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Last Updated: April 1, 2025

LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% Drug Patent Profile


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Which patents cover Lidocaine Hydrochloride 0.4% In Dextrose 5%, and when can generic versions of Lidocaine Hydrochloride 0.4% In Dextrose 5% launch?

Lidocaine Hydrochloride 0.4% In Dextrose 5% is a drug marketed by Hospira and is included in two NDAs.

The generic ingredient in LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% 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 0.4% In Dextrose 5%

A generic version of LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% was approved as lidocaine hydrochloride by WOCKHARDT BIO AG on November 18th, 1982.

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Summary for LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%
Drug patent expirations by year for LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%
Recent Clinical Trials for LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

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

SponsorPhase
Sichuan Cancer Hospital and Research InstituteN/A
Jessyka LighthallPhase 3
Sawanpracharak hospitalN/A

See all LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% clinical trials

Pharmacology for LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

US Patents and Regulatory Information for LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hospira LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER lidocaine hydrochloride INJECTABLE;INJECTION 018388-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% lidocaine hydrochloride INJECTABLE;INJECTION 083158-006 Approved Prior to Jan 1, 1982 DISCN 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 2 of 2 entries

Market Dynamics and Financial Trajectory for Lidocaine Hydrochloride 0.4% in Dextrose 5%

Introduction

Lidocaine Hydrochloride 0.4% in Dextrose 5% is a widely used pharmaceutical product, particularly as a cardiac antiarrhythmic agent and for pain management. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including manufacturers, investors, and healthcare providers.

Global Market Size and Growth

The global lidocaine hydrochloride market has been experiencing significant growth. As of 2023, the market size was estimated to be USD 0.773 billion and is projected to reach USD 1.56 billion by 2034, with a Compound Annual Growth Rate (CAGR) of 6.57% during the forecast period of 2024-2034[3].

Key Drivers of Market Growth

Several factors are driving the growth of the lidocaine hydrochloride market:

Increasing Surgical and Dental Procedures

The rising number of surgical and dental procedures globally is a major driver. Lidocaine hydrochloride is extensively used for local and regional anesthesia, making it a staple in these procedures[3].

Growing Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases, which often require pain management solutions, is another significant factor. Lidocaine hydrochloride is used in various medical specialties for pain relief[3].

Technological Advancements

Advancements in drug delivery systems and pharmaceutical formulations are expanding the scope of lidocaine hydrochloride applications. This includes the development of more convenient and non-invasive pain management solutions, such as creams and gels[3].

Consumer Awareness and Demand

Rising consumer awareness and demand for effective pain management solutions are also contributing to the market growth. The ease of application and patient-friendly nature of lidocaine hydrochloride products, especially creams, have made them popular among consumers[3].

Market Segmentation

By Dosage Form

The cream segment accounted for the highest revenue in the global lidocaine hydrochloride market in 2023 due to its ease of application and widespread use for topical anesthesia. However, the other dosage forms segment is predicted to grow at the fastest CAGR during the forecast period, driven by the demand for diverse and specialized pharmaceutical formulations[3].

By Application

Dental procedures accounted for the highest revenue-grossing segment in 2023, driven by the growing prevalence of dental conditions and an emphasis on pain management in dental practices. Other segments, including various medical specialties, are expected to grow rapidly due to the increasing adoption of lidocaine hydrochloride in diverse applications[3].

By Distribution Channel

Retail pharmacies were the highest revenue-grossing segment in 2023, thanks to the increasing accessibility of over-the-counter lidocaine hydrochloride products. However, online pharmacies are expected to grow at the fastest CAGR, driven by the trend of online shopping and expanding digital healthcare services[3].

Financial Performance and Projections

Revenue Growth

The projected growth from USD 0.773 billion in 2023 to USD 1.56 billion by 2034 indicates a robust financial trajectory. This growth is supported by increasing demand across various segments and the expansion of distribution channels[3].

Key Players and Partnerships

Major pharmaceutical companies such as AstraZeneca plc, Hikma Pharmaceuticals, and Fresenius Kabi are actively involved in the market. Partnerships, such as the one between AstraZeneca and Hikma to commercialize the Xylocaine portfolio, are further boosting market growth[3].

Production Capacity

Companies like Fresenius Kabi have doubled their injectable lidocaine production capacity in response to rising demand, indicating a strong commitment to meeting market needs and driving financial performance[3].

Challenges and Considerations

Regulatory Environment

The use of lidocaine hydrochloride is subject to regulatory approvals and guidelines. For instance, Johnson & Johnson received FDA permission for a specific use of lidocaine hydrochloride, highlighting the importance of regulatory compliance[3].

Safety and Efficacy

Lidocaine hydrochloride must be used with caution in certain patient groups, such as those with epilepsy, impaired cardiac conduction, or severe liver and renal diseases. Ensuring safety and efficacy is crucial for maintaining market trust and compliance[5].

Storage and Handling

Proper storage and handling of lidocaine hydrochloride solutions are essential to maintain their efficacy and safety. Exposure to excessive heat or freezing should be avoided, and the product should be stored at room temperature[4].

Key Takeaways

  • The global lidocaine hydrochloride market is expected to grow significantly, driven by increasing surgical and dental procedures, growing chronic disease prevalence, and technological advancements.
  • The cream segment and dental procedures are currently leading in terms of revenue, but other dosage forms and applications are expected to grow rapidly.
  • Retail pharmacies are the primary distribution channel, but online pharmacies are gaining traction.
  • Major pharmaceutical companies are investing heavily in production capacity and partnerships to meet the rising demand.
  • Regulatory compliance, safety, and proper storage and handling are critical for maintaining market growth.

FAQs

What is the projected market size of lidocaine hydrochloride by 2034?

The global lidocaine hydrochloride market is expected to reach USD 1.56 billion by 2034[3].

Which segment accounts for the highest revenue in the lidocaine hydrochloride market?

The cream segment currently accounts for the highest revenue due to its ease of application and widespread use for topical anesthesia[3].

What are the key drivers of the lidocaine hydrochloride market growth?

Key drivers include increasing surgical and dental procedures, growing prevalence of chronic diseases, technological advancements, and rising consumer awareness and demand for pain management solutions[3].

Which distribution channel is expected to grow the fastest in the lidocaine hydrochloride market?

Online pharmacies are expected to grow at the fastest CAGR due to the trend of online shopping and expanding digital healthcare services[3].

What are the safety considerations for using lidocaine hydrochloride?

Lidocaine hydrochloride should be used with caution in patients with epilepsy, impaired cardiac conduction, bradycardia, impaired hepatic or renal function, and in severe shock. Proper storage and handling are also essential[5].

Sources

  1. B. Braun USA - Lidocaine Hydrochloride and 5% Dextrose Injection USP.
  2. B. Braun USA - Lidocaine Hydrochloride and 5% Dextrose Injection USP.
  3. GlobeNewswire - Global Lidocaine Hydrochloride Market Report 2024.
  4. DailyMed - Lidocaine Hydrochloride and 5% Dextrose Injection USP.
  5. Baxter - Lidocaine Hydrochloride 0.4% and 5% Dextrose Injection.

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