LIDEX Drug Patent Profile

When do Lidex patents expire, and when can generic versions of Lidex launch?

Lidex is a drug marketed by Alvogen and is included in three NDAs.

The generic ingredient in LIDEX is fluocinonide. There are nine drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the fluocinonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lidex

A generic version of LIDEX was approved as fluocinonide by TARO on June 10^th, 1987.

Summary for LIDEX

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	72
Patent Applications:	5,084
DailyMed Link:	LIDEX at DailyMed

US Patents and Regulatory Information for LIDEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alvogen	LIDEX	fluocinonide	CREAM;TOPICAL	016908-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Alvogen	LIDEX-E	fluocinonide	CREAM;TOPICAL	016908-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Alvogen	LIDEX	fluocinonide	OINTMENT;TOPICAL	016909-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Alvogen	LIDEX	fluocinonide	SOLUTION;TOPICAL	018849-001	Apr 6, 1984		DISCN	Yes	No

Expired US Patents for LIDEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	LIDEX	fluocinonide	CREAM;TOPICAL	016908-002	Approved Prior to Jan 1, 1982
Alvogen	LIDEX	fluocinonide	OINTMENT;TOPICAL	016909-002	Approved Prior to Jan 1, 1982
Alvogen	LIDEX	fluocinonide	CREAM;TOPICAL	016908-002	Approved Prior to Jan 1, 1982

International Patents for LIDEX

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

Country	Patent Number	Title	Estimated Expiration
Sweden	363975
Germany	1934334
Norway	129078
Netherlands	164199

LIDEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LIDEX

Introduction

LIDEX, a topical corticosteroid containing fluocinonide, is widely used for the treatment of various skin disorders, including eczema and other inflammatory skin conditions. To understand the market dynamics and financial trajectory of LIDEX, it is essential to delve into several key areas, including market trends, competitive landscape, regulatory environment, and financial performance.

Market Trends

Growing Demand for Topical Treatments

The global topical drug delivery market, which includes products like LIDEX, is experiencing significant growth. This market was valued at USD 109.16 billion in 2024 and is projected to reach USD 177.97 billion by 2031, growing at a CAGR of 6.3%[3].

Increasing Incidences of Skin Diseases

The rising incidence of skin diseases such as eczema, psoriasis, and atopic dermatitis is driving the demand for topical treatments. This trend is expected to continue, contributing to the growth of the market for products like LIDEX[3].

Preference for Non-Invasive Treatments

There is a growing preference for non-invasive treatment methods, which is another factor boosting the demand for topical drug delivery systems. Patients and healthcare providers are increasingly opting for topical treatments due to their ease of use and lower risk of systemic side effects[3].

Competitive Landscape

Key Players

The topical drug delivery market is highly competitive, with several major players including Hisamitsu Pharmaceuticals, Bayer AG, Novartis AG, Galderma Holding SA, and Johnson & Johnson Private Limited. These companies are continuously innovating and expanding their product portfolios, which includes products similar to LIDEX[3].

Market Position of LIDEX

LIDEX, with its potent glucocorticoid properties, holds a significant position in the market for treating inflammatory skin conditions. However, it faces competition from other topical corticosteroids and alternative drug delivery systems such as oral, injectable, and transdermal systems[1][4].

Regulatory Environment

Safety and Efficacy Regulations

The development and commercialization of topical drug delivery systems, including LIDEX, are heavily regulated. Stringent rules concerning the safety and efficacy of these products can sometimes delay their market entry and impact their growth potential. Regulatory compliance is crucial for maintaining market presence[3].

Post-Market Surveillance

Products like LIDEX are subject to post-market surveillance to monitor adverse reactions and ensure ongoing safety. This includes reporting of adverse reactions such as HPA axis suppression, Cushing’s syndrome, and other systemic effects associated with topical corticosteroid use[1].

Financial Performance

Pricing and Cost

The pricing of LIDEX varies depending on the formulation (cream, ointment, or gel) and the region. For example, the 0.05% cream formulation can range from $0.27 to $13.54 per tube, depending on the brand and size[4].

Market Valuation

While specific financial data for LIDEX alone is not readily available, the overall topical drug delivery market's valuation provides context. The market's growth from USD 109.16 billion in 2024 to USD 177.97 billion by 2031 indicates a robust financial trajectory for products in this category[3].

Technological Innovations

Formulation Advancements

LIDEX benefits from advanced formulations that enhance its efficacy and patient compliance. The cream, ointment, and gel formulations are designed to provide optimal release of the active ingredient, fluocinonide, while maintaining emollient and occlusive properties[1].

Drug Delivery Systems

Continuous innovations in drug delivery systems are driving the market forward. These advancements include the development of new vehicles that are greaseless, non-staining, and completely water miscible, which improves the overall patient experience[1].

Regional Analysis

Geographical Dominance

North America holds a significant position in the topical drug delivery market, driven by sophisticated healthcare infrastructure and substantial R&D investments. This region is likely to continue influencing the market dynamics for products like LIDEX[3].

Challenges and Opportunities

Competitive Pressure

The market faces competitive pressure from alternative drug delivery systems. However, the unique benefits of topical treatments, such as localized action and reduced systemic side effects, continue to make products like LIDEX attractive to both patients and healthcare providers[3].

Regulatory Obstacles

Regulatory hurdles can impede the growth of the market. However, companies that navigate these challenges effectively can capitalize on the growing demand for topical treatments and maintain a strong market position[3].

Key Takeaways

• The global topical drug delivery market is growing at a CAGR of 6.3%, driven by increasing skin disease incidence and a preference for non-invasive treatments.
• LIDEX, with its potent glucocorticoid properties, is a significant player in this market but faces competition from other topical corticosteroids and alternative drug delivery systems.
• Regulatory compliance is crucial, and continuous innovation in formulations and drug delivery systems is essential for maintaining market competitiveness.
• North America dominates the market due to its advanced healthcare infrastructure and R&D investments.

FAQs

What is LIDEX used for?

LIDEX is a topical corticosteroid used for the treatment of various inflammatory skin conditions, including eczema and psoriasis[1][4].

What are the potential side effects of LIDEX?

Potential side effects include HPA axis suppression, Cushing’s syndrome, skin atrophy, striae, and other systemic effects associated with topical corticosteroid use[1].

How does the market for topical drug delivery systems look in the future?

The market is projected to grow at a CAGR of 6.3% from 2024 to 2031, reaching USD 177.97 billion by the end of the forecast period[3].

What are the key drivers of the topical drug delivery market?

Key drivers include increasing incidences of skin diseases, a rising preference for self-administration, and technological advancements in drug formulations[3].

Which regions are dominant in the topical drug delivery market?

North America holds a preeminent position in the market due to its sophisticated healthcare infrastructure and substantial R&D investments[3].