LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

When do Lidocaine Hydrochloride 0.4% In Dextrose 5% In Plastic Container patents expire, and when can generic versions of Lidocaine Hydrochloride 0.4% In Dextrose 5% In Plastic Container launch?

Lidocaine Hydrochloride 0.4% In Dextrose 5% In Plastic Container is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Fifty-four 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% In Plastic Container

A generic version of LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as lidocaine hydrochloride by PHARMOBEDIENT on November 18^th, 1982.

Summary for LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	2,146
DailyMed Link:	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER

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

Sponsor	Phase
Vanderbilt University Medical Center	PHASE4
Assiut University	NA
Sakarya University	NA

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

US Patents and Regulatory Information for LIDOCAINE HYDROCHLORIDE 0.4% 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
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

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

Last updated: February 16, 2026

Market Size and Growth Drivers

The global local anesthetic market, valued at approximately $3.2 billion in 2022, expects compound annual growth (CAGR) of 4.3% through 2028, driven by increasing surgical procedures where lidocaine is a standard anesthetic agent. Lidocaine hydrochloride specifically is used in both regional anesthesia and cardiac rhythm management. The segment for formulations in dextrose solutions remains niche but growing, owing to particular healthcare protocol needs for quick administration and stability.

Segment Overview

• Product Composition: Lidocaine 0.4% in Dextrose 5%—a combination mainly used for IV regional anesthesia or anesthesia adjuncts.
• Container Type: Plastic (PVC or non-PVC infusion bags).

Pricing and Revenue

Pricing for lidocaine solutions varies globally. In the U.S., a 50 mL vial of lidocaine hydrochloride 0.4% in dextrose costs between $15 and $25. The per-unit revenue for a standard 50 mL bag can range from $15 to $25, with annual sales volumes dependent on hospital procurement rates, usage guidelines, and local regulatory approvals.

Regulatory Environment

• FDA and EMA Approvals: The formulation with 0.4% lidocaine and dextrose is not novel but is subject to strict approval pathways. The U.S. Food and Drug Administration (FDA) classifies this as a compounded or licensed injectable product.
• Unique Manufacturing Standards: Plastic containers must meet USP, EP, or JP standards for plasticizers, leachables, and extractables to prevent contamination.

Market Entry Barriers

• Regulatory Hurdles: Approvals depend on demonstrating sterility, stability, and safety.
• Manufacturing Complexity: Ensuring batch-to-batch consistency in plastic container closure and solution stability.
• Reimbursement and Pricing Pressure: Healthcare payers push for lower costs, especially in outpatient and hospital settings.

Technological and Competitive Landscape

• Major Manufacturers: Pfizer, Hikma Pharmaceuticals, and Baxter International dominate with licensed formulations.
• Generic Competition: The market has high generic penetration, resulting in price erosion.
• Innovation Trends: Development of preservative-free formulas and pre-filled syringes.

Distribution and Sales Channels

• Mainly hospital pharmacies, outpatient clinics, and emergency services.
• Increasing adoption in outpatient procedures due to minimally invasive surgical techniques.

Financial Trajectory

• Current Revenue: Estimated at $150 million globally in 2022.
• Growth Outlook: Based on the CAGR, revenues could approach $200 million by 2028.
• Profitability Factors: Margins are compressed, with average gross margins around 40-50% due to commoditization and pricing pressure.
• Emerging Factors: Increased adoption in ambulatory surgical centers and expanded indications could improve top-line figures.

Key Risks

• Regulatory delays or reclassification.
• Competition from alternative anesthetic agents (e.g., bupivacaine).
• Price suppression due to generic proliferation.

Partnership Opportunities

• Co-development with custom plastic container manufacturers.
• Licensing deals with regional pharmaceutical companies to penetrate emerging markets.

Summary

The market for lidocaine hydrochloride 0.4% in dextrose 5% in plastic containers remains stable but highly competitive, influenced by regulation, pricing, and hospital procurement dynamics. Revenue growth aligns with the broader anesthetic market expansion, with a projected increase in global sales driven by outpatient and minimally invasive procedures.

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Key Takeaways

• The overall local anesthetic market is expanding at a CAGR of 4.3%, with lidocaine occupying a significant share.
• The formulation discussed is primarily used in hospital and outpatient settings, priced around $15–$25 per 50 mL unit.
• Competitive landscape includes major pharmaceutical firms and generic manufacturers, creating pricing pressures.
• Regulatory compliance and manufacturing standards in plastic containers are critical barriers to market entry.
• Revenue is forecasted to grow modestly, reaching approximately $200 million globally by 2028.

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FAQs

1. What are the main factors influencing the pricing of lidocaine solutions in plastic containers?
   Regulatory compliance, manufacturing costs, competition, and healthcare reimbursement policies affect price points.

2. How does the regulatory environment impact new entrants into this market segment?
   New entrants face lengthy approval processes, requiring demonstration of safety, efficacy, and manufacturing quality, often delaying market entry.

3. What competitive threats exist besides generic competition?
   Alternative anesthetic agents like bupivacaine and regional anesthetics with longer duration or fewer side effects pose threats.

4. Are there emerging markets for this formulation?
   Yes, regions with expanding healthcare infrastructure, such as Asia-Pacific, present growth opportunities due to increasing surgical procedures.

5. What technological innovations could influence future sales trajectories?
   Pre-filled plastic syringes, preservative-free formulations, and stability-enhanced containers could drive adoption.

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Sources

[1] MarketsandMarkets, “Local Anesthetics Market by Drug Class, Application, & Region,” 2022.
[2] IQVIA, “Pharmaceutical Market Data,” 2022.
[3] U.S. FDA, “Instructions for Industry: Container Closure Inspection,” 2022.
[4] EvaluatePharma, “Global Generic Drug Market Outlook,” 2022.