Ketoconazole - Generic Drug Details

What are the generic sources for ketoconazole and what is the scope of patent protection?

Ketoconazole is the generic ingredient in six branded drugs marketed by Norvium Bioscience, Padagis Israel, Xiromed, Encube, Fougera Pharms, Teva, Trupharma, Taro, Janssen Pharma, Almirall, Cosette, Novitium Pharma, Janssen Pharms, Kramer, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, and Sun Pharm Industries, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for ketoconazole. Twenty-eight suppliers are listed for this compound.

Summary for ketoconazole

US Patents:	0
Tradenames:	6
Applicants:	21
NDAs:	26
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	243
Patent Applications:	7,388
Drug Prices:	Drug price trends for ketoconazole
Drug Sales Revenues:	Drug sales revenues for ketoconazole
What excipients (inactive ingredients) are in ketoconazole?	ketoconazole excipients list
DailyMed Link:	ketoconazole at DailyMed

See drug prices for ketoconazole

See drug sales revenues for ketoconazole

Recent Clinical Trials for ketoconazole

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

Sponsor	Phase
Fernando De la Garza Salazar	Phase 2
Hospital Universitario Dr. Jose E. Gonzalez	Phase 2
Universitas Padjadjaran	Phase 4

See all ketoconazole clinical trials

Pharmacology for ketoconazole

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for ketoconazole

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ketoconazole

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

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

H02CA	Anticorticosteroids
H02C	ANTIADRENAL PREPARATIONS
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

J02AB	Imidazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for KETOCONAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXTINA	Foam	ketoconazole	2%	021738	1	2009-07-30

US Patents and Regulatory Information for ketoconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997		OTC	Yes	Yes
Janssen Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990		DISCN	Yes	No
Encube	KETOCONAZOLE	ketoconazole	CREAM;TOPICAL	212443-001	May 20, 2021	AB	RX	No	No
Senores Pharms	KETOCONAZOLE	ketoconazole	TABLET;ORAL	075912-001	Jan 10, 2002	AB	RX	No	No
Padagis Israel	KETOCONAZOLE	ketoconazole	SHAMPOO;TOPICAL	076419-001	Jan 7, 2004	AB	RX	No	Yes

Expired US Patents for ketoconazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997	4,335,125
Almirall	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006	7,179,475
Janssen Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990	4,942,162
Norvium Bioscience	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007	7,553,835
Almirall	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006	8,735,393

EU/EMA Drug Approvals for ketoconazole

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
HRA Pharma Rare Diseases	Ketoconazole HRA	ketoconazole	EMEA/H/C/003906 Ketoconazole HRA is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.	Authorised	no	no	yes	2014-11-18

Ketoconazole Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ketoconazole

Market Overview

The ketoconazole market is experiencing significant growth, driven by several key factors. As of 2023, the global ketoconazole market was valued at USD 782.3 million and is projected to reach USD 1.2 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.6% from 2024 to 2031[1].

Driving Factors

Increasing Prevalence of Fungal Infections

The rising incidence of fungal infections, particularly in tropical and subtropical regions, is a major driver of the ketoconazole market. This increase is attributed to compromised immune systems and the adaptation of harmful pathogens to warmer temperatures[4].

Growing Demand for Antifungal Medications

There is a growing need for potent antifungal medications like ketoconazole, which is fueling market growth. The increased awareness and accessibility of over-the-counter antifungal drugs have expanded the market reach[1].

Expansion of the Pharmaceutical Sector

The continuous growth and development of the pharmaceutical sector, along with ongoing research and development of new formulations, are enhancing the market potential for ketoconazole. Pharmaceutical companies are investing heavily in finding new therapeutic options, which includes the development of antifungal agents[4].

Rising Prevalence of Skin Diseases

The increasing prevalence of skin diseases such as seborrheic dermatitis and dandruff, which can be effectively treated with ketoconazole-based treatments, is another significant factor driving market growth[1].

Market Segmentation

By Application

The ketoconazole market is segmented into various applications, including fungal infections, dermatological conditions, seborrheic dermatitis, dandruff, and tinea infections. The antifungal segment holds a significant share due to the surge in compromised immune systems and the adaptation of harmful pathogens[4].

By Product Type

The market is segmented by product type into ketoconazole cream, shampoo, tablets, solution, and foam. The ketoconazole topical segment, particularly the shampoo, has a substantial market share due to its effectiveness in treating scalp conditions like dandruff[4].

Geographical Analysis

Regional Growth

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region is expected to grow with the highest CAGR during the forecast period due to the growing number of ketoconazole manufacturing companies and increased demand for skincare products in this region[4].

