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Last Updated: March 31, 2025

ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN Drug Patent Profile


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When do Arestocaine Hydrochloride W/ Levonordefrin patents expire, and what generic alternatives are available?

Arestocaine Hydrochloride W/ Levonordefrin is a drug marketed by Solvay and is included in one NDA.

The generic ingredient in ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN is levonordefrin; mepivacaine hydrochloride. There are two drug master file entries for this compound. Additional details are available on the levonordefrin; mepivacaine hydrochloride profile page.

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Summary for ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN at DailyMed
Drug patent expirations by year for ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN

US Patents and Regulatory Information for ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Solvay ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN levonordefrin; mepivacaine hydrochloride INJECTABLE;INJECTION 085010-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Articaine Hydrochloride with Levonordefrin: Market Dynamics and Financial Trajectory

Introduction

Articaine hydrochloride, often combined with the vasoconstrictor levonordefrin, is a widely used local anesthetic in dental procedures. This combination is renowned for its rapid onset, superior efficacy, and safety profile. Here, we delve into the market dynamics and financial trajectory of articaine hydrochloride with levonordefrin.

Market Size and Growth

The articaine hydrochloride market has been experiencing significant growth. As of 2023, the market size was valued at approximately USD 1221.99 million and is projected to grow to USD 2312.56 million by 2031, with a Compound Annual Growth Rate (CAGR) of 8.3% during the forecast period of 2024-2031[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the articaine hydrochloride market:

Effective Dental Treatments

Articaine hydrochloride is preferred by doctors due to its rapid action, superior efficacy, and ability to penetrate soft tissues and bone more effectively than other anesthetics like lidocaine. Its short elimination half-life, which is around 44 minutes, reduces the risk of systemic toxicity, making it ideal for patients with certain medical conditions[2].

Rising Dental Problems

The increasing incidence of dental problems, such as dental caries and periodontal diseases, particularly in regions with high consumption of junk food and growing elderly populations, is a significant driver. The development of dental anesthesia delivery systems, like computer-controlled local anesthetic delivery (CCLAD) systems, also supports market growth[1].

Growing Disposable Income and Cosmetic Dentistry

Increasing disposable income and the growing trend of cosmetic dentistry are additional factors contributing to the market's expansion. As people become more aware of the importance of dental health and aesthetics, the demand for articaine hydrochloride is expected to rise[1].

Regional Market Analysis

North America

North America holds the largest share of the articaine hydrochloride market, driven by growing awareness of corrective and preventive dental treatments in the U.S. and Canada. This region is expected to continue dominating the market during the forecast period[4].

Asia-Pacific

The Asia-Pacific region, particularly countries like China, Japan, and India, is experiencing rapid growth due to an increase in dental procedures and expanding healthcare systems. India, in particular, offers significant growth potential due to increasing awareness of modern dental anesthesia techniques[1][4].

Latin America, Middle East, and Africa

These regions are emerging as important growth areas due to rising dental procedures, expanding healthcare systems, and increasing disposable income. The growing knowledge of modern dental anesthesia techniques in these regions is also driving market expansion[1].

Competitive Landscape

The articaine hydrochloride market is highly competitive, with major pharmaceutical companies such as Septodont, Dentsply Sirona, Pierrel Pharma, 3M Company, and Anhui BBCA Pharmaceutical Co., Ltd. actively pursuing market share through product innovation, strategic partnerships, and geographical expansion. These companies are focusing on expanding their production capacity and introducing alternative products to address the dentistry sector[1][4].

Role of Levonordefrin

Levonordefrin, a topical sympathomimetic amine, is often combined with articaine hydrochloride to enhance the anesthetic effect by causing vasoconstriction. This combination helps in reducing bleeding at the surgical site and prolonging the duration of anesthesia. Levonordefrin acts as an alpha-1 adrenergic receptor inhibitor, which aids in nasal decongestion and vasoconstriction during dental procedures[5].

Challenges and Limitations

Despite the growth prospects, the market faces several challenges:

Regulatory Constraints

Unfavorable reimbursement regulations and the high cost of dental procedures are expected to hinder market expansion. Regulatory constraints, such as increased scrutiny of generic drug applications, can also raise the cost of obtaining approvals, potentially affecting market dynamics[1][3].

Availability of Substitute Products

The availability and use of substitute local anesthetics like lidocaine, prilocaine, mepivacaine, and bupivacaine could limit the growth of the articaine hydrochloride market. However, articaine's unique properties and advantages are likely to maintain its market position[1].

Financial Trajectory

The financial trajectory of articaine hydrochloride with levonordefrin is promising, driven by the growing demand for effective dental anesthetics. Here are some key financial highlights:

  • Market Size: The market was valued at USD 1128.33 million in 2022 and is projected to reach USD 2312.56 million by 2031[1].
  • CAGR: The market is expected to grow at a CAGR of 8.3% during the forecast period of 2024-2031[1].
  • Revenue Growth: The revenue is expected to increase significantly, driven by the expanding healthcare system, rising disposable income, and growing awareness of dental health[1][4].

Key Takeaways

  • The articaine hydrochloride market is driven by its superior efficacy, rapid action, and short elimination half-life.
  • North America and Asia-Pacific are key regions driving market growth.
  • The combination with levonordefrin enhances the anesthetic effect and is crucial in dental procedures.
  • Regulatory constraints and the availability of substitute products are potential challenges.
  • The market is expected to grow significantly, with a CAGR of 8.3% during the forecast period.

FAQs

What is the primary use of articaine hydrochloride with levonordefrin?

Articaine hydrochloride with levonordefrin is primarily used as a local anesthetic in dental procedures due to its rapid onset, superior efficacy, and ability to penetrate soft tissues and bone effectively.

Which regions are driving the growth of the articaine hydrochloride market?

North America and the Asia-Pacific region, particularly countries like China, Japan, and India, are driving the growth of the articaine hydrochloride market.

What are the key drivers of the articaine hydrochloride market?

The key drivers include the rising incidence of dental problems, growing disposable income, the trend of cosmetic dentistry, and the development of dental anesthesia delivery systems.

What challenges does the articaine hydrochloride market face?

The market faces challenges such as unfavorable reimbursement regulations, the high cost of dental procedures, and the availability of substitute local anesthetics.

How does levonordefrin enhance the anesthetic effect of articaine hydrochloride?

Levonordefrin enhances the anesthetic effect by causing vasoconstriction, which reduces bleeding at the surgical site and prolongs the duration of anesthesia.

What is the projected CAGR of the articaine hydrochloride market?

The articaine hydrochloride market is expected to grow at a CAGR of 8.3% during the forecast period of 2024-2031.

Sources

  1. SkyQuestT: Articaine Hydrochloride Market Size, Growth & Trends Report | 2032
  2. RDH Magazine: Selecting local anesthetic agents for nonsurgical periodontal therapy
  3. Federal Trade Commission: Generic Drug Industry Dynamics
  4. Transparency Market Research: Articaine Hydrochloride Market Size, Share | Industry Sales - 2034
  5. DrugBank: Levonordefrin: Uses, Interactions, Mechanism of Action

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