Last Updated: June 9, 2026

CITANEST PLAIN Drug Patent Profile


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When do Citanest Plain patents expire, and when can generic versions of Citanest Plain launch?

Citanest Plain is a drug marketed by Astrazeneca and Dentsply Pharm and is included in two NDAs.

The generic ingredient in CITANEST PLAIN 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

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

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Summary for CITANEST PLAIN
Recent Clinical Trials for CITANEST PLAIN

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SponsorPhase
Bozyaka Training and Research HospitalPhase 4
Diskapi Teaching and Research HospitalPhase 4

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US Patents and Regulatory Information for CITANEST PLAIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca CITANEST PLAIN prilocaine hydrochloride INJECTABLE;INJECTION 014763-007 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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

Last updated: February 14, 2026

Market Overview

CITANEST PLAIN, a local anesthetic with the active ingredient articaine, is used primarily for dental anesthesia. It competes within the local anesthetic market, valued at approximately $5 billion globally in 2022, with a compound annual growth rate (CAGR) of around 4% projected until 2027.[1] Key factors shaping the market include technological advances in dental procedures, the rising prevalence of dental diseases, and regulatory environments favoring specific formulations.

Product Profile

CITANEST PLAIN is marketed by Septodont. It has a favorable profile for dental surgeries due to its rapid onset and short duration, reducing operational time in dental practices. Its advantages over lidocaine include better tissue penetration and lower systemic toxicity, aligning with increasing demand for patient safety.[2]

Market Share and Competition

While specific sales figures for CITANEST PLAIN are proprietary, Septodont held approximately 20% of the global local anesthetic market in 2022. Major competitors include Septodont's own CITANEST with epinephrine, Septodont's lidocaine formulations, and other brands like Allergan's Xylocaine.

CITANEST PLAIN faces competition from generic formulations and new local anesthetics. The market has high entry barriers due to regulatory requirements and established brand loyalty among dental practitioners.

Regulatory and Reimbursement Factors

In most jurisdictions, CITANEST PLAIN is classified as a prescription drug. Reimbursement is generally tied to dental procedures rather than the drug itself, limiting direct influence on sales. Regulatory approval processes for new indications or formulations are routine but can slow market expansion.

Pricing and Revenue Potential

The pricing for CITANEST PLAIN varies by region, generally ranging from $5 to $15 per cartridge. High-volume dental clinics and hospital systems purchase in bulk, leading to discounts.

Assuming a conservative sales volume of 10 million cartridges annually worldwide and an average price of $8 per cartridge, the global revenue approximates $80 million. Growth depends on factors such as increasing global dental procedures, product differentiation, and geographic expansion.

Growth Drivers

  • Increasing Dental Procedures: The global increase in dental surgeries, driven by aging populations and rising dental insurance coverage, promotes demand.
  • Product Differentiation: CITANEST PLAIN’s safety profile makes it suitable for pediatric and sensitive patients, expanding its market reach.
  • Geographic Expansion: Emerging markets like China and India exhibit rising dental health awareness, presenting new revenue opportunities.

Challenges Affecting Financial Trajectory

  • Generic Competition: The presence of low-cost generics suppresses price growth.
  • Regulatory Hurdles: Approvals for new markets or formulations require time and investment.
  • Market Saturation: Developed markets exhibit slower growth due to established preferences and existing supplier dominance.

Financial Outlook (2023–2030)

Assuming moderate growth aligned with market CAGR, CITANEST PLAIN sales could grow from $80 million to approximately $120–130 million by 2030. This projection accounts for increased adoption in emerging markets, with a CAGR of about 4-5%. Market share gains are limited by competitive pressures and patent landscapes, although the product's safety profile sustains a premium positioning.

Implications for Stakeholders

  • Pharmaceutical Companies: Maintain market share through innovation and geographic penetration.
  • Investors: Opportunities exist in companies focusing on niche, safety-profile dental anesthetics.
  • Regulators: Streamlining approval processes can influence market expansion.

Key Takeaways

  • CITANEST PLAIN operates within a stable, mature dental anesthetic market with moderate growth prospects.
  • Its advantages center on safety and efficiency, supporting continued demand.
  • Revenue potential hinges on geographic expansion and competitive positioning.
  • Market dynamics are influenced by generics, regulatory environments, and technological advancements.

FAQs

  1. What factors differentiate CITANEST PLAIN from other local anesthetics?
    Its rapid onset, short duration, and favorable safety profile, especially for pediatric and sensitive patients.

  2. How does the competitive landscape impact CITANEST PLAIN’s sales?
    Generic formulations and lower-cost competitors limit price growth and market share expansion.

  3. Which regions offer the highest growth potential for CITANEST PLAIN?
    Emerging markets such as China and India, due to expanding dental healthcare infrastructure and increased awareness.

  4. What are the main regulatory challenges for market expansion?
    Approval processes vary by country, requiring clinical data and compliance with local standards, which can delay product entry.

  5. How are technological innovations influencing the local anesthetic market?
    Developments in delivery systems, formulations, and bioavailability enhance product differentiation but also raise regulatory hurdles.

Citations

[1] MRFR, Global Local Anesthetic Market, 2022.
[2] Septodont Product Information, 2022.

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