EFINACONAZOLE - Generic Drug Details

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

Efinaconazole is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Lupin Ltd, Padagis Us, Teva Pharms Usa, Umedica, Zydus Lifesciences, and Bausch, and is included in seven NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efinaconazole has eighty-five patent family members in twenty-four countries.

There are fourteen drug master file entries for efinaconazole. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for EFINACONAZOLE

International Patents:	85
US Patents:	18
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	5
Patent Applications:	545
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EFINACONAZOLE
What excipients (inactive ingredients) are in EFINACONAZOLE?	EFINACONAZOLE excipients list
DailyMed Link:	EFINACONAZOLE at DailyMed

Recent Clinical Trials for EFINACONAZOLE

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

Sponsor	Phase
Dong-A ST Co., Ltd.	Phase 4
Western University of Health Sciences	Phase 3
Valeant Pharmaceuticals International, Inc.	Phase 4

See all EFINACONAZOLE clinical trials

Generic filers with tentative approvals for EFINACONAZOLE

Applicant	Application No.	Strength	Dosage Form
		10%	SOLUTION;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for EFINACONAZOLE

Drug Class

Azole Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for EFINACONAZOLE

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for EFINACONAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JUBLIA	Topical Solution	efinaconazole	10%	203567	19	2018-06-06

US Patents and Regulatory Information for EFINACONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	10,828,293
Bausch	JUBLIA	efinaconazole	SOLUTION;TOPICAL	203567-001	Jun 6, 2014	AB	RX	Yes	Yes	11,213,519
Teva Pharms Usa	EFINACONAZOLE	efinaconazole	SOLUTION;TOPICAL	211827-001	Dec 16, 2020	AB	RX	No	No

International Patents for EFINACONAZOLE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2112228
Japan	2020169207	安定化エフィナコナゾール組成物 (STABILIZED EFINACONAZOLE COMPOSITIONS)
Japan	2017500374	抗感染方法、抗感染組成物、および抗感染装置

EFINACONAZOLE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Efinaconazole

Introduction to Efinaconazole

Efinaconazole is a triazole antifungal agent specifically designed for the treatment of onychomycosis, a fungal infection of the nails. The drug has gained significant attention due to its efficacy and safety profile, making it a crucial player in the antifungal market.

Market Size and Growth

The global efinaconazole market has been experiencing steady growth. As of 2019, the market size was valued at approximately USD 770 million and is projected to reach USD 875 million by 2026, growing at a compound annual growth rate (CAGR) of 3.2% from 2020 to 2026[1].

Key Drivers of the Market

Several factors are driving the growth of the efinaconazole market:

• Increasing Prevalence of Fungal Nail Infections: The rising incidence of onychomycosis, particularly among diabetic patients and those with chronic diseases, is a significant driver. Approximately 34% of diabetic patients have onychomycosis, making them almost three times more likely to develop the condition than non-diabetic patients[3].
• Demand for Effective Treatment Options: The need for efficient and safe treatments for fungal nail infections is on the rise, driven by consumer awareness and the aesthetic appeal of healthy nails[3].
• Technological Advancements: Improvements in drug formulations and delivery systems enhance the efficacy and convenience of efinaconazole, making it more attractive to patients and healthcare providers[2].
• Strategic Collaborations and Partnerships: Collaborations with research institutes and other pharmaceutical companies facilitate innovation and expansion of product portfolios[2].

Regional Analysis

The efinaconazole market exhibits regional variations:

• North America and Europe: These regions currently dominate the market due to a higher prevalence of fungal nail infections and the presence of established pharmaceutical companies[2].
• Asia Pacific, Latin America, and Middle East & Africa: These regions are witnessing significant growth driven by a growing aging population, improving healthcare infrastructure, and increasing awareness about nail health[2].

Market Segmentation

The efinaconazole market is segmented based on several criteria:

• Type: The market is classified into purity above 98% and purity below 98%[1][3].
• Application: The primary application is the treatment of onychomycosis, with other applications also being considered[1][3].
• End User: Key end users include hospitals, dermatology and podiatry clinics, independent pharmacies, mail order pharmacies, and drug stores[3].

SWOT Analysis

A SWOT analysis provides insights into the market's internal and external factors:

• Strengths:

  • Efinaconazole is an effective treatment for fungal nail infections, offering a competitive advantage.
  • Growing awareness about nail health and the importance of treating fungal infections.
  • Technological advancements in drug formulations enhance efficacy and convenience[2].

