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Last Updated: March 26, 2026

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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Questions you can ask:
  • What is the 5 year forecast for CITANEST PLAIN DENTAL?
  • What are the global sales for CITANEST PLAIN DENTAL?
  • What is Average Wholesale Price for CITANEST PLAIN DENTAL?
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 ⤷  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 CITANEST PLAIN DENTAL

Last updated: February 25, 2026

What is the current market positioning of CITANEST PLAIN DENTAL?

CITANEST PLAIN DENTAL, with the active ingredient lidocaine (2%), is a locally administered anesthetic used primarily for dental procedures. It commands a significant share of the dental anesthesia market due to its established safety profile and effectiveness. Key competitors include prilocaine, articaine, and mepivacaine.

Market penetration is highest in North America and Europe, where dental practices prioritize proven anesthetic agents. In emerging markets, growth is driven by increasing dental care awareness and expanding healthcare infrastructure.

How has the demand for CITANEST PLAIN DENTAL evolved recently?

Demand growth correlates with an upward trend in dental procedures globally, including restorative, cosmetic, and implant surgeries. The global dental market is projected to grow at a compound annual growth rate (CAGR) of approximately 6% from 2023 to 2028 (Research and Markets, 2022). Specifically, dental anesthesia products like CITANEST PLAIN DENTAL benefit from this expansion.

The demand is further supported by patient preference for minimal discomfort, which boosts the sales of reliable local anesthetics. During the COVID-19 pandemic, elective dental procedures declined initially but rebounded quickly as restrictions eased, supporting demand resumption.

What are the key drivers influencing the financial trajectory?

Market Growth

The expanding global dental industry fuels sales. The prevalence of dental disorders, increased public health initiatives, and technological advancements in dental procedures drive increased consumption of anesthetics.

Regulatory Environment

Regulations governing dental anesthetic agents are stable in major markets, with approval processes handled by FDA (U.S.), EMA (Europe), and corresponding agencies. Regulatory approval timelines influence the market entry of alternative products.

Competitive Landscape

CITANEST PLAIN DENTAL faces competition from generic lidocaine products and new formulations. The market favors agents with rapid onset, longer duration, and low toxicity—areas where CITANEST performs well.

Pricing and Reimbursement

Pricing strategies influence profitability; in developed markets, insurance reimbursement supports higher pricing tiers. In lower-income regions, price sensitivity may restrict margins.

Innovations and Formulation Enhancements

Introduction of sustained-release formulations or combination products could impact future sales. Currently, CITANEST remains a standard formulation with limited innovations.

What are the financial forecasts for CITANEST PLAIN DENTAL?

Specific financial data are proprietary and often not disclosed publicly. However, based on market trends, global dental anesthesia sales are estimated at approximately USD 1.5 billion annually, growing at 6% CAGR (Research and Markets, 2022).

If CITANEST PLAIN DENTAL sustains a 10-15% market share within dental anesthetic sales, annual revenues could reach USD 150 million to USD 225 million, assuming stable market conditions.

Margins are typically high due to low raw material costs and established manufacturing processes. Profitability depends on manufacturing efficiency, regional sales distribution, and licensing agreements.

How do regional variations affect the product's financial outlook?

North America and Europe comprise over 70% of the market, with high margins supported by reimbursement and purchasing power. In Asia-Pacific, demand is rising at a higher CAGR (approximately 8%), driven by expanding dental care access.

Emerging markets, however, face challenges including regulatory hurdles and price sensitivity, which can suppress margins. Manufacturers often adopt tiered pricing or negotiate distribution deals tailored to regional economics.

What are future risks and opportunities?

Risks:

  • Emergence of new formulations offering enhanced duration or reduced toxicity.
  • Regulatory changes affecting approval or marketing practices.
  • Price competition from generics or private label products.

Opportunities:

  • Expansion into aesthetic and pain management markets.
  • Development of combination anesthetics with adjunctive agents.
  • Strategic partnerships to accelerate market penetration in emerging regions.

Closing Summary

CITANEST PLAIN DENTAL maintains a dominant position within dental local anesthetics due to its proven efficacy and safety. Market growth driven by increasing dental procedures worldwide, coupled with stable regulatory environments, supports its financial prospects. Despite competitive pressures, product stability and regional market variations shape a cautiously optimistic growth trajectory. Revenue estimates range from USD 150 million to USD 225 million annually, with high margins typical of this product class.


Key Takeaways

  • CITANEST PLAIN DENTAL is a core product in the global dental anesthesia market.
  • The market expands at around 6% CAGR, aligned with global dental care growth.
  • Revenue potential is estimated between USD 150 million and USD 225 million annually.
  • North America and Europe dominate the revenue landscape, with emerging markets offering growth opportunities.
  • Risks include regulatory changes and competitive innovations; opportunities involve product enhancements and regional expansion.

FAQs

1. Which regions offer the highest growth potential for CITANEST PLAIN DENTAL?
Asia-Pacific and Latin America show the highest growth rates, driven by increasing dental treatment access and economic development.

2. How does CITANEST compare to alternatives like articaine or prilocaine?
CITANEST has a proven safety profile and predictable onset and duration, making it a preferred choice, especially in established markets.

3. What regulatory hurdles does CITANEST face in emerging markets?
Regulatory approval timelines vary; some regions require local clinical data and product registration, potentially delaying market entry.

4. How might innovations in dental anesthesia impact CITANEST?
New formulations offering longer duration or reduced toxicity could challenge CITANEST’s market share unless it adopts similar advancements.

5. What strategic moves could enhance CITANEST’s market position?
Developing sustained-release formulations, entering new regional markets, and forming licensing partnerships could strengthen its foothold.


References

  1. Research and Markets. (2022). Dental Market - Global Forecast to 2028.
  2. U.S. Food and Drug Administration (FDA). (2022). Approved Drug Products.
  3. European Medicines Agency (EMA). (2022). Medicinal Product Database.

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