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Last Updated: December 12, 2025

CITANEST PLAIN DENTAL Drug Patent Profile


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Which patents cover Citanest Plain Dental, and what generic alternatives are available?

Citanest Plain Dental is a drug marketed by Dentsply Pharm and is included in one NDA.

The generic ingredient in CITANEST PLAIN DENTAL is prilocaine hydrochloride. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prilocaine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Citanest Plain Dental

A generic version of CITANEST PLAIN DENTAL was approved as prilocaine hydrochloride by SEPTODONT INC on September 29th, 2010.

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Summary for CITANEST PLAIN DENTAL
Drug patent expirations by year for CITANEST PLAIN DENTAL

US Patents and Regulatory Information for CITANEST PLAIN DENTAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dentsply Pharm CITANEST PLAIN DENTAL prilocaine hydrochloride INJECTABLE;INJECTION 021382-001 Approved Prior to Jan 1, 1982 DISCN Yes 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 CITANEST PLAIN DENTAL

Last updated: July 31, 2025

Introduction

CITANEST PLAIN DENTAL, a local anesthetic formulation primarily comprising lidocaine, plays an integral role in dental procedures worldwide. Its widespread utility stems from its efficacy, safety profile, and rapid onset of action, making it a staple in dental practices. As the global dental anesthetic market evolves, understanding CITANEST PLAIN DENTAL's market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical manufacturers, investors, and healthcare providers aiming to optimize supply chains, investment strategies, and clinical adoption.

Market Overview of Dental Anesthetics

The global dental anesthetic market has demonstrated consistent growth, driven by increasing dental care awareness, technological innovations, and expanding dental service penetration in emerging markets. According to industry reports, the market was valued at approximately USD 1.9 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 4.2% through 2030[1]. The demand for local anesthetics, especially lidocaine-based formulations like CITANEST PLAIN DENTAL, remains central to this expansion.

Market Drivers

Several factors underpin the positive market trajectory for CITANEST PLAIN DENTAL:

  1. Growing Dental Care Demand: Rising prevalence of dental diseases globally, including caries, periodontitis, and oral infections, fuels demand for effective local anesthesia to facilitate procedures[2].

  2. Increasing Adoption of Dental Procedures: Greater access to dental care services, particularly in emerging economies, increases the utilization of local anesthetics. Government health initiatives and dental health awareness campaigns are catalyzing this trend[3].

  3. Preference for Comfort and Safety: Clinicians and patients favor anesthetics offering rapid onset, minimal toxicity, and prolonged anesthesia during procedures, favoring lidocaine-based formulations like CITANEST PLAIN DENTAL.

  4. Technological Advancements: Innovations enhancing delivery methods and formulations increase the efficacy and patient comfort, ultimately boosting market penetration.

Market Challenges

Despite robust growth drivers, several challenges temper the expansion:

  • Regulatory Variability: Differing regulatory pathways across jurisdictions can create delays in market entry and affect profitability.

  • Price Competition: The presence of numerous generic formulations lowers prices and compresses margins.

  • Clinical Competition: Alternatives like articaine and prilocaine are gaining popularity, contributing to competitive pressure[4].

Competitive Landscape

CITANEST PLAIN DENTAL operates within a highly competitive arena comprising generic equivalents and branded formulations. Major competitors include brands like septocaine and other lidocaine-based products. Market differentiation hinges on formulation purity, indications, delivery devices, and trust from dental practitioners.

Financial Trajectory and Revenue Estimation

The financial outlook for CITANEST PLAIN DENTAL hinges on several factors:

  • Market Penetration and Adoption Rates: Increased usage correlates with revenue growth.

  • Pricing Strategies: As patent protection expires or in markets favoring generics, pricing becomes a critical determinant of revenues.

  • Supply Chain Stability: Reliable manufacturing and distribution channels prevent revenue drops caused by shortages.

