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

Which patents cover Lidocaine Hydrochloride 0.2% And Dextrose 5% In Plastic Container, and when can generic versions of Lidocaine Hydrochloride 0.2% And Dextrose 5% In Plastic Container launch?

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. 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 0.2% 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 18^th, 1982.

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

US Patents:	0
Applicants:	2
NDAs:	3

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
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
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

Investment Scenario and Fundamentals Analysis for Lidocaine Hydrochloride 0.2% and Dextrose 5% in Plastic Container

Last updated: February 21, 2026

Market Overview

Lidocaine hydrochloride 0.2% with dextrose 5% is a local anesthetic solution used primarily in medical procedures requiring localized pain management, and as a component in intravenous (IV) therapy for anesthesia. The global demand is driven by ongoing needs in surgical, dental, and emergency medicine settings. The market size for lidocaine solutions was valued at approximately USD 1 billion in 2021, with a compound annual growth rate (CAGR) forecast of around 4% through 2028 [1].

The segment of lidocaine formulations in plastic containers benefits from regulatory approval trends favoring pre-filled, ready-to-use devices. This aligns with hospital and outpatient preferences for safety, sterility, and convenience.

Product Composition and Regulatory Status

Product Specifications:

• Active Ingredient: Lidocaine hydrochloride, 0.2%
• Additive: Dextrose, 5%
• Container: Plastic (polyethylene or polycarbonate), typically IV bag or syringe

Regulatory Considerations:

• Approved in major markets, including the US (FDA), EU (EMA), and Japan (PMDA), under various indications.
• Eligible for existing generic and branded formulations, with patent expiries for many molecules in recent years, increasing generics competition.
• Must meet standards per US Pharmacopoeia (USP) or European Pharmacopoeia (Ph. Eur.).

Competitive Landscape

Company	Market Share	Key Approvals	Pricing Level
Hospira (Pfizer)	~25%	FDA-approved	Moderate
Baxter	~15%	FDA, EMA	Moderate
Sandoz	~10%	FDA, EMA	Low
Other generics	~50%	Various	Low

Key competitors focus on manufacturing in the US, EU, and Asian markets, leveraging existing supply chains for rapid distribution.

Manufacturing and Cost Dynamics

Manufacturing Costs:

• Raw Materials: Lidocaine hydrochloride (~ USD 200/kg), Dextrose (~ USD 0.50 per gram)
• Filling & Packaging: USD 0.10–0.20 per unit
• Regulatory compliance and clinical trials cost: substantial upfront, reduced in later generations.

Pricing and Margins:

• Market retail price ranges from USD 2 to 5 per 100 mL unit.
• Cost of goods sold (COGS): estimated at USD 0.05–0.15 per unit for generics.
• Gross margins: 60–80% are typical for branded players; generics operate around 20–40%.

Investment Risks and Challenges

• Regulatory hurdles: Delays in approval, especially for new formulations or delivery devices.
• Pricing pressures: Increased competition among generics, government-mandated price reductions.
• Manufacturing constraints: Strict quality standards, potential supply chain disruptions for raw materials.
• Patent expiries: Time-sensitive opportunity for generic entry.

Investment Indicators

Indicator	Data Point	Implication
Market Growth Rate	4% CAGR (2021–2028)	Stable expansion potential
Patent Status	Many patent expiries post-2015	High opportunity for generics
Regulatory Barriers	Moderate to high	Longer time-to-market in some regions
Distribution Channels	Hospitals, clinics	Dependence on healthcare sector stability

Financial Projections and Strategy

• Short-term (0–3 years): Focus on FDA/EMA approval of new generic formulations, reducing manufacturing costs, expanding distribution.
• Medium-term (3–5 years): Scale-up production, entering emerging markets, diversifying into other lidocaine-based products.
• Long-term (5+ years): Develop extended-release or combination formulations, leverage patent protections or exclusivity periods.

Key Takeaways

• The product segment is mature with ongoing demand, driven by hospital use and procedural needs.
• Asset value hinges on regulatory approval, manufacturing efficiency, and market access.
• Competition is intense among generics, putting pressure on prices and margins.
• Opportunities exist for mid-sized players with scalable manufacturing and regulatory expertise.
• Risks include pricing pressures, supply chain disruptions, and slow approvals.

FAQs

1. What is the main market driver for lidocaine 0.2% with dextrose 5%?
The primary driver is its widespread use in local anesthesia and IV therapy in hospitals and outpatient clinics.

2. How does patent expiry influence investment opportunities?
Patent expiries open the market for generics, increasing competition but also creating opportunities for new entrants to capture market share.

3. What regulatory hurdles could impact product launch?
Regulatory agencies require comprehensive safety and efficacy data, and manufacturing facilities must meet strict quality standards, potentially leading to delays.

4. How does pricing pressure affect profitability?
Pricing reductions from hospitals and government payers compress margins, especially on commodity or highly competitive formulations.

5. What factors contribute to manufacturing costs?
Raw material prices, facility compliance, scale of production, and quality control processes are key cost components.

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References

[1] MarketWatch. (2022). "Global Lidocaine Market Size, Share & Trends Analysis Report." MarketWatch. https://www.marketwatch.com

[2] IQVIA. (2021). "Global Injectable Market Analysis." IQVIA. https://www.iqvia.com