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Last Updated: December 22, 2024

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE Drug Patent Profile


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When do Articaine Hydrochloride And Epinephrine Bitartrate patents expire, and what generic alternatives are available?

Articaine Hydrochloride And Epinephrine Bitartrate is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE is articaine hydrochloride; epinephrine bitartrate. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the articaine hydrochloride; epinephrine bitartrate profile page.

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Summary for ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE at DailyMed
Drug patent expirations by year for ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

US Patents and Regulatory Information for ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE articaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 079138-001 Jun 18, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE Market Analysis and Financial Projection Experimental

Articaine Hydrochloride and Epinephrine Bitartrate: Market Dynamics and Financial Trajectory

Market Overview

Articaine hydrochloride, often combined with epinephrine bitartrate, is a local anesthetic widely used in dental procedures due to its rapid action and superior efficacy. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global articaine hydrochloride market is experiencing significant growth. As of 2022, the market size was valued at USD 1.128 billion and is projected to grow to USD 2.135 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 8.3% during the forecast period (2024-2031)[3].

Another estimate suggests that the market will grow from USD 1.75 billion in 2024 to USD 3.27 billion by 2032, exhibiting a CAGR of around 7-8%[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].

Europe

Europe is another significant market, with a steady growth anticipated due to rising dental treatment needs and increasing awareness of preventative and remedial treatments. The region focuses on efficient office management systems to enhance clinical treatment[3].

Asia-Pacific

The Asia-Pacific region is witnessing rapid growth, particularly in countries like China, Japan, and India, where dental procedures are increasing. This region is expected to continue its exponential expansion[3].

Latin America, Middle East, and Africa

These regions are emerging as important growth areas due to the rise in dental procedures, expansion of the healthcare system, increased disposable income, and growing awareness of modern dental anesthesia techniques[3].

Market Drivers

Effective Dental Treatments

Articaine hydrochloride is preferred over other anesthetics like lidocaine due to its superior efficacy, especially in patients with hypokalemic sensory overstimulation. Its ability to penetrate soft tissues and bone effectively contributes to its popularity[3].

Rising Dental Problems

The increasing incidence of dental problems, such as dental caries and periodontal diseases, driven by factors like junk food consumption and an aging population, is driving the demand for articaine hydrochloride[3].

Cosmetic Dentistry and Disposable Income

Growing trends in cosmetic dentistry and increasing disposable income are supporting market expansion. The use of computer-controlled local anesthetic delivery (CCLAD) systems has also enhanced patient tolerance and efficacy[3].

Research and Development

Ongoing research and development in dental anesthesia delivery systems and the innovative nature of the dental anesthetics industry are expected to propel market growth. New formulations, such as articaine-loaded poly(ε-caprolactone) nanocapsules, are being explored to reduce toxicity and increase analgesic efficacy[5].

Market Restraints

Unfavorable Reimbursement Regulations

Unfavorable reimbursement regulations and the high cost of dental procedures are expected to impede market expansion. These factors can limit access to articaine hydrochloride, especially in regions with limited healthcare resources[3].

Availability of Substitute Products

The availability of substitute local anesthetics like lidocaine, prilocaine, mepivacaine, and bupivacaine may also hinder the market growth for articaine hydrochloride. Key players are expanding their production capacity by introducing alternative products, which could raise competition[3][4].

End-User Analysis

Dental Clinics

Dental clinics are the largest segment of the articaine hydrochloride market. The growing need for dental treatments and the preference for articaine hydrochloride in these settings drive this segment[3].

Hospitals

Hospitals are also significant end-users, with a growing acceptance of articaine hydrochloride among dental practitioners. This segment is expected to see substantial growth during the forecast period[3].

Ambulatory Surgical Centers

Ambulatory surgical centers are another growing segment, as they increasingly adopt advanced dental anesthesia techniques[4].

Competitive Landscape

Major international pharmaceutical companies such as Septodont, Dentsply Sirona, Pierrel Pharma, 3M Company, and Anhui BBCA Pharmaceutical Co., Ltd. are actively competing in the market. These companies are focusing on product innovation, strategic partnerships, and geographical expansion to meet the growing global demand[3].

Safety and Adverse Reactions

While articaine hydrochloride is generally safe, it can cause significant adverse reactions. These include restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression, or drowsiness as early warning signs of central nervous system toxicity. Persistent paresthesias and hypoesthesia, especially in pediatric patients, have also been reported. Ischemic injury and necrosis due to vascular spasm are other potential risks[2].

Key Takeaways

  • Market Growth: The articaine hydrochloride market is projected to grow significantly, driven by its superior efficacy and increasing dental treatment needs.
  • Regional Dominance: North America and Europe are leading markets, with Asia-Pacific showing rapid growth.
  • Market Drivers: Effective dental treatments, rising dental problems, and growing trends in cosmetic dentistry are key drivers.
  • Market Restraints: Unfavorable reimbursement regulations and the availability of substitute products are potential restraints.
  • End-User Analysis: Dental clinics and hospitals are the primary end-users, with ambulatory surgical centers growing in importance.
  • Competitive Landscape: Major pharmaceutical companies are competing through innovation and strategic partnerships.

FAQs

What is the projected market size of articaine hydrochloride by 2031?

The global articaine hydrochloride market is projected to grow to USD 2.135 billion by 2031[3].

Which regions are leading the articaine hydrochloride market?

North America and Europe are currently the leading regions, with Asia-Pacific showing rapid growth[3][4].

What are the main drivers of the articaine hydrochloride market?

The main drivers include its superior efficacy, rising dental problems, growing trends in cosmetic dentistry, and advancements in pharmaceutical delivery technology[3].

What are the potential restraints to the market growth of articaine hydrochloride?

Unfavorable reimbursement regulations and the availability of substitute local anesthetics are potential restraints[3].

Which end-users are the largest consumers of articaine hydrochloride?

Dental clinics are the largest segment, followed by hospitals and ambulatory surgical centers[3].

What are the common adverse reactions associated with articaine hydrochloride?

Common adverse reactions include restlessness, anxiety, tinnitus, dizziness, and persistent paresthesias, among others[2].

Sources

  1. Market Research Future: Articaine Hydrochloride Market Size, Growth and Forecast – 2032[1]
  2. DailyMed: Articaine Hydrochloride and Epinephrine Bitartrate Injection[2]
  3. SkyQuest: Articaine Hydrochloride Market Size, Growth & Trends Report | 2031[3]
  4. Transparency Market Research: Articaine Hydrochloride Market Size, Share | Industry Sales - 2034[4]
  5. PLOS ONE: Promising potential of articaine-loaded poly(epsilon-caprolactone) nanocapsules for local or topical anesthesia in dentistry[5]

More… ↓

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