NAFTIFINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for naftifine hydrochloride and what is the scope of freedom to operate?

Naftifine hydrochloride is the generic ingredient in two branded drugs marketed by Amneal, Taro, Xiromed, and Sebela Ireland Ltd, and is included in nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naftifine hydrochloride has three patent family members in three countries.

There are seven drug master file entries for naftifine hydrochloride. Three suppliers are listed for this compound.

Summary for NAFTIFINE HYDROCHLORIDE

International Patents:	3
US Patents:	6
Tradenames:	2
Applicants:	4
NDAs:	9
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	9
Patent Applications:	908
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAFTIFINE HYDROCHLORIDE
What excipients (inactive ingredients) are in NAFTIFINE HYDROCHLORIDE?	NAFTIFINE HYDROCHLORIDE excipients list
DailyMed Link:	NAFTIFINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NAFTIFINE HYDROCHLORIDE

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

Sponsor	Phase
GenZum Life Sciences LLC	Phase 3
Semler Research Center Pvt. Ltd.	Phase 3
Genzum Life Sciences	Phase 3

See all NAFTIFINE HYDROCHLORIDE clinical trials

Pharmacology for NAFTIFINE HYDROCHLORIDE

Drug Class

Allylamine Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for NAFTIFINE HYDROCHLORIDE

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for NAFTIFINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAFTIN	Gel	naftifine hydrochloride	2%	204286	1	2015-02-04

US Patents and Regulatory Information for NAFTIFINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes			Y
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes			Y
Xiromed	NAFTIFINE HYDROCHLORIDE	naftifine hydrochloride	CREAM;TOPICAL	210038-001	Sep 22, 2020	AB	RX	No	No
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	204286-001	Jun 27, 2013	AB	RX	Yes	Yes			Y
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	CREAM;TOPICAL	019599-001	Feb 29, 1988		DISCN	Yes	No

Expired US Patents for NAFTIFINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	CREAM;TOPICAL	019599-001	Feb 29, 1988
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990
Sebela Ireland Ltd	NAFTIN	naftifine hydrochloride	GEL;TOPICAL	019356-001	Jun 18, 1990

International Patents for NAFTIFINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Australia	2014212201	Topical compositions and methods for making and using same
Australia	2014212201
World Intellectual Property Organization (WIPO)	2014121048
Canada	2899725
Canada	2899725	COMPOSITIONS TOPIQUES ET PROCEDES DE PREPARATION ET D'UTILISATION CORRESPONDANTS (TOPICAL COMPOSITIONS AND METHODS FOR MAKING AND USING SAME)

NAFTIFINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naftifine Hydrochloride

Introduction

Naftifine hydrochloride, a synthetic allylamine antifungal, has been a significant player in the treatment of various fungal infections, including athlete's foot, jock itch, and ringworm. This article delves into the market dynamics and financial trajectory of naftifine hydrochloride, highlighting key factors driving its growth and challenges it faces.

Market Size and Growth Projections

The naftifine hydrochloride API market has witnessed substantial growth in recent years and is anticipated to continue this trend. By 2023, the market had reached a value of several billion USD and is projected to attain even higher values by 2031, driven by robust growth rates[1].

Segmentation of the Market

The naftifine hydrochloride market is segmented based on type (0.99, 0.995, and others) and application (ointments, gels, and others). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. This segmentation helps in understanding the diverse market dynamics and opportunities across different regions and product types[1].

Drivers of Market Growth

Several factors are driving the growth of the naftifine hydrochloride market:

Increasing Prevalence of Skin Diseases

The rising incidence of skin conditions such as acne, rosacea, and eczema is a significant driver. As more people suffer from these conditions, the demand for effective treatments like naftifine hydrochloride increases[4].

Growing Awareness About Skin Care

There is a growing awareness among consumers about the importance of skin health, leading to an increased demand for skincare products, including antifungal ointments and gels containing naftifine hydrochloride[4].

Demand for Versatile Products

Naftifine hydrochloride ointments are versatile and can be used on both children and adults with various skin types and conditions, which adds to their popularity and market demand[4].

Application and Usage

Naftifine hydrochloride is primarily used in the form of ointments and gels for treating fungal infections.

Ointments and Gels

These formulations are widely used in retail and hospital pharmacies. The product's effectiveness in reducing acne breakouts by up to 50% further enhances its market appeal[4].

Distribution Channels

The majority of naftifine hydrochloride products are distributed through U.S. outpatient retail pharmacies, with a smaller percentage going to non-retail settings and mail-order/specialty pharmacies[2].

Safety and Regulatory Overview

FDA Approval and Safety Review

Naftifine hydrochloride gel was approved by the FDA in 2013, and subsequent safety reviews have not identified any significant safety concerns. The product has a well-established safety profile, with no pediatric safety signals or reported deaths associated with its use[2][5].