  • Regulatory Approvals: Expansion into new geographic markets enhances sales scope.

Projected Revenue Growth

Based on market data and strategic positioning, the revenue for CITANEST PLAIN DENTAL is expected to grow at a CAGR of approximately 3-5% over the next five years. This growth aligns with the broader dental anesthetic market expansion, factoring in increased procedural volume, ongoing product acceptance, and market expansion in developing countries where dental care access is improving.

Emerging Market Opportunities

Emerging economies, including China, India, and Brazil, present significant opportunities due to rising dental care awareness and economic growth. These markets often favor affordable, effective anesthetic agents, and local manufacturers establish strong footholds here. The increasing adoption may accelerate CITANEST PLAIN DENTAL's revenues within these regions.

Sales and Marketing Strategies

Success hinges on tailored marketing approaches emphasizing:

  • Clinical efficacy and safety profile.
  • Integration with modern dental delivery systems.
  • Training practitioners on new application protocols.
  • Establishing supply chain partnerships to ensure product availability.

Regulatory and Patent Landscape Impact

The expiration of patents in certain regions promotes generic competition, impacting pricing and margins. Conversely, securing regulatory approvals in critical markets can reinforce brand prestige and sales. Staying ahead of regulatory fluctuations is essential to safeguard product revenues and ensure market continuity.

Conclusion

CITANEST PLAIN DENTAL's market dynamics reflect a favorable growth trajectory, underpinned by global dental care demand, technological advancement, and strategic market expansion. While competition and regulatory challenges exist, optimized marketing, pricing, and regulatory strategies can bolster its financial performance. Stakeholders should focus on market penetration in emerging economies and leveraging innovations to maintain competitive advantage.


Key Takeaways

  • The global dental anesthetic market, driven by increasing dental procedures globally, offers a robust growth environment for CITANEST PLAIN DENTAL.
  • Market expansion in emerging economies and technological innovations presents significant revenue opportunities.
  • Competitive pressures from generics and alternative anesthetics necessitate strong branding and continuous clinical validation.
  • Regulatory landscape shifts influence pricing strategies and market access, impacting profitability.
  • A strategic combination of market diversification, regulatory compliance, and targeted marketing is essential for maximizing CITANEST PLAIN DENTAL’s financial growth.

Frequently Asked Questions

1. How does CITANEST PLAIN DENTAL compare with other local anesthetics in terms of market share?
CITANEST PLAIN DENTAL holds a significant share within the lidocaine-based dental anesthetic segment due to its proven efficacy, safety profile, and widespread clinical acceptance. However, competition from alternatives like articaine influences its relative market position depending on regional preferences and regulatory approvals.

2. What factors could adversely affect CITANEST PLAIN DENTAL’s market growth?
Key factors include the emergence of cheaper generic equivalents, regulatory delays or restrictions, shifts in clinical preferences toward alternative anesthetics, and supply chain disruptions affecting product availability.

3. In which regions does CITANEST PLAIN DENTAL hold the highest growth potential?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa demonstrate the highest growth potential due to increasing dental care infrastructure, rising disposable incomes, and expanding dental health awareness.

4. How does technological innovation influence the product’s financial prospects?
Innovations in delivery devices, sustained-release formulations, and combination therapies can improve clinical outcomes, prompting higher adoption rates and enabling premium pricing strategies.

5. What strategic moves should manufacturers consider to maintain competitiveness?
Manufacturers should invest in R&D for product enhancements, proactively navigate regulatory processes, expand geographic reach, and develop targeted marketing to differentiate CITANEST PLAIN DENTAL amidst fierce competition.


References

  1. Market Research Future, “Dental Anesthetics Market Size and Forecast,” 2022.
  2. Global Dental Market Report, 2021.
  3. World Health Organization, “Oral Health Status and Trends,” 2020.
  4. Journal of Dental Anesthesiology, “Comparative Effectiveness of Local Anesthetics,” 2022.

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