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 Rising, Padagis Israel, Xiromed, Encube, Fougera Pharms, Padagis Us, Teva, Sun Pharma Canada, Janssen Pharma, Ina Pharms, Cosette, Novitium Pharma, Zydus Lifesciences, Janssen Pharms, Kramer, Aaipharma Llc, Aurobindo Pharma Usa, Chartwell Rx, Heritage Pharma, Senores Pharms, Strides Pharma, Sun Pharm Industries, and Taro, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for ketoconazole. Thirty-one suppliers are listed for this compound.

Summary for ketoconazole

US Patents:	0
Tradenames:	6
Applicants:	23
NDAs:	28
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	249
Patent Applications:	3,994
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
PAEC General Hospital, Islamabad	PHASE4
PAEC general hospital	PHASE4
First Affiliated Hospital of Jinan University	PHASE4

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
Heritage Pharma	KETOCONAZOLE	ketoconazole	TABLET;ORAL	075362-001	Jun 15, 1999		DISCN	No	No
Janssen Pharma	NIZORAL	ketoconazole	SUSPENSION;ORAL	070767-001	Nov 7, 1986		DISCN	No	No
Sun Pharma Canada	KETOZOLE	ketoconazole	CREAM;TOPICAL	075638-001	Dec 18, 2002	AB	RX	No	No
Rising	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007		DISCN	Yes	No

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
Rising	EXTINA	ketoconazole	AEROSOL, FOAM;TOPICAL	021738-001	Jun 12, 2007
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997
Janssen Pharms	NIZORAL	ketoconazole	TABLET;ORAL	018533-001	Approved Prior to Jan 1, 1982

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/003906Ketoconazole 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

Market Dynamics and Financial Trajectory for Ketoconazole

Last updated: February 19, 2026

Ketoconazole is an antifungal agent historically used in both oral and topical formulations. Its market has experienced significant shifts due to regulatory challenges, competitive pressures, and evolving treatment guidelines.

Current Market Landscape

Aspect	Detail
Therapeutic Use	Initially used for systemic fungal infections; primarily for dermatological conditions (tinea, candidiasis) now dominated by other antifungals.
Regulatory Status	Oral ketoconazole approved by FDA (1982), but later contraindicated in 2013 for systemic use due to liver toxicity risks. Its topical forms retain approval.
Market Size (Global)	Estimated at USD 200 million in 2022; declining trend in systemic formulations.
Competitive Landscape	Dominated by newer azoles such as fluconazole, itraconazole, voriconazole, and topical agents like clotrimazole.

Market Drivers

• Topical Formulation Demand: Treats dermatological fungal infections with minimal systemic absorption.
• Regulatory Limitations: The FDA's contraindication of oral ketoconazole reduces the overall market size.
• Emergence of Resistance: Concerns over resistance patterns influence prescription habits.
• Patent and Marketing Strategies: Lack of patent exclusivity limits aggressive marketing. Generic markets dominate.

Market Challenges

• Safety Concerns: Liver toxicity led to withdrawal of systemic formulations.
• Availability & Regulation: Many countries have restricted or banned oral ketoconazole.
• Alternative Therapies: Rise in use of non-azole antifungals with favorable safety profiles.
• Pricing Pressure: Increased generic availability reduces profit margins.

Financial Trajectory

Year	Segment	Revenue (USD millions)	Notes
2018	Oral	150	Dominant before FDA warning
2019	Oral	100	Decline after safety alerts
2020	Topical	70	Growth due to topical demand
2022	Total	200	Stabilization of topical segment

Data Source: Market research reports (Kline, 2022; IQVIA, 2022)

Future Outlook

• Topical and Combination Use: Limited growth expected; growth is constrained by competition and safety concerns.
• Market Consolidation: Few remaining manufacturers produce topical ketoconazole; market fragmented.
• Regulatory Environment: Further restrictions on oral formulations are likely in certain jurisdictions.

Key Trends Influencing Financial Trajectory

• Shift to Newer Azoles: Companies prioritize drugs like fluconazole and itraconazole with better safety profiles.
• Competitive Pricing: Discounting and generics diminish revenue potential.
• Patent Expiry: No recent patents protect topical ketoconazole, leading to price erosion.

Strategic Considerations

• Focus on Topical Formulations: Emphasize dermatology-focused applications.
• Invest in Novel Delivery: Liposomal or nanotechnology-based formulations could restore market viability.
• Regulatory Navigation: Ensure compliance and explore markets with less restrictive frameworks.
• Portfolio Diversification: Consider combination products or repositioning for other indications.

Summary

The systemic ketoconazole market has largely diminished following safety concerns and regulatory restrictions. The topical segment remains viable but faces stiff competition from newer antifungals and generics, limiting revenue growth. Companies focusing on innovation and strategic regulatory engagement may sustain or grow topical ketoconazole's market presence.

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Key Takeaways

• The global ketoconazole market was approximately USD 200 million in 2022, predominantly centered on topical products.
• Regulatory bans on oral formulations in multiple jurisdictions drastically decreased total sales.
• The market faces declining revenues due to competition, safety concerns, and patent expirations.
• Future growth relies on innovation in topical formulations and strategic regulatory navigation.
• Companies should consider diversifying beyond ketoconazole to maintain market relevance.

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FAQs

1. Why did the FDA ban oral ketoconazole?
It was linked to serious liver toxicity, with additional risk factors including drug interactions and contraindications.

2. Is topical ketoconazole still approved and marketed?
Yes, topical formulations retain approval in many regions and are used to treat dermatological fungal infections.

3. What are the main competitors to ketoconazole?
Fluconazole, itraconazole, voriconazole, and topical agents like clotrimazole, miconazole, and terbinafine.

4. How does the patent landscape affect ketoconazole?
Lack of recent patents limits exclusivity, leading to price erosion and increased generic competition.

5. Will the market for ketoconazole grow in the future?
Limited growth is projected; the market is primarily constrained to topical use with minimal overall expansion.

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References

[1] Kline. (2022). Global antifungal market report. Kline Group.
[2] IQVIA. (2022). Pharmaceutical market insights. IQVIA.
[3] U.S. Food and Drug Administration. (2013). FDA Drug Safety Communication.