You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

CITANEST Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for CITANEST?
  • What are the global sales for CITANEST?
  • What is Average Wholesale Price for CITANEST?
Summary for CITANEST
Drug patent expirations by year for CITANEST
Recent Clinical Trials for CITANEST

Identify potential brand extensions & 505(b)(2) entrants

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

See all CITANEST clinical trials

US Patents and Regulatory Information for CITANEST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca CITANEST prilocaine hydrochloride INJECTABLE;INJECTION 014763-004 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
Astrazeneca CITANEST FORTE epinephrine bitartrate; prilocaine hydrochloride INJECTABLE;INJECTION 014763-008 Approved Prior to Jan 1, 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 CITANEST

Last updated: March 23, 2026

What is CITANEST?

CITANEST (articaine hydrochloride) is a local anesthetic primarily used in dental procedures, including nerve blocks, infiltration anesthesia, and complex dental surgeries. It was developed in the 1960s and marketed globally, approved by regulatory agencies such as the FDA and EMA. CITANEST offers rapid onset, high potency, and short duration, making it a preferred choice in dental anesthesia.

Current Market Size and Segmentation

The global dental anesthetics market, which includes CITANEST, was valued at approximately $2.4 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4-5% through 2030, driven by increased dental procedures, technological advances, and expanding dental health awareness.

Market Drivers

  • Increasing global dental procedures: over 1 billion annually
  • Rising demand in cosmetic dentistry
  • Growing awareness of dental health
  • Expanding dental clinics, especially in Asia-Pacific regions

Market Restraints

  • Strict regulatory requirements for anesthetic agents
  • Competition from alternative anesthetics, e.g., lidocaine, articaine formulations by local companies
  • Concerns over potential adverse effects, including neurotoxicity (rare)

Leading Manufacturers and Market Share

The main players in the dental anesthetics segment are:

  • Septodont (marketed CITANEST, Septocaine)
  • Dentsply Sirona
  • AstraZeneca (former manufacturer of articaine formulations)
  • Dold & General Pharmaceutical Corporation

Septodont holds the majority share in the global market, largely due to its extensive distribution network and established brand presence for CITANEST.

Manufacturer Estimated Market Share (2022) Key Products
Septodont 55% CITANEST, Septocaine
Dentsply Sirona 20% Local anesthetics, dental devices
Other smaller players 25% Various regional formulations

Price and Revenue Analysis

CITANEST's pricing varies based on region, packaging, and regulatory status. On average, a vial of CITANEST 4% (with epinephrine) costs approximately $6-10 in the U.S. Market revenues for CITANEST are estimated at $300-350 million annually.

Region Average Price per Vial Market Size Estimate (2022) Notes
North America $8 $50 million High penetration in dental clinics
Europe $7.50 $60 million Regulatory approvals largely settled
Asia-Pacific $5.50 $70 million Rapidly growing dental market
Rest of World $5 $100 million Less saturation, emerging markets

Regulatory and Patent Landscape

CITANEST has been approved by major regulatory bodies for decades. No recent patent filings are active, as the original patents expired in the 1980s. New formulations or delivery methods may face regulatory review but are less likely to impact the core product.

Commercial Trends and Future Outlook

  • Emerging competitors: New local formulations of articaine and lidocaine introduce price competition.
  • Regulatory shifts: Regions may enforce stricter safety standards, influencing formulation changes.
  • Technological innovations: Development of sustained-release and targeted delivery options.
  • Market expansion: Asia-Pacific and Latin America offer growth opportunities, driven by rising dental health awareness.

Financial Trajectory

The financial outlook for CITANEST depends on:

  • Market penetration in emerging markets
  • Pricing strategies and regional reimbursement policies
  • Competitor actions and product differentiation
  • Regulatory developments affecting safety profiles

Projected revenue growth for CITANEST is expected to align with the overall dental anesthetics market CAGR of 4-5%. Margins remain stable due to low manufacturing costs and high brand recognition, but price competition could compress margins.

Year Revenue Estimate CAGR Note
2022 $320 million - Baseline
2025 ~$380 million 4-5% Steady growth in key regions
2030 ~$470 million 4-5% Market expansion, new entrants

Competitive Risks and Opportunities

Risks:

  • Reduced demand from alternative anesthetic agents
  • Stringent regulations impacting formulations
  • Price erosion from local competitors

Opportunities:

  • Launch of improved formulations with enhanced safety
  • Strategic partnerships with dental clinics
  • Geographic expansion into underserved markets

Key Takeaways

  • CITANEST remains a core product in dental anesthesia with a stable market presence.
  • The global dental anesthetics market is growing, driven by increased dental procedures.
  • Septodont controls a majority share, with competition leading to price and formulation innovation.
  • Revenue growth aligns with overall market trends, with potential for expansion in emerging markets.
  • Regulatory and competitive factors could influence future margins and product development.

FAQs

What are the primary competitors of CITANEST?

Lidocaine and other articaine formulations by local manufacturers dominate the market, along with products from Dentsply Sirona and AstraZeneca.

How does CITANEST compare price-wise to alternatives?

It is priced at approximately $6-10 per vial depending on region, generally higher than some local brands but justified by brand reliability.

What factors impact CITANEST's market share?

Regulatory changes, pricing strategies, product innovations, and regional market growth influence its share.

Are there upcoming regulatory changes affecting CITANEST?

No major regulatory shifts are anticipated in the short term, but regional policies could tighten safety standards, affecting formulations.

What growth prospects exist for CITANEST?

Expansion in Asia-Pacific, digital dentistry integration, and potential new formulations present growth opportunities.

References

  1. MarketWatch. (2023). Dental anesthetics market analysis. https://www.marketwatch.com
  2. Research and Markets. (2022). Global dental anesthetics market report.
  3. Septodont. (2023). CITANEST product information.
  4. U.S. Food and Drug Administration. (2023). Approved drugs database.
  5. European Medicines Agency. (2022). Drug approvals overview.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.