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

Last Updated: March 31, 2025

XYLOCAINE DENTAL Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Xylocaine Dental patents expire, and what generic alternatives are available?

Xylocaine Dental is a drug marketed by Dentsply Pharm and is included in two NDAs.

The generic ingredient in XYLOCAINE DENTAL is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

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

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

SponsorPhase
Tribhuvan University, NepalPhase 3
National Medical College, Birgunj, NepalPhase 3
Alfarabi CollegesN/A

See all XYLOCAINE DENTAL clinical trials

US Patents and Regulatory Information for XYLOCAINE DENTAL

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Dentsply Pharm XYLOCAINE DENTAL lidocaine hydrochloride INJECTABLE;INJECTION 021380-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Dentsply Pharm XYLOCAINE DENTAL WITH EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 021381-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Dentsply Pharm XYLOCAINE DENTAL WITH EPINEPHRINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 021381-002 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 3 of 3 entries

Market Dynamics and Financial Trajectory for Xylocaine Dental

Market Overview

The dental anesthetics market, within which Xylocaine Dental operates, is experiencing significant growth driven by several key factors.

Market Size and Growth Projections

The global dental anesthetics market is projected to reach USD 1.64 billion by 2024 and is expected to grow at a CAGR of 5.35% to reach USD 2.12 billion by 2029[1].

Regional Market Performance

North America currently holds the largest market share, while the Asia-Pacific region is anticipated to be the fastest-growing market over the forecast period. This growth is fueled by increasing dental tourism, a burgeoning population, and improvements in healthcare infrastructure[1][3].

Product Overview: Xylocaine Dental

Xylocaine Dental, also known as lidocaine, is a local anesthetic used to prevent or relieve pain during dental procedures. It contains lidocaine hydrochloride and adrenaline (epinephrine) to prolong the anesthetic effect and reduce bleeding at the injection site[2][5].

Usage and Benefits

Xylocaine Dental is injected into the mouth to block nerve signals to the brain, providing either total or partial loss of feeling. The inclusion of adrenaline helps in reducing blood flow to the area, making it easier for dentists to perform procedures[2].

Technological Advancements and Innovation

The dental anesthetics market, including Xylocaine Dental, is benefiting from technological advancements.

Computer-Controlled Delivery Systems

Computer-controlled local anesthetic delivery systems are gaining traction due to their ability to minimize pain by controlling the flow rate of the anesthetic solution. This technology enhances the user experience and reduces discomfort, which can increase the adoption of products like Xylocaine Dental[3].

New Formulations and Delivery Methods

There is a surge in the development of new formulations and delivery methods. For instance, articaine is becoming popular due to its enhanced potency and reduced risk of toxicity, although lidocaine remains a gold standard in dentistry[3][4].

Regulatory Landscape

The regulatory environment plays a crucial role in shaping the market dynamics for Xylocaine Dental.

Compliance with Regulatory Standards

Stricter regulations are leading to the adoption of safer, more effective anesthetic agents. The approval of newer anesthetics like articaine reflects a shift towards more efficacious and safer options, which can influence the market share of Xylocaine Dental[3].

Consumer Awareness and Preferences

Patients are becoming more knowledgeable about dental procedures and are seeking options that offer minimal discomfort.

Preference for Local Anesthesia

Local anesthesia, including products like Xylocaine Dental, is preferred over general anesthesia due to its rare and usually minor side effects. This preference is expected to drive the demand for local anesthetics, particularly in smaller, less invasive dental surgeries[1][4].

Economic Indicators

The economic prosperity of a region significantly influences its dental anesthesia market.

Rising Disposable Incomes

In emerging economies, rising disposable incomes have led to increased spending on elective dental procedures, subsequently boosting the demand for dental anesthesia. This trend is expected to continue, supporting the growth of the market for Xylocaine Dental[3].

Competitive Arena

The market for dental anesthetics is moderately consolidated with a few key players.

Major Players

Companies like Dentsply Sirona, Septodont, Hikma Pharmaceuticals PLC, Pierrel S.P.A., and Henry Schein Inc. are major players in the dental anesthetics market. Mergers and acquisitions, such as Septodont's acquisition of DLA's dental anesthesia business, are common strategies to expand product portfolios and geographic reach[1][3].

Financial Trajectory

The financial performance of Xylocaine Dental is closely tied to the overall dental anesthetics market.

Market Size and Growth

Given that the global dental anesthetics market is expected to grow from USD 1.64 billion in 2024 to USD 2.12 billion by 2029, products like Xylocaine Dental are likely to see increased demand and revenue growth[1].

Segmental Growth

The local anesthesia segment, which includes Xylocaine Dental, is expected to witness significant growth due to its advantages over general anesthesia, such as lower costs and fewer complications. The increasing prevalence of dental caries and dental trauma, along with technological advancements, will further drive this segment's growth[1].

Challenges and Restraints

While the market for Xylocaine Dental is growing, there are some challenges to consider.

Side Effects and Complications

Patient discomfort, risks, and complications associated with dental anesthetics can restrain market growth. However, these side effects are generally rare and mild, with serious side effects being very rare[2][5].

Key Takeaways

  • The global dental anesthetics market, including Xylocaine Dental, is projected to grow significantly, driven by technological advancements and increasing demand for dental care.
  • Local anesthesia, particularly lidocaine-based products like Xylocaine Dental, is preferred due to its safety and effectiveness.
  • The Asia-Pacific region is expected to be the fastest-growing market, while North America holds the largest market share.
  • Regulatory compliance and consumer preferences for minimal discomfort are key drivers of market growth.
  • Despite some challenges related to side effects, the overall financial trajectory for Xylocaine Dental is positive.

FAQs

1. What is the expected growth rate of the dental anesthetics market? The dental anesthetics market is expected to grow at a CAGR of 5.35% from 2024 to 2029[1].

2. Which region is the largest market for dental anesthetics? North America currently holds the largest market share in the dental anesthetics market[1].

3. What are the key benefits of Xylocaine Dental? Xylocaine Dental provides effective local anesthesia with minimal side effects and includes adrenaline to reduce bleeding and prolong the anesthetic effect[2].

4. How does technological integration impact the market for Xylocaine Dental? Technological advancements, such as computer-controlled delivery systems, enhance the user experience and reduce discomfort, increasing the adoption of products like Xylocaine Dental[3].

5. What are the common side effects of Xylocaine Dental? Common side effects include nervousness, dizziness, blurred vision, and nausea, while serious side effects are rare and include allergic reactions and severe complications[2][5].

Cited Sources

  1. Mordor Intelligence: Dental Anesthetics Market Size & Share Analysis.
  2. NPS MedicineWise: 2% Xylocaine Dental with adrenaline (epinephrine) 1:80000.
  3. Faster Capital: Dental anesthesia market: Market Trends and Opportunities in Dental Anesthesia.
  4. Precedence Research: U.S. Dental Anesthesia Market Size to Hit USD 492.36 Bn by 2033.
  5. FDA: 2% Xylocaine DENTAL with epinephrine 1:50,000.

More… ↓

⤷  Try for Free

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. 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.