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Last Updated: December 12, 2025

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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When do Lidocaine Hydrochloride 0.2% And Dextrose 5% In Plastic Container patents expire, and what generic alternatives are available?

Lidocaine Hydrochloride 0.2% And Dextrose 5% In Plastic Container is a drug marketed by B Braun and Baxter Hlthcare and is included in three NDAs.

The generic ingredient in LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Sixty-one 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 0.2% And Dextrose 5% In Plastic Container

A generic version of LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER was approved as lidocaine hydrochloride by PHARMOBEDIENT on November 18th, 1982.

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Summary for LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
Recent Clinical Trials for LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

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SponsorPhase
Vanderbilt University Medical CenterPHASE4
Assiut UniversityNA
Fundacin Oftalmolgica de Santander Clnica Carlos Ardila LullePHASE1

See all LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

Pharmacology for LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

US Patents and Regulatory Information for LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER lidocaine hydrochloride INJECTABLE;INJECTION 018967-001 Mar 30, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER lidocaine hydrochloride INJECTABLE;INJECTION 019830-002 Apr 8, 1992 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER lidocaine hydrochloride INJECTABLE;INJECTION 018461-002 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Lidocaine Hydrochloride 0.2% and Dextrose 5% in Plastic Container

Last updated: August 5, 2025

Introduction

Lidocaine Hydrochloride 0.2% combined with Dextrose 5% in plastic containers represents a niche yet vital segment within intravenous (IV) anesthesia, regional analgesia, and local anesthetic solutions. These formulations serve multiple clinical applications ranging from minor surgical procedures to pain management, potentiated by their ease of use and compatibility with modern hospital settings. This article explores the evolving market landscape, key drivers, challenges, and financial trends impacting this specific pharmaceutical segment.

Market Overview

Product Profile

Lidocaine Hydrochloride 0.2% combined with Dextrose 5% in a plastic container comprises a local anesthetic agent and an osmotic stabilizer, primarily used for regional anesthesia, nerve blocks, or infiltration anesthesia. The plastic container facilitates safe, sterile, and convenient administration, adaptable to infusion systems and prefilled syringes.

Global Market Size

As of 2023, the global market for local anesthetics, including lidocaine-based formulations, is estimated at approximately USD 2.7 billion, with a compound annual growth rate (CAGR) of around 4.5% over the past five years [1]. Although lidocaine solutions occupy a significant chunk within this space, formulations with specific concentrations (like 0.2%) and in specialized packaging such as plastic containers are gaining traction, especially in North American and European markets.

Niche Application and Growth Potential

The specific formulation of lidocaine 0.2% with dextrose 5% aligns with hospital and outpatient settings, emphasizing safety, ease of handling, and compatibility with infusion devices. Rising adoption in ambulatory surgical centers (ASCs), increased preference for minimally invasive procedures, and the shift toward outpatient anesthesia protocols augment market demand.

Market Drivers

Increasing Number of Surgical Procedures

Global surgical volumes are expanding, driven by aging populations and rising prevalence of chronic conditions like osteoarthritis and cardiac diseases. A report estimates over 300 million surgeries annually worldwide, creating a steady demand for local anesthetic solutions [2].

Growing Adoption of Ambulatory and Outpatient Procedures

With healthcare systems emphasizing cost-effectiveness and patient comfort, outpatient surgeries using ready-to-use anesthetic formulations like lidocaine in plastic containers are becoming preferred. Their compatibility with infusion devices simplifies intraoperative management.

Technological Advancements in Packaging

Transition from glass to plastic containers offers benefits such as reduced breakage, lighter weight, and improved safety. This trend encourages manufacturers to innovate with prefilled, sterile, single-dose plastic containers, meeting regulatory and safety standards.

Regulatory Environment

Stringent regulations emphasizing drug safety, traceability, and sterile packaging stimulate innovation in container design and production processes, fostering market entry and growth opportunities [3].

Expansion into Emerging Markets

Growth in healthcare infrastructure, increasing surgical volumes, and rising awareness about patient safety bolster demand in emerging economies such as China, India, and Brazil, where hospital procurement policies favor disposable plastic containers for infection control.

Market Challenges

Price Competition and Generic Penetration

The dominance of generic formulations like lidocaine solutions limits profit margins and constrains market expansion, particularly in price-sensitive regions.

Regulatory Barriers

Regulatory approvals for new packaging formats or formulations can delay market entry, especially across different jurisdictions with varying standards like the FDA (U.S.), EMA (Europe), or CDSCO (India).

Supply Chain Complexity

Ensuring sterile manufacturing of plastic containers that meet global standards involves complex logistics, quality assurance processes, and significant investment, deterring smaller entrants.