• Weaknesses:

  • High cost of treatment may limit adoption, especially in regions with limited financial resources.
  • Potential side effects and allergic reactions could deter some individuals.
  • Stringent regulatory requirements pose challenges for market entry and product approvals[2].

• Opportunities:

  • Untapped emerging markets present opportunities for market expansion.
  • Development of combination therapies can enhance treatment outcomes and market potential.
  • Online sales channels provide a convenient platform for medication distribution[2].

• Threats:

  • Availability of alternative treatment options, such as oral antifungal medications and laser therapies, could impact market share.
  • Intense competition among market players may result in pricing pressures.
  • Adverse events or safety concerns related to efinaconazole could impact market perception[2].

Financial Trajectory

The financial trajectory of the efinaconazole market is promising:

• Revenue Generation: The increasing demand for effective treatment options and the growing prevalence of fungal nail infections contribute to revenue growth. The market is expected to generate significant revenue for pharmaceutical companies, distributors, and retailers[2].
• Market Expansion: Pharmaceutical companies can expand their market presence by introducing efinaconazole in new regions and targeting emerging markets. This expansion allows companies to tap into previously untapped consumer bases and increase their market share[2].
• Innovation and Differentiation: Research and development efforts in efinaconazole formulation and delivery systems enable companies to introduce innovative products and differentiate themselves from competitors. This innovation helps companies attract new customers and retain existing ones[2].

Impact of COVID-19

The COVID-19 pandemic had a short-term impact on the efinaconazole market:

• Reduced Hospital Admissions: The pandemic led to reduced hospital admissions for the diagnosis and treatment of onychomycosis, resulting in lower sales during the epidemic period[3].
• Shift in Healthcare Priorities: National healthcare priorities and spending shifted towards COVID-19 treatment, temporarily affecting the onychomycosis treatment market[3].

Key Market Players

Several key players are active in the efinaconazole market:

• Kaken Pharmaceutical Co., Ltd.
• Procos S.p.A.
• Topharman
• CHEMVON BIOTECHNOLOGY (SHANGHAI) CO. LTD.
• Taizhou Volsen Chemical Co., Ltd.
• Valeant Pharmaceuticals International, Inc.
• Zhejiang Ausun Pharmaceutical Co., Ltd.
• Tenova Pharmaceuticals Inc.
• Viwit Pharmaceuticals Limited
• RXN Chemicals Pvt. Ltd.[1][3].

Future Outlook

The future outlook for the efinaconazole market is optimistic:

• Sustained Growth: The market is expected to witness sustained growth driven by the rising prevalence of fungal nail infections, increasing awareness about nail health, technological advancements, and expanding healthcare infrastructure in emerging markets[2].
• Innovative Formulations: Pharmaceutical companies are likely to focus on developing innovative formulations, combination therapies, and advanced drug delivery systems to enhance treatment outcomes and patient compliance[2].
• Market Expansion: Expansion into untapped markets, strategic collaborations, and investments in research and development activities will remain key strategies for market players[2].

Key Takeaways

• The efinaconazole market is growing steadily, driven by increasing prevalence of fungal nail infections and demand for effective treatments.
• Technological advancements and strategic collaborations are key drivers of market growth.
• The market is segmented by type, application, and region, with North America and Europe currently dominating.
• Emerging markets in Asia Pacific, Latin America, and the Middle East & Africa present significant opportunities.
• The market faces challenges such as high treatment costs and regulatory requirements but is poised for significant growth.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the efinaconazole market? A: As of 2019, the global efinaconazole market size was valued at approximately USD 770 million[1].

Q: What is the projected growth rate of the efinaconazole market? A: The market is expected to grow at a CAGR of 3.2% from 2020 to 2026[1].

Q: Which regions dominate the efinaconazole market? A: North America and Europe currently dominate the market, but significant growth is expected in Asia Pacific, Latin America, and the Middle East & Africa[2].

Q: What are the key drivers of the efinaconazole market? A: Key drivers include the increasing prevalence of fungal nail infections, demand for effective treatment options, technological advancements, and strategic collaborations[2].

Q: How did the COVID-19 pandemic impact the efinaconazole market? A: The pandemic had a short-term impact, reducing hospital admissions for onychomycosis treatment and shifting healthcare priorities towards COVID-19 treatment[3].

Cited Sources

1. Facts & Factors: Efinaconazole Market Size, Growth, Global Trends, Forecast to 2026.
2. MarkWide Research: Efinaconazole Market 2024-2032 | Size, Share, Growth.
3. EIN Presswire: Efinaconazole Market Analysis Insights by Latest Trends, Future Growth, Revenue and Demand.