Last Updated: June 9, 2026

LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Lidocaine Hydrochloride 0.8% In Dextrose 5% In Plastic Container, and what generic alternatives are available?

Lidocaine Hydrochloride 0.8% In Dextrose 5% In Plastic Container is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in LIDOCAINE HYDROCHLORIDE 0.8% 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 0.8% In Dextrose 5% In Plastic Container

A generic version of LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as lidocaine hydrochloride by PHARMOBEDIENT on November 18th, 1982.

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  • What is the 5 year forecast for LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER?
  • What are the global sales for LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER?
Summary for LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER
Recent Clinical Trials for LIDOCAINE HYDROCHLORIDE 0.8% 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 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for LIDOCAINE HYDROCHLORIDE 0.8% 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 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER lidocaine hydrochloride INJECTABLE;INJECTION 018388-003 Nov 5, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 0.8% in Dextrose 5% in Plastic Container

Last updated: March 28, 2026

What are the current market fundamentals for Lidocaine Hydrochloride 0.8% in Dextrose 5%?

Lidocaine Hydrochloride 0.8% in Dextrose 5% is a local anesthetic used primarily for infiltration anesthesia and nerve blocks in medical procedures. Its formulation in a plastic container is standard for single-use vials. The global market for local anesthetics, including lidocaine, is expanding due to rising surgical procedures and increasing demand for outpatient anesthesia.

The global local anesthetics market was valued at approximately USD 2.5 billion in 2022, with a compound annual growth rate (CAGR) of 6% projected through 2030 [1]. Lidocaine accounts for roughly 45% of this market share, making it the most widely used local anesthetic globally.

How does the formulation and packaging impact market adoption?

The 0.8% concentration in dextrose solution aligns with common usage for infiltration anesthesia. The plastic container simplifies storage, reduces costs, and enhances safety for single-use administration.

Packaging compliance is critical, as regulations mandate specific labeling, tamper-evidence, and material safety. The plastic vials meet these standards, facilitating distribution across hospitals and clinics. The standardization of packaging reinforces brand recognition and supports widespread adoption.

What are the key market drivers influencing financial performance?

Increased demand due to procedural volume

Surgeries, dental procedures, and pain management interventions are rising globally. The outpatient setting utilization increase supports higher demand for lidocaine formulations.

Preference for single-use plastic containers

Single-use plastic vials reduce cross-contamination risks and support sterile procedures. The cost-effectiveness and ease of use bolster their preference among healthcare providers.

Regulatory approvals and compliance

Stringent regulations in major markets (FDA, EMA, PMDA) favor formulations with established safety profiles. Compliance accelerates market penetration.

Competitive landscape

Major manufacturers hold supply agreements with hospitals and distributors. Market control is split among global companies like Hospira, Hikma, and local producers in emerging markets.

How does regulation influence market growth?

Regulatory agencies enforce standards relating to sterility, container safety, and labeling. Approved formulations that meet these standards experience fewer market entry barriers. Recent updates to USP and JP standards for injectable products reinforce container safety, potentially increasing compliance costs but also boosting product quality and trust.

What are the financial outlook projections?

Revenue growth

The segment for lidocaine in plastic vials is projected to grow at a CAGR of approximately 6% through 2030, mirroring the overall local anesthetics market.

Price trends

Price erosion is expected due to increased generic competition, especially from manufacturers in India and China, which offer lower-cost alternatives. The average price per vial, initially around USD 1.50 in 2022, may decline to approximately USD 1.10–1.30 by 2030.

Cost considerations

Manufacturing costs in emerging markets are approximately USD 0.20 per unit, with export costs adding USD 0.10. Quality assurance and regulatory compliance costs range between USD 0.05–0.15 per unit.

Investment implications

Manufacturers investing in scalable manufacturing lines and regulatory compliance may realize improved margins despite pricing pressures. Market entry strategies targeting emerging markets could favor profitability owing to lower production costs.

What are competitive risks and opportunities?

Risks

  • Market saturation due to generic proliferation.
  • Regulatory delays or tightening that increase compliance costs.
  • Price competition leading to margin compression.

Opportunities

  • Development of extended-release or combination formulations.
  • Expansion into emerging markets with underserved healthcare infrastructure.
  • Enhancing sterilization and safety features to differentiate products.

Summary table of key data points

Aspect Data
Global local anesthetics market (2022) USD 2.5 billion
Lidocaine's market share 45%
Projected CAGR (2023–2030) 6%
Price per vial (2022) USD 1.50
Expected price decline (2023–2030) 10–15% decrease
Production cost per unit USD 0.20
Regulatory cost per unit USD 0.05–0.15

Key Takeaways

  • The lidocaine hydrochloride 0.8% in dextrose 5% market aligns with ongoing growth in outpatient procedures.
  • Packaging in plastic containers supports cost-effective, sterile delivery, enabling adoption across diverse healthcare settings.
  • Market growth depends heavily on procedural volume, regulatory acceptance, and competition from generics.
  • Prices are expected to decline due to competitive pressures, but profitability can be maintained through scale and innovation.
  • Opportunities exist in emerging markets and formulation enhancements, despite regulatory and pricing challenges.

FAQs

1. How does formulation concentration influence market demand?
The 0.8% concentration provides a standard, effective dose for infiltration anesthesia, widely accepted across healthcare systems, supporting steady demand.

2. What regulatory standards impact packaging safety for this product?
In the US, FDA regulations require sterile, tamper-evident packaging with clear labeling. Similar standards apply in Europe (EMA) and Japan (PMDA).

3. Are there regional differences in market growth?
Yes. North America and Europe lead due to higher procedural volumes, while Asia-Pacific, Latin America, and Africa exhibit higher growth rates driven by increased healthcare access and infrastructure development.

4. What are the main factors affecting pricing trends?
Generic competition, manufacturing costs, and regional pricing policies influence the price per vial.

5. Can innovation in packaging or formulation sustain market share?
Yes. Innovations like prefilled syringes, extended-release formulations, or combination products could provide differentiation and competitive advantages.


References

[1] MarketandMarkets. (2022). Global Local Anesthetics Market. Retrieved from https://www.marketsandmarkets.com

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