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Last Updated: December 19, 2025

XYLOCAINE 5% W/ GLUCOSE 7.5% Drug Patent Profile


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When do Xylocaine 5% W/ Glucose 7.5% patents expire, and what generic alternatives are available?

Xylocaine 5% W/ Glucose 7.5% is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in XYLOCAINE 5% W/ GLUCOSE 7.5% 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 Xylocaine 5% W/ Glucose 7.5%

A generic version of XYLOCAINE 5% W/ GLUCOSE 7.5% was approved as lidocaine hydrochloride by PHARMOBEDIENT on November 18th, 1982.

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Summary for XYLOCAINE 5% W/ GLUCOSE 7.5%
Drug patent expirations by year for XYLOCAINE 5% W/ GLUCOSE 7.5%
Recent Clinical Trials for XYLOCAINE 5% W/ GLUCOSE 7.5%

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SponsorPhase
Centre hospitalier de l'Université de Montréal (CHUM)Phase 4
The University of Texas Health Science Center at San AntonioPhase 4

See all XYLOCAINE 5% W/ GLUCOSE 7.5% clinical trials

US Patents and Regulatory Information for XYLOCAINE 5% W/ GLUCOSE 7.5%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca XYLOCAINE 5% W/ GLUCOSE 7.5% lidocaine hydrochloride INJECTABLE;SPINAL 010496-002 Jul 7, 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 XYLOCAINE 5% W/ GLUCOSE 7.5%

Last updated: August 23, 2025


Introduction

XYLOCAINE 5% W/ GLUCOSE 7.5% represents a specialized pharmaceutical formulation primarily indicated for local anesthesia coupled with an energy supplement. Historically, such formulations have gained prominence within outpatient dental, surgical, and pain management sectors. This document evaluates current market dynamics, anticipated financial trajectories, and strategic considerations affecting XYLOCAINE 5% W/ GLUCOSE 7.5%, providing stakeholders with a comprehensive outlook on future growth and investment potential.


Product Overview and Therapeutic Relevance

XYLOCAINE, known generically as lidocaine, is a widely used local anesthetic. The addition of glucose at a concentration of 7.5% aims to facilitate energy provision during procedures, notably benefiting patients undergoing lengthy or intensive interventions. Its dual functionality as an anesthetic and energy source enhances its clinical utility, particularly in settings demanding rapid, effective sedation coupled with metabolic support.

The formulation's relevance extends across multiple sectors, including dental practices, outpatient surgical clinics, emergency medicine, and military or remote settings where simultaneous analgesia and energy provision are critical.


Market Drivers

1. Increasing Demand for Local Anesthetics

Global dental and surgical markets are expanding, driven by rising cases of dental caries, oral health awareness, and minimally invasive procedures. As per the World Health Organization (WHO), the global burden of dental diseases is on the rise, underpinning increased consumption of local anesthetics such as XYLOCAINE.

2. Growth in Emergency and Remote Medical Care

Remote and emergency care settings increasingly leverage formulations like XYLOCAINE with glucose to optimize patient outcomes—reducing procedure time and improving comfort. Military and field medicine applications also favor such formulations due to their ease of administration and multifunctionality.

3. Rising Preference for Combination Formulations

Combination anesthetic formulations that include energy substrates like glucose are gaining favor to mitigate hypoglycemia or energy deficits during lengthy procedures, bolstering demand for products like XYLOCAINE 5% W/ GLUCOSE 7.5%.

4. Regulatory and Policy Environment

Stringent safety and efficacy standards in developed markets promote innovations that combine multiple functionalities within a single formulation, positioning XYLOCAINE with glucose advantageously under new drug approvals and guidelines (e.g., FDA, EMA).


Market Challenges

1. Competition from Established Anesthetics

Generic lidocaine solutions and alternative anesthetic agents like articaine and ropivacaine pose significant market competition. These formulations are often less complex and cost-effective, potentially undercutting specialty products.

2. Limited Awareness and Adoption

Clinical familiarity and prescription prevalence for XYLOCAINE 5% W/ GLUCOSE specifically remains limited outside niche markets, requiring targeted educational and marketing strategies to expand reach.

3. Cost and Affordability Constraints

Combination formulations with added glucose may incur higher manufacturing costs, potentially elevating prices. Cost-sensitive markets might therefore prefer traditional formulations or alternatives, impacting sales volumes.

4. Regulatory Hurdles

Navigating diverse regulatory pathways, especially for combination products with added glucose, entails extensive clinical trials, which can delay market entry or expansion.