Country-Specific Trends

North America is also a significant market, with the U.S. annual sales for ketoconazole shampoo alone totaling approximately $69.2 million as of July 2024. This indicates a strong demand for ketoconazole products in this region[3].

Competitive Landscape

Key Players

The market is competitive, with key players such as Mylan, Johnson & Johnson, and ANI Pharmaceuticals. These companies are focusing on expanding their product portfolios and launching new products to address patient needs. For instance, ANI Pharmaceuticals recently received FDA approval and launched a generic version of ketoconazole shampoo, 2%, which is expected to boost their revenue and market presence[3].

Strategic Moves

Companies are implementing various strategies to strengthen their market position. This includes new product launches, expansions, mergers and acquisitions, and partnerships. The competitive landscape is further analyzed through Porter’s Five Forces analysis, which includes buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the degree of competition[1].

Financial Trajectory

Market Size and Growth

The ketoconazole market is expected to grow significantly, with a projected market size of USD 1.2 billion by 2031. This growth is driven by the increasing demand for antifungal medications and the expanding pharmaceutical sector[1].

Revenue and Profit Margins

The launch of new products, such as ANI Pharmaceuticals' ketoconazole shampoo, is expected to contribute to revenue growth. However, the actual impact will depend on the company's ability to capture market share and compete with other generic versions. Generic drug pricing can be competitive, so manufacturing efficiency and distribution strategies will be crucial in determining profit margins[3].

Challenges and Opportunities

Competition and Pricing

The market faces competition from both branded and generic products, which can impact pricing and profit margins. However, the growing demand for antifungal medications presents a significant opportunity for companies to expand their market share[3].

Regulatory Approvals

Regulatory approvals, such as the FDA approval for ANI Pharmaceuticals' ketoconazole shampoo, are critical for market entry and growth. Companies must navigate regulatory landscapes to ensure timely and successful product launches[3].

Technological and R&D Trends

Advances in Formulations

The market is witnessing advances in formulations, with a focus on developing better therapeutic options. Companies are investing in research and development to create more effective and safer antifungal agents[4].

Emerging Technologies

Emerging technologies, such as improved fungal control and better product constitutions, are trends in the ketoconazole market. These advancements are expected to enhance the efficacy and safety of ketoconazole products[4].

Consumer Behavior and Market Trends

Increasing Urban Population

The rising urban population and changing lifestyles are contributing to the increased demand for skincare products, including antifungal medications. This trend is particularly evident in the Asia-Pacific region[4].

Consumer Awareness

Increased consumer awareness of antifungal therapies and the availability of over-the-counter antifungal drugs are driving market growth. Consumers are becoming more health-conscious, leading to higher demand for effective treatments[1].

Key Takeaways

• The ketoconazole market is valued at USD 782.3 million in 2023 and is expected to reach USD 1.2 billion by 2031.
• The market is driven by the increasing prevalence of fungal infections, growing demand for antifungal medications, and the expansion of the pharmaceutical sector.
• The Asia-Pacific region is expected to grow with the highest CAGR during the forecast period.
• Key players are focusing on new product launches and strategic expansions to capture market share.
• Regulatory approvals and technological advancements are crucial for market growth.

Frequently Asked Questions (FAQs)

Q1: What is the current market size of the ketoconazole market?

The ketoconazole market was valued at USD 782.3 million in 2023[1].

Q2: What is the expected CAGR of the ketoconazole market from 2024 to 2031?

The ketoconazole market is expected to grow at a CAGR of 4.6% from 2024 to 2031[1].

Q3: Which region is expected to grow with the highest CAGR during the forecast period?

The Asia-Pacific region is expected to grow with the highest CAGR during the forecast period[4].

Q4: What are the main driving factors for the growth of the ketoconazole market?

The main driving factors include the increasing prevalence of fungal infections, growing demand for antifungal medications, and the expansion of the pharmaceutical sector[1].

Q5: Which segment has the largest share of the ketoconazole market by product type?

The ketoconazole topical segment, particularly the shampoo, has a substantial market share[4].

Cited Sources:

1. Market Research Intellect: Ketoconazole Market Size, Share and Forecast to 2031
2. Cognitive Market Research: Ketoconazole Market Report 2024 (Global Edition)
3. Stock Titan: ANI Pharmaceuticals Announces the FDA Approval and Launch of Ketoconazole Shampoo, 2%
4. UnivDatos: Ketoconazole Market: Share, Size, Trends, Growth & Forecast to 2030