Financial Performance and Projections

The financial trajectory of the naftifine hydrochloride market is promising, with significant growth anticipated over the next several years.

Revenue Projections

The market is expected to grow substantially from 2023 to 2031, driven by increasing demand and favorable market dynamics. The exact revenue figures are projected to be in the billions of USD by the end of the forecast period[1].

CAGR and Market Value

The global athlete's foot drugs market, which includes naftifine hydrochloride, is expected to grow at a CAGR of 7.8% from 2024 to 2030, reaching a market value of US$ 2.1 billion by 2030. This growth rate is indicative of the broader antifungal market's potential[3].

Regional Analysis

The market for naftifine hydrochloride is geographically diverse, with key regions including:

North America

This region is a significant market due to high consumer awareness and a well-developed healthcare system.

Europe

Europe also represents a substantial market, driven by the prevalence of skin diseases and the availability of advanced healthcare facilities.

Asia-Pacific

The Asia-Pacific region is expected to show rapid growth due to increasing healthcare expenditure and a large population base.

Middle East & Africa and Latin America

These regions are also growing, though at a slower pace compared to the more developed markets[1][4].

Challenges and Restraints

Despite the positive growth outlook, there are challenges that the naftifine hydrochloride market faces:

High Cost

The high cost associated with naftifine hydrochloride ointments and gels can be a deterrent for some consumers, particularly in regions with lower disposable incomes[4].

Competition

The antifungal market is competitive, with various other treatments available. This competition can impact the market share of naftifine hydrochloride products[3].

Key Players

Several companies are prominent in the naftifine hydrochloride market, including:

Merz Dermatology

Known for their Naftin brand, Merz Dermatology is a leading player in the market[5].

Parchem Fine and Specialty Chemicals

Other key players include Parchem Fine and Specialty Chemicals, LGM Pharma, Sebela Pharmaceuticals, and several others[4].

Consumer Behavior and Preferences

Consumer behavior plays a crucial role in the market dynamics of naftifine hydrochloride. There is a growing preference for products that are effective, safe, and easy to use. The versatility of naftifine hydrochloride ointments and gels in treating various skin conditions across different age groups is a significant factor in their popularity[4].

Economic, Political, and Social Landscapes

The economic, political, and social landscapes of different regions influence the market for naftifine hydrochloride. Factors such as national GDP, healthcare policies, and consumer spending habits can impact market growth and penetration[1].

Conclusion

The naftifine hydrochloride market is poised for significant growth driven by increasing demand for antifungal treatments, growing awareness about skin health, and the product's versatility and safety profile. Despite challenges such as high costs and competition, the market is expected to expand substantially over the forecast period.

Key Takeaways

• Market Growth: The naftifine hydrochloride API market is expected to grow significantly from 2023 to 2031.
• Segmentation: The market is segmented by type, application, and geographical region.
• Drivers: Increasing prevalence of skin diseases, growing awareness about skin care, and demand for versatile products drive market growth.
• Safety Profile: Naftifine hydrochloride has a well-established safety profile with no significant safety concerns identified.
• Regional Analysis: Key regions include North America, Europe, Asia-Pacific, and others.
• Challenges: High cost and competition are potential restraints.

FAQs

What is the projected growth rate of the naftifine hydrochloride API market?

The naftifine hydrochloride API market is expected to grow at a robust rate from 2023 to 2031, though the exact CAGR is not specified in the sources provided[1].

What are the main applications of naftifine hydrochloride?

Naftifine hydrochloride is primarily used in ointments and gels for treating fungal infections such as athlete's foot, jock itch, and ringworm[2][4].

Which regions are key markets for naftifine hydrochloride?

Key regions include North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1][4].

What are the major drivers of the naftifine hydrochloride market?

The major drivers include the increasing prevalence of skin diseases, growing awareness about skin care, and the rising demand for versatile antifungal products[4].

Who are the key players in the naftifine hydrochloride market?

Key players include Merz Dermatology, Parchem Fine and Specialty Chemicals, LGM Pharma, and several others[4].

Is naftifine hydrochloride safe for pediatric use?

There have been no pediatric safety concerns identified with naftifine hydrochloride, and it is considered safe for use in children[2].

Sources

1. Market Research Intellect: Naftifine Hydrochloride API Market Size, Scope And Forecast Report.
2. FDA: Naftin (Naftifine hydrochloride) - FDA.
3. OpenPR: Athlete′s Foot Drugs Market: Global Trends, Demand, and Regional Opportunities Forecast through 2031.
4. Industry Growth Insights: Naftifine Hydrochloride Ointment Market Report | Global Forecast To ...
5. FDA: Drug Approval Package: Naftin (naftifine hydrochloride) NDA #204286.