Financial Trajectory and Market Projections

1. Market Size and Growth Estimations

The global local anesthetic market is projected to reach USD 4.2 billion by 2027, expanding at a compound annual growth rate (CAGR) of approximately 4%, driven by increased dental procedures and surgical interventions [1].

Given its niche positioning, XYLOCAINE 5% W/ GLUCOSE is expected to constitute a segment of this growth, estimated conservatively at 2-3% of the total local anesthetic market, translating to a potential revenue stream of USD 84-126 million in the coming years.

2. Regional Opportunities

North America and Europe dominate the market due to advanced healthcare infrastructure, regulatory support, and high procedural volumes. Emerging markets in Asia-Pacific and Latin America are poised for rapid growth owing to increasing healthcare penetration and urbanization, offering lucrative opportunities for regional expansion.

3. Revenue Forecasting

Assuming moderate market penetration and adoption rates, revenues could increase from initial annual sales estimates of USD 10-20 million in early deployment phases to USD 40-50 million within 5 years, contingent on successful regulatory approval, clinical acceptance, and distribution channel expansion.

4. Pricing Strategy

Premium positioning owing to unique formulation features suggests that unit prices could be 15-20% higher than standard lidocaine solutions. Volume sales expansion will be instrumental in offsetting higher product costs and establishing profitability.

5. Investment and Cost Considerations

Research and development costs related to clinical trials, regulatory approval, and manufacturing scale-up will impact initial profitability. Strategic partnerships with established pharmaceutical firms could mitigate entry barriers and accelerate market penetration.


Strategic Opportunities and Market Entry Considerations

  • Partnerships with Dental and Surgical Chains: To maximize adoption among practitioners, forging alliances with clinical networks can facilitate product acceptance.

  • Regulatory Pathways: Streamlining approval processes via orphan drug designation or fast-track pathways, where applicable, can reduce time-to-market.

  • Formulation Optimization: Ensuring stability, ease of administration, and compatibility across various delivery formats (vials, pre-filled syringes) enhances market appeal.

  • Educational Campaigns: Highlighting clinical benefits of the formulation—combining anesthesia with metabolic support—can influence prescribing behaviors.


Conclusion

XYLOCAINE 5% W/ GLUCOSE 7.5% occupies a strategic niche within the local anesthetic landscape, with promising market growth driven by expanding procedural volumes and unique therapeutic advantages. Although faced with competition and regulatory challenges, targeted market strategies, regional expansion, and clinical acceptance can foster a strong financial trajectory in the forthcoming years.


Key Takeaways

  • Growing Demand: The global rise in minimally invasive procedures and outpatient surgeries propels the need for effective local anesthetic formulations like XYLOCAINE with glucose support.

  • Niche Market Position: While competing with traditional anesthetics, the combined formulation offers differentiating benefits, especially in emergency and remote settings.

  • Regional Growth Potential: North America and Europe remain primary markets, but Asia-Pacific and Latin America present significant expansion opportunities.

  • Pricing and Cost Strategy: Premium pricing aligned with added therapeutic value, coupled with manufacturing efficiency, will enhance profitability.

  • Regulatory and Clinical Adoption: Success hinges on navigating regulatory pathways and educating clinicians on the benefits of combined anesthetic-metabolic formulations.


FAQs

1. What are the primary therapeutic advantages of XYLOCAINE 5% W/ GLUCOSE 7.5%?
It combines local anesthesia with an energy substrate, supporting metabolic needs during procedures, thereby enhancing patient comfort and potentially reducing recovery time.

2. How does the market for XYLOCAINE with glucose compare to standard lidocaine formulations?
While standard lidocaine remains dominant due to its established efficacy and lower cost, formulations with added glucose target niche applications demanding combined analgesic and metabolic support.

3. Which regions represent the most promising growth opportunities for this formulation?
North America and Europe lead in adoption, but Asia-Pacific and Latin America offer high-growth potential due to increasing healthcare investments and procedural volumes.

4. What are the main challenges to the commercial success of XYLOCAINE 5% W/ GLUCOSE?
Challenges include competition from established anesthetics, regulatory hurdles, higher manufacturing costs, and limited clinician awareness.

5. What strategies could accelerate market adoption?
Engaging clinical influencers, establishing strategic partnerships, optimizing formulations for ease of use, and targeted educational campaigns can enhance acceptance and sales.


References

[1] MarketsandMarkets, "Local Anesthetics Market by Product (Lidocaine, Bupivacaine), Application, and Region — Global Forecast to 2027," 2022.

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