Environmental Concerns

Environmental awareness and regulatory initiatives targeting plastic waste management pose challenges to the manufacturer’s sustainability strategies, potentially affecting packaging choices and costs.

Financial Trajectory

Revenue Streams

The primary revenue stems from sales to hospital systems, outpatient clinics, and pharmaceutical distributors. Innovative packaging and formulation enhancements serve as premium value-adds, aligning with hospital procurement trends favoring safety and convenience.

Cost Factors

Manufacturing costs are influenced by raw materials (lidocaine, dextrose, plastics), sterility assurance, regulatory compliance, and distribution logistics. Costs have fluctuated with plastic raw material prices, especially during global supply chain disruptions [4].

Profitability Outlook

While the segment remains competitive due to extensive generic presence, margins are buoyed by value-added features such as prefilled, ready-to-use plastic containers. Mergers, acquisitions, and strategic alliances among key players—like Hospira (Pfizer), Becton Dickinson, and local regional manufacturers—are expected to shape future profitability.

Market Penetration and Forecasts

The segment is projected to grow at a CAGR of approximately 4% through 2030, driven by increasing procedure volumes and technological innovations in packaging and formulation [1]. Market penetration in Asia-Pacific and Latin America is forecasted to outpace mature markets, driven by healthcare infrastructure investments and rising surgical procedures.

Competitive Landscape

Major industry players include Hospira (now part of Pfizer), Becton Dickinson, Hikma Pharmaceuticals, and local manufacturers, each focusing on expanding production capacity of sterile, plastic-container-based local anesthetics. Patent expirations and generic competition continue to influence competitive dynamics, pushing innovation towards improved safety, ease of administration, and cost efficiency.

Regulatory and Market Opportunities

Emerging regulatory pathways emphasizing prefilled, sterile, single-use containers foster innovation. Governments and health authorities may incentivize formulations that reduce infection risks and improve safety profiles, opening avenues for R&D investments. Moreover, the increasing focus on personalized medicine and regional anesthetic techniques augurs well for tailored formulations like lidocaine 0.2% with dextrose 5% in plastic containers.

Conclusion

The market for Lidocaine Hydrochloride 0.2% and Dextrose 5% in plastic containers is poised for steady growth, driven by global surgical trends, technological innovations in packaging, and expanding healthcare infrastructure, especially in emerging markets. While challenges remain—price competition, regulatory hurdles, and environmental concerns—the segment’s outlook remains positive, supported by continuous innovation and increasing procedural demand.

Key Takeaways

  • The segment benefits from rising global surgical volumes, outpatient procedures, and technological advancements in plastic packaging.
  • Growth is concentrated in emerging markets, fueled by healthcare infrastructure expansion and cost-efficient procurement practices.
  • Innovation in sterile, prefilled plastic containers aligns with safety regulations and hospital preferences, offering competitive advantages.
  • Profitability hinges on balancing manufacturing costs, regulatory compliance, and strategic differentiation.
  • Sustainability concerns may influence future packaging designs, requiring industry adaptation.

FAQs

Q1: What clinical advantages does plastic container packaging offer over traditional glass vials for lidocaine formulations?
A1: Plastic containers reduce breakage risk, are lighter for transportation, facilitate prefilled, sterile, single-dose administration, and enhance safety with tamper-evident features.

Q2: How does the growing demand in emerging markets impact the financial prospects for manufacturers?
A2: Rising healthcare infrastructure investments and procedural volumes in countries like China and India present significant growth opportunities through increased sales volume and market expansion.

Q3: Are there environmental concerns associated with plastic containers for local anesthetic solutions?
A3: Yes, single-use plastic packaging contributes to plastic waste, prompting industry and regulators to explore biodegradable materials and recycling initiatives, which may influence future packaging choices.

Q4: What role do regulatory standards play in the market trajectory of lidocaine 0.2% and dextrose 5% formulations?
A4: Stringent safety, sterility, and packaging standards influence product development, approval timelines, and market entry strategies, shaping competitive dynamics.

Q5: What strategies can manufacturers adopt to enhance profitability in this segment?
A5: Investing in innovative packaging, expanding into emerging markets, emphasizing safety features, and aligning with regulatory trends are key strategies to improve margins and market share.


References

[1] MarketsandMarkets. Local Anesthetics Market by Type, Application, and Region. 2021.

[2] WHO Surgical Statistics, 2020.

[3] U.S. Food and Drug Administration (FDA). Guidance on Packaging Standards for Sterile Drugs. 2019.

[4] Global Plastic Raw Materials Market Report, 2022.

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