydrochloride. These advancements are expected to continue driving market growth[4].

Post-Pandemic Recovery

The COVID-19 pandemic had a notable impact on the market due to the potential anesthetic and anti-inflammatory properties of lidocaine in treating COVID-19 patients. The relaxation of strict regulations on surgical procedures in the post-pandemic period and the resumption of services are expected to boost the demand for lidocaine hydrochloride[1][3].

Regional Analysis

North America

North America accounts for the largest market share in the lidocaine hydrochloride market. This dominance is attributed to the rising number of aging people and the increasing quantity of surgical procedures in the region. Technological advancements in surgical procedures and the growing usage of lidocaine hydrochloride for postoperative pain management also contribute to the region's leading position[4].

Asia Pacific

The Asia Pacific region is estimated to be the fastest-growing market over the forecast period. This growth is driven by the increasing prevalence of dental and cosmetic procedures, along with a growing awareness and accessibility of lidocaine hydrochloride products in the region[1].

Distribution Channels

Retail pharmacies have emerged as the dominant players in the distribution channels segment. The increasing prevalence of dental and cosmetic procedures, coupled with a surge in demand for efficient pain management solutions, drives the prominence of retail pharmacies in distributing lidocaine products[4].

Market Challenges

Regulatory Scrutiny

Regulatory scrutiny poses a significant challenge to the market. Stringent adherence to safety standards and thorough approvals are required, which can impede market growth. The potential side effects associated with lidocaine hydrochloride also contribute to cautious adoption[4].

Competition from Alternative Solutions

The market faces intense competition from alternative pain management solutions. Continuous research is needed to address safety concerns and differentiate lidocaine hydrochloride from other options[4].

Supply Chain Disruptions

Supply chain disruptions, including backorders and allocation issues, affect the availability of lidocaine hydrochloride products. For instance, Pfizer and other manufacturers have several products on backorder with estimated release dates extending into 2026[5].

Key Players

Major companies operating in the lidocaine hydrochloride market include Pfizer Inc., Merck KGaA, Mahendra Chemicals, Nortec Quimica, and Cirondrugs. These companies are investing in research and development to introduce new and safer products, which is expected to enhance market growth[1].

Therapeutic Applications

Lidocaine hydrochloride is extensively used in various therapeutic applications, including:

Surgical Procedures

Lidocaine hydrochloride is a crucial anesthetic in surgical procedures, providing effective pain management during and after surgery[3].

Dental Procedures

The drug is widely used in dental procedures due to its quick onset of action and effectiveness in managing dental pain[3].

Cosmetic Procedures

Lidocaine hydrochloride is also used in cosmetic procedures to minimize pain and discomfort[3].

Pain-Related Disorders

It has potential benefits in treating pain-related disorders such as epilepsy and heart arrhythmia[3].

Financial Projections

  • The market is anticipated to grow from USD 538.44 million in 2024 to USD 838.60 million by 2032, exhibiting a CAGR of 5.7% during the forecast period[4].

Impact of COVID-19

COVID-19 had a significant impact on the market due to the potential benefits of lidocaine in treating severe respiratory symptoms in COVID-19 patients. For instance, nebulized lidocaine was proposed as a beneficial adjunctive treatment for reducing cytokines and protecting patients' lungs[1][3].

Key Takeaways

  • The lidocaine hydrochloride market is expected to grow at a CAGR of 4.1% from 2024 to 2029.
  • North America holds the largest market share, while the Asia Pacific region is the fastest-growing market.
  • The market is driven by the increasing demand for pain management, technological advancements, and the expanding elderly population.
  • Regulatory scrutiny, competition from alternative solutions, and supply chain disruptions are key challenges.
  • Major players include Pfizer Inc., Merck KGaA, and others, who are focusing on introducing new and safer products.

FAQs

What is the current market size of the lidocaine hydrochloride market?

The lidocaine hydrochloride market was valued at USD 512.70 million in 2023[4].

Which region dominates the global lidocaine hydrochloride market?

North America accounts for the largest market share in the lidocaine hydrochloride market[4].

What are the key drivers of the lidocaine hydrochloride market?

The key drivers include the increasing demand for pain management, the expanding elderly population, and technological advancements in drug delivery[4].

What are the major challenges facing the lidocaine hydrochloride market?

Regulatory scrutiny, competition from alternative pain management solutions, and supply chain disruptions are significant challenges[4].

Who are the major players in the lidocaine hydrochloride market?

Major players include Pfizer Inc., Merck KGaA, Mahendra Chemicals, Nortec Quimica, and Cirondrugs[1].

References

  1. Mordor Intelligence: Lidocaine Hydrochloride Market - Share, Trends & Size.
  2. Henry Schein: Lidocaine HCl Injection 1% Preservative Free SDV 30mL Each.
  3. Mordor Intelligence: Lidocaine Hydrochloride Market Size - Mordor Intelligence.
  4. Polaris Market Research: Lidocaine Hydrochloride Market Size, Share, Global Analysis Report.
  5. ASHP: Drug Shortage Detail: Lidocaine Injection.

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