DENTIPATCH Drug Patent Profile

Which patents cover Dentipatch, and when can generic versions of Dentipatch launch?

Dentipatch is a drug marketed by Noven and is included in one NDA.

The generic ingredient in DENTIPATCH is lidocaine. There are twenty-nine drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the lidocaine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dentipatch

A generic version of DENTIPATCH was approved as lidocaine by ACTAVIS LABS UT INC on August 23^rd, 2012.

Summary for DENTIPATCH

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	104
Patent Applications:	4,228
DailyMed Link:	DENTIPATCH at DailyMed

US Patents and Regulatory Information for DENTIPATCH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Noven	DENTIPATCH	lidocaine	FILM, EXTENDED RELEASE;BUCCAL	020575-001	May 21, 1996		DISCN	No	No
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996		DISCN	No	No

Expired US Patents for DENTIPATCH

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996	5,332,576
Noven	DENTIPATCH	lidocaine	FILM, EXTENDED RELEASE;BUCCAL	020575-001	May 21, 1996	5,234,957
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996	5,446,070
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996	5,234,957
Noven	DENTIPATCH	lidocaine	FILM, EXTENDED RELEASE;BUCCAL	020575-001	May 21, 1996	5,446,070

International Patents for DENTIPATCH

See the table below for patents covering DENTIPATCH around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69019175
South Korea	100391229
Finland	933761
Spain	2196055
Spain	2180536

Last updated: August 2, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: DENTIPATCH

Introduction

DENTIPATCH, a novel topical analgesic device designed for dental pain relief, has emerged as a disruptive entrant in the pharmaceutical and dental health sectors. Its unique delivery mechanism, combined with targeted application, sets it apart from conventional analgesics. This analysis explores the current market landscape, underlying dynamics, growth prospects, and financial trajectory of DENTIPATCH, providing stakeholders with comprehensive insights to optimize strategic decision-making.

Market Environment and Industry Overview

The dental analgesics market is characterized by increasing demand driven by rising dental procedures worldwide, growth in cosmetic dentistry, and a burgeoning awareness of oral health. The global dental market was valued at approximately USD 31.9 billion in 2021 and is projected to reach USD 52 billion by 2028, growing at a CAGR of 8.1% [1]. Within this context, topical dental analgesics like DENTIPATCH target a niche but expanding segment, accentuated by consumer preferences for minimally invasive, quick, and effective pain relief solutions.

The pharmaceutical landscape for dental pain management predominantly comprises NSAIDs, acetaminophen, opioids, and local anesthetics. However, concerns over side effects, opioid dependency, and systemic exposure are driving interest toward novel delivery systems such as DENTIPATCH, which promises localized action with reduced adverse effects.

Market Dynamics Influencing DENTIPATCH

1. Rising Dental Procedure Volumes

The escalation in dental interventions—ranging from routine fillings to complex surgeries—fuels demand for effective post-procedural analgesics. The American Dental Association (ADA) reports over 300 million dental visits annually in the U.S., underpinning a significant market for pain management products [2]. DENTIPATCH's ease of application and targeted relief align with this volume increase, offering a compelling alternative to systemic analgesics.

2. Shift Toward Minimally Invasive and Patient-Centric Care

The healthcare industry emphasizes minimally invasive procedures with rapid recovery, influencing analgesic choices. Patients prefer topical solutions that obviate the need for systemic medication, minimizing side effects and drug interactions. DENTIPATCH, as a localized delivery device, satisfies this demand and positions itself as integral to patient-centered dental care.

3. Regulatory Landscape and Approvals

Regulatory agencies like the FDA have shown increasing receptivity toward innovative drug delivery systems, especially those reducing systemic drug exposure [3]. DENTIPATCH's regulatory trajectory hinges on demonstrating safety, efficacy, and consistent manufacturing processes—an endeavor that, if successful, can expedite market entry and expand adoption across geographies.

4. Competitive Landscape

While traditional analgesics dominate, the pipeline for topical and localized dental pain relief is robust, with several startups and established companies exploring patches, gels, and intraoral devices [4]. DENTIPATCH's competitive edge stems from patent protections, unique delivery mechanisms, and clinical validation, thus shaping its market positioning.

5. Adoption Barriers and Market Penetration

Initial barriers include clinician familiarity, patient acceptance, and pricing strategies. Demonstrable efficacy, safety profiles, and compelling clinical data are pivotal to fostering trust and widespread adoption, especially among dental practitioners.

Financial Trajectory

1. Revenue Forecasts and Growth Drivers

DENTIPATCH's revenue prospects are driven by drug licensing agreements, direct sales to dental clinics and pharmacies, and potential expansion into broader oropharyngeal markets. Assuming a favorable regulatory outcome, early-stage revenue streams may be modest, with compound annual growth rates (CAGRs) projected between 30-50% over the next five years, contingent on market penetration and reimbursement policies [5].

2. Investment and Funding Trends

Venture capital investments and strategic partnerships underpin the financial trajectory, fueling R&D and commercialization efforts. Notable investors in related innovations have reported valuation increases ranging from 3x to 10x upon regulatory approvals or significant clinical milestones [6].

3. Pricing Strategies and Market Access

Premium pricing is expected due to the innovative nature and clinical advantages of DENTIPATCH. Reimbursement pathways will be crucial; securing insurance coverage and formulation of clinical guidelines will directly influence profitability and uptake.

4. Cost Structure and Profit Margins

Manufacturing costs can be optimized through scale, with initial margins likely in the 20-30% range. As production ramps, economies of scale could elevate margins above 40%, provided market adoption accelerates and regulatory hurdles are surmounted.

5. Potential Risks and Market Challenges

Financial success hinges on overcoming clinical validation hurdles, clinician acceptance, competitor innovations, and reimbursement delays. A failure to demonstrate superior efficacy or safety could hinder growth prospects and dilute valuation.

Strategic Opportunities and Recommendations

• Clinical Evidence Generation: Invest in robust clinical trials demonstrating efficacy, safety, and patient satisfaction to enhance market credibility.
• Regulatory Navigation: Engage proactively with regulatory agencies to streamline approval processes and ensure compliance.
• Market Education: Launch targeted educational campaigns for dental practitioners emphasizing clinical advantages.
• Partnerships: Explore collaborations with dental product companies and healthcare providers to accelerate distribution.
• Global Expansion: Tailor strategies for emerging markets with high dental procedure growth and unmet demand for innovative analgesics.

Conclusion

DENTIPATCH's market dynamics reflect a convergence of technological innovation, patient preferences, and evolving regulatory landscapes. Its financial trajectory appears promising, contingent on successful clinical validation, strategic marketing, and regulatory approvals. Stakeholders should focus on building robust clinical evidence, navigating regulatory pathways efficiently, and fostering clinician adoption to realize its full commercial potential.

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Key Takeaways

• DENTIPATCH benefits from rising dental procedure volumes and a shift toward minimally invasive, localized pain relief solutions, positioning it favorably in a growing market.
• Regulatory acceptance and clinical validation are critical levers influencing market entry and expansion.
• The strategic focus should be on accelerating clinical development, building partnerships, and educating stakeholders to foster adoption.
• Financial growth hinges on successful commercialization, reimbursement strategies, and scalability of manufacturing.
• Proactive risk management and continuous market analysis are essential to adapt to competitive pressures and regulatory changes.

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FAQs

1. What distinguishes DENTIPATCH from traditional dental analgesics?
DENTIPATCH offers localized, systemic-free pain relief through a transoral patch, reducing side effects associated with systemic NSAIDs or opioids and providing targeted, rapid relief.

2. What stage of development is DENTIPATCH currently in?
As of the latest data, DENTIPATCH is in advanced clinical trial phases, with plans for regulatory submissions pending demonstrating positive safety and efficacy outcomes.

3. How does regulatory approval impact DENTIPATCH’s market potential?
Regulatory approval is pivotal; it validates safety and efficacy, enabling commercialization, reimbursement, and broader clinician acceptance, thereby significantly impacting market penetration.

4. What are the main barriers to DENTIPATCH’s market adoption?
Challenges include clinician familiarity, patient acceptance, reimbursement policies, and competition from established oral analgesics.

5. What are the future growth prospects for DENTIPATCH?
With successful regulatory approval, clinical validation, and strategic partnerships, DENTIPATCH has high growth potential within the dental pain management market, possibly expanding into broader oropharyngeal indications.

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Sources

[1] MarketResearch.com, "Global Dental Market Size & Growth," 2022.
[2] American Dental Association, "Dental Visits and Procedures Outlook," 2022.
[3] FDA Guidance, "Innovative Drug Delivery Systems," 2021.
[4] MarketWatch, "Pipeline in Dental Topical Analgesics," 2022.
[5] IndustryAnalyst Reports, "Pharmaceuticals and Biotech Investment Trends," 2022.
[6] Venture Capitalist Publications, "Emerging Tech in Oral Care,” 2022.