LIDOSITE TOPICAL SYSTEM KIT Drug Patent Profile

Which patents cover Lidosite Topical System Kit, and what generic alternatives are available?

Lidosite Topical System Kit is a drug marketed by Vyteris and is included in one NDA.

The generic ingredient in LIDOSITE TOPICAL SYSTEM KIT 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.

Summary for LIDOSITE TOPICAL SYSTEM KIT

US Patents:	0
Applicants:	1
NDAs:	1
DailyMed Link:	LIDOSITE TOPICAL SYSTEM KIT at DailyMed

US Patents and Regulatory Information for LIDOSITE TOPICAL SYSTEM KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004		DISCN	No	No

Expired US Patents for LIDOSITE TOPICAL SYSTEM KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004	6,629,968
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004	5,246,418
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004	6,862,473
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004	6,635,045
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004	6,385,488
Vyteris	LIDOSITE TOPICAL SYSTEM KIT	epinephrine; lidocaine hydrochloride	PATCH;IONTOPHORESIS, TOPICAL	021504-001	May 6, 2004	6,377,847

International Patents for LIDOSITE TOPICAL SYSTEM KIT

See the table below for patents covering LIDOSITE TOPICAL SYSTEM KIT around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1207936
Canada	2364414
France	2793695	CIRCUITS POUR AUGMENTER LA FIABILITE D'UN SYSTEME D'IONOPHORESE
Australia	7845494
World Intellectual Property Organization (WIPO)	0074772
Germany	69225387

LIDOSITE TOPICAL SYSTEM KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Topical Anesthesia: A Focus on Lidocaine-Based Products like ZTlido®

Introduction to Topical Anesthesia

Topical anesthesia, including products like the Lidocaine Topical System Kit, has become a pivotal segment in the pharmaceutical industry. These products are designed to provide localized pain relief, making them essential in various medical and cosmetic procedures.

Market Size and Growth

The topical drug delivery market, which includes topical anesthesia products, is projected to grow significantly. By 2031, this market is expected to reach USD 229.91 billion, growing at a compound annual growth rate (CAGR) of 9.1% from 2024 to 2031[3].

Key Drivers of the Market

Increasing Prevalence of Chronic Conditions

The rising prevalence of chronic conditions such as arthritis and neuropathic pain is a major driver for the topical anesthesia market. Patients are increasingly turning to topical solutions due to their ease of application and reduced side effects compared to oral medications[1].

Regulatory Shifts and Patient Safety

Regulatory authorities are emphasizing patient safety, advocating for the controlled use of topical anesthetics. This has led to the adoption of over-the-counter products for non-prescription use and stricter regulations for stronger formulations, driving innovation in the market[1].

Growing Demand for Pain Relief

The increasing demand for pain relief drugs, particularly non-opioid alternatives, is another significant factor. This demand is fueled by the global rise in chronic and acute pain-related disorders[4].

Regional Market Dynamics

Americas: The Largest Market

The Americas, particularly the United States, dominate the topical anesthesia market due to robust healthcare infrastructure, a large patient population, and the strong presence of key market players. The increasing adoption of topical anesthesia in outpatient settings, such as ambulatory surgical centers and dermatology clinics, has further fueled market growth[1].

Asia Pacific: The Fastest Growing Region

The Asia Pacific region is the fastest growing market, driven by population growth, rising healthcare spending, and increasing demand for surgical and cosmetic procedures. Countries like China, India, Japan, and South Korea are key contributors to this growth[1].

Financial Trajectory of Lidocaine-Based Products

ZTlido®: A Case Study

ZTlido®, a prescription lidocaine topical system developed by Scilex Holding Company, is a prime example of a successful lidocaine-based product. For the first quarter of 2024, ZTlido® gross sales ranged from $34.0 million to $38.0 million, representing a growth of 24% to 38% compared to the same period in 2023. Net sales for the same period were between $12.0 million and $13.0 million, showing a growth of 13% to 23%[2].

Preliminary Financial Results for 2024

In July 2024, Scilex reported preliminary net sales for ZTlido® to be between $4.0 million and $5.0 million, a significant increase from the $2.7 million recorded in the same month the previous year. This represents a growth of approximately 48% to 85%[5].

Competitive Positioning and Market Share

Companies like Scilex Holding are positioning themselves strongly in the market through innovative products and strategic commercial ramps. The competitive landscape is characterized by market share analysis, service positioning, and a market position matrix, indicating a highly competitive and innovation-driven environment[1].

Challenges and Opportunities

Product Stability and Penetration

One of the challenges in the topical drug delivery market is ensuring product stability and preventing degradation during storage. Formulating drugs that can effectively penetrate the skin to reach the target site is another significant challenge[3].

Advancements in Material Sciences

Advancements in material sciences and transdermal drug delivery technologies offer opportunities for developing more effective topical dosage forms. These advancements allow for the formulation of drugs that can selectively target deeper skin layers and tissues, enhancing treatment efficiency[3].

Illustrative Statistics

• The global lidocaine market is expected to reach USD 1,137.31 million by 2030, growing at a CAGR of 5.8%[4].
• The topical drug delivery market is estimated to grow from USD 124.90 billion in 2024 to USD 229.91 billion by 2031, at a CAGR of 9.1%[3].

Quotes from Industry Experts

"We believe the non-opioid pain management prescription market is adopting our products rapidly and should be reflected in continued sales growth, both within the traditional neuropathic pain and migraine non-opioid market and from the additional potential launch of our new gout prophylaxis product, Gloperba®"[2].

Key Takeaways

• The topical anesthesia market is driven by the increasing prevalence of chronic conditions and regulatory shifts emphasizing patient safety.
• Lidocaine-based products like ZTlido® are experiencing significant growth, driven by their efficacy and the growing demand for non-opioid pain management solutions.
• The Asia Pacific region is the fastest growing market, while the Americas remain the largest.
• Advancements in material sciences and transdermal drug delivery technologies are key opportunities for market growth.

FAQs

What is the projected growth rate of the topical drug delivery market?

The topical drug delivery market is expected to grow at a CAGR of 9.1% from 2024 to 2031[3].

Which region is the largest market for topical anesthesia?

The Americas, particularly the United States, represent the largest market for topical anesthesia[1].

What are the key challenges in the topical drug delivery market?

Ensuring product stability, preventing degradation during storage, and formulating drugs that can effectively penetrate the skin are significant challenges[3].

How is Scilex Holding Company performing in the market?

Scilex Holding Company is experiencing significant growth with its product ZTlido®, with preliminary net sales for July 2024 estimated to be between $4.0 million and $5.0 million, representing a growth of approximately 48% to 85%[5].

What are the future prospects for lidocaine-based products?

Lidocaine-based products are expected to continue growing due to their efficacy and the increasing demand for non-opioid pain management solutions. Advancements in material sciences and transdermal drug delivery technologies will further enhance their market position[3][4].

Cited Sources:

1. GlobeNewswire: Topical Anesthesia Market Research 2024 - GlobeNewswire
2. Scilex Holding Company: Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results For Gross and Net Sales for ZTlido®
3. Coherent Market Insights: Topical Drug Delivery Market Size & Share Analysis - Growth Trends
4. Biospace: Lidocaine Market Size 2022-2030 - Increasing Prevalence Of Various Chronic Diseases
5. Synapse: Scilex Holding Releases Preliminary Financial Results for July 2024