NIZORAL Drug Patent Profile

Which patents cover Nizoral, and what generic alternatives are available?

Nizoral is a drug marketed by Janssen Pharma, Janssen Pharms, and Kramer. and is included in five NDAs.

The generic ingredient in NIZORAL is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nizoral

A generic version of NIZORAL was approved as ketoconazole by TARO on June 15^th, 1999.

Summary for NIZORAL

US Patents:	0
Applicants:	3
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	34
Patent Applications:	2,243
Drug Prices:	Drug price information for NIZORAL
What excipients (inactive ingredients) are in NIZORAL?	NIZORAL excipients list
DailyMed Link:	NIZORAL at DailyMed

See drug prices for NIZORAL

See drug sales revenues for NIZORAL

Recent Clinical Trials for NIZORAL

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

Sponsor	Phase
Hospital Universitario Dr. Jose E. Gonzalez	Phase 2
Fernando De la Garza Salazar	Phase 2
Milton S. Hershey Medical Center	Early Phase 1

See all NIZORAL clinical trials

US Patents and Regulatory Information for NIZORAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharma	NIZORAL	ketoconazole	CREAM;TOPICAL	019084-001	Dec 31, 1985		DISCN	Yes	No
Janssen Pharms	NIZORAL	ketoconazole	TABLET;ORAL	018533-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Janssen Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990		DISCN	Yes	No
Janssen Pharma	NIZORAL	ketoconazole	SUSPENSION;ORAL	070767-001	Nov 7, 1986		DISCN	No	No

Expired US Patents for NIZORAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharma	NIZORAL	ketoconazole	CREAM;TOPICAL	019084-001	Dec 31, 1985	4,335,125
Janssen Pharma	NIZORAL	ketoconazole	CREAM;TOPICAL	019084-001	Dec 31, 1985	4,942,162
Janssen Pharms	NIZORAL	ketoconazole	TABLET;ORAL	018533-001	Approved Prior to Jan 1, 1982	4,335,125
Janssen Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990	4,942,162

EU/EMA Drug Approvals for NIZORAL

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

International Patents for NIZORAL

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

Country	Patent Number	Title	Estimated Expiration
Philippines	14635	1-(1,3-DIOKOLAN-2-YIMETHYL)-1H-IMIDAZOLES AND 1H-12,4-TRIAZOLES
Greece	62553	NOVEL 1-(1,3-DIOXALAN-2-YLMETHYL)-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES
Finland	780294
Netherlands	7801048

Market Dynamics and Financial Trajectory for NIZORAL

Last updated: February 28, 2026

What is the Current Market Position of NIZORAL (Ketoconazole)?

NIZORAL, the brand name for ketoconazole, is a topical and oral antifungal medication approved by the FDA primarily for fungal infections. It has faced regulatory and market shifts over recent years that impact its sales, usage, and competitive position.

The drug's sales peaked in the early 2010s, driven by strong demand for its topical formulations. Since then, sales have declined due to safety concerns and competition from newer antifungal agents.

How Has Regulatory Action Affected NIZORAL's Market Access?

In 2013, the FDA limited oral ketoconazole’s indications and warned against its systemic use due to hepatotoxicity risks. The agency requested label updates emphasizing risks associated with the drug, discouraging off-label uses for systemic antifungal therapy.

As a result, prescriptions for oral ketoconazole declined sharply. The drug's use shifted mainly to topical formulations, which have less systemic absorption and lower hepatotoxicity risk.

What Are the Key Drivers of Market Dynamics?

1. