You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 18, 2025

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


✉ Email this page to a colleague

« Back to Dashboard


When do Lidocaine Hydrochloride 0.2% In Dextrose 5% In Plastic Container patents expire, and when can generic versions of Lidocaine Hydrochloride 0.2% In Dextrose 5% In Plastic Container launch?

Lidocaine Hydrochloride 0.2% In Dextrose 5% In Plastic Container is a drug marketed by Abbott and Hospira and is included in two NDAs.

The generic ingredient in LIDOCAINE HYDROCHLORIDE 0.2% IN 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% In Dextrose 5% In Plastic Container

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

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER?
  • What are the global sales for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER?
Summary for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
Recent Clinical Trials for LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

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

SponsorPhase
Vanderbilt University Medical CenterPHASE4
Assiut UniversityNA
Sakarya UniversityNA

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

US Patents and Regulatory Information for LIDOCAINE HYDROCHLORIDE 0.2% IN 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
Abbott LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER lidocaine hydrochloride INJECTABLE;INJECTION 018954-001 Jul 9, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER lidocaine hydrochloride INJECTABLE;INJECTION 018388-001 Approved Prior to Jan 1, 1982 DISCN 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% in Dextrose 5% in Plastic Container

Last updated: July 29, 2025


Introduction

Lidocaine Hydrochloride 0.2% in Dextrose 5% encapsulates a pivotal niche within intravenous anesthetic and analgesic therapies. Packaged in plastic containers, this formulation serves critical roles in hospital settings, outpatient clinics, and specialized pain management facilities. The evolving pharmaceutical landscape, driven by technological, regulatory, and demographic forces, influences the market trajectory for this specific formulation.


Market Overview and Composition

Lidocaine is a widely used local anesthetic and antiarrhythmic agent. Intravenous formulations, such as Lidocaine 0.2% in Dextrose 5%, primarily function to manage perioperative pain, treat arrhythmias, and in some cases, offer sedation. The delivery in a plastic container enhances portability, safety, and sterility—factors increasingly prioritized by healthcare providers.

The choice of a 0.2% concentration in a 5% dextrose solution reflects standard dosing protocols for certain clinical indications, balancing efficacy and safety. The plastic packaging complies with modern hospital sterilization processes and minimizes breakage risks.


Market Drivers

1. Rising Incidence of Chronic Pain and Cardiac Arrhythmias

Global increases in chronic pain disorders and cardiovascular diseases (CVD) directly expand the market for lidocaine-based therapies. The World Health Organization estimates CVD affects over 490 million individuals worldwide, with a significant subset requiring antiarrhythmic interventions, including intravenous lidocaine (WHO, 2021).

2. Surge in Surgical Procedures

An expanding volume of surgical interventions necessitates perioperative pain management solutions. The rising adoption of minimally invasive techniques, alongside growing outpatient surgical markets, heightens demand for efficient anesthetic agents. Lidocaine's role as an intravenous adjunct remains critical in these settings.

3. Healthcare Infrastructure Development

Emerging markets investing in healthcare infrastructure exhibit increased procurement of injectable pharmaceuticals, including lidocaine formulations. Conversely, advanced economies focus on drug safety and convenience, favoring pre-packaged, single-dose plastic containers aligned with infection control standards.

4. Regulatory Environment and Production Trends

Enhanced regulatory frameworks w.r.t. sterile packaging and drug stability bolster demand for pre-filled plastic containers. Furthermore, the benefit of reduced preparation errors makes these formulations preferable.

5. Growing Focus on Patient Safety and Convenience

Plastic containers provide improved safety features such as tamper-evidence and spill containment, motivating healthcare providers' preference, further amplifying their market share.


Market Restraints and Challenges

1. Competition from Alternative Formulations

Lidocaine is available in various formulations—injectable vials, ampoules, and infusion bags—often with interchangeable applications. The market share for plastic container-based solutions depends on clinical preferences and regulatory approvals, potentially limiting growth if alternative forms dominate.

2. Price Sensitivity and Cost Pressures

Healthcare settings, especially in emerging markets, operate under cost constraints. Plastic pre-filled containers often command higher manufacturing and procurement costs compared to traditional glass vials, which could slow adoption.

3. Regulatory Variability and Approval Delays

Stringent authorization processes and regional regulatory disparities may impede rapid market expansion, particularly in developing regions.

4. Environmental Concerns

Increasing scrutiny over plastic waste and sustainability practices might influence manufacturers to develop eco-friendlier packaging solutions, potentially impacting future product lines.


Financial Trajectory and Market Forecast

The forecast for the Lidocaine 0.2% in Dextrose 5% market in plastic containers suggests steady growth with compound annual growth rate (CAGR) projections around 5-7% over the next five years (2023–2028). This projection considers:

  • Market Expansion in Asia-Pacific and Latin America: These regions exhibit higher growth due to infrastructural investments and rising disease burdens.

  • Innovation in Packaging and Formulations: The integration of smart packaging, stability improvements, and multipurpose containers could justify premium pricing and boost revenues.

  • Emerging Use-Cases: Recent research exploring lidocaine for neuropathic pain and localized analgesia may unlock new demand sectors, benefiting sales of injectable formulations.

  • COVID-19 Pandemic Impact: While initially disrupting supply chains, heightened emphasis on critical care medications has underlined the importance of readily available intravenous drugs, including lidocaine formulations.

Revenue estimates currently place the global market for lidocaine injectable formulations at approximately USD 1.2 billion in 2023, with a sizable proportion attributable to pre-filled plastic containers, projected to reach USD 1.9 billion by 2028.


Regional Market Insights

Region Market Trends Growth Drivers Challenges
North America Mature market, high adoption rates Advancements in surgical techniques, aging population Cost containment, regulatory complexities
Europe Moderate growth, emphasis on safety Strict regulatory environment, focus on patient safety Pricing pressures, environmental regulations
Asia-Pacific Rapid growth, expanding healthcare infrastructure Rising per capita healthcare spend, increasing surgery volume Supply chain constraints, regulatory variances
Latin America & MEA Growing markets, emerging healthcare systems Increasing access, government initiatives in health Infrastructure limitations, procurement challenges

Competitive Landscape

Major pharmaceutical companies and regional manufacturers are increasing investments in injectable formulations of lidocaine in pre-filled plastic containers. Notable players include Hospira (Pfizer), Fresenius Kabi, and local generics manufacturers, positioning themselves via:

  • Product Innovation: Enhanced stability, compatibility, and safety features.
  • Pricing Strategies: Competitive pricing to penetrate cost-sensitive markets.
  • Regulatory Approvals: Accelerating approvals in emerging markets.
  • Strategic Partnerships: Collaborations with hospitals and healthcare providers for exclusive supply contracts.

Emerging biosimilar and generic players are also disrupting traditional markets, contributing to price competition and expanded access.


Regulatory and Compliance Considerations

Compliance with Good Manufacturing Practices (GMP), serialization, and labeling is imperative for market sustainability. Regulatory agencies such as the FDA, EMA, and regional health authorities enforce strict standards, requiring manufacturers to demonstrate batch consistency, container integrity, and stability data specific to plastic pre-filled forms.

Adherence to environmental disposal regulations is increasingly influencing packaging material choices, compelling innovation toward biodegradable plastics or recyclable options.


Key Factors Influencing Market Growth

  • Demographic Shift: Aging populations drive increased demand for analgesic and antiarrhythmic treatments.
  • Clinical Practice Trends: Adoption of intravenous protocols that favor ready-to-use plastic containers.
  • Technological Innovations: Smart packaging offering real-time performance monitoring and enhanced safety.
  • Policy and Reimbursement: Favorable reimbursement policies in developed regions support broader adoption.
  • Global Health Initiatives: Programs aimed at improving perioperative and critical care access expand potential markets.

Key Takeaways

  • The market for Lidocaine Hydrochloride 0.2% in Dextrose 5%, in plastic containers, is poised for steady growth driven by technological advancements, demographic shifts, and expanding healthcare infrastructure.
  • Industry players should focus on innovation in packaging, regulatory compliance, and strategic geographical expansion to capture emerging opportunities.
  • Pricing strategies, environmental considerations, and safety features will increasingly influence market competitiveness.
  • The rising preference for pre-filled, sterile, single-use containers in clinical workflows aligns well with market demands.
  • Stakeholders should monitor regional regulatory developments and healthcare policy changes to optimize market entry and expansion strategies.

FAQs

1. What are the primary clinical applications of Lidocaine 0.2% in Dextrose 5%?
Primarily used for intravenous administration in perioperative pain management, treatment of cardiac arrhythmias, and sometimes for localized analgesia, offering rapid onset and predictable pharmacokinetics.

2. Why is plastic container packaging preferred over glass for this formulation?
Plastic containers reduce breakage risk, are lightweight for portability, facilitate pre-filled single-dose administration, and enhance safety and sterility, aligning with modern clinical practices.

3. How does regional regulation influence the market for this formulation?
Stringent approval processes and differing standards across regions can delay product launches and impact market penetration. Regions with active regulatory pathways for injectable drugs facilitate quicker adoption.

4. What innovations are expected to shape the future of this market?
Smart packaging with stability indicators, biodegradable plastics, increased focus on environmental sustainability, and formulation enhancements for extended shelf life and safety.

5. What strategic considerations should manufacturers prioritize?
Investing in regulatory compliance, expanding into high-growth emerging markets, differentiating through safety features, and adopting environmentally sustainable packaging will be critical.


Conclusion

The market for Lidocaine Hydrochloride 0.2% in Dextrose 5%, packaged in plastic containers, is characterized by resilience and growth potential grounded in clinical demand, technological advances, and modernization of healthcare infrastructure. Companies that align their innovation, regulatory strategies, and environmental commitments with market trends are positioned to capitalize on this sustained trajectory.


References:

[1] World Health Organization. (2021). Cardiovascular Diseases Fact Sheet.
[2] MarketResearch.com. (2023). Global Injectable Pharmaceuticals Market Report.
[3] U.S. Food and Drug Administration (FDA). Guidance Documentation on Injectable Drug Packaging.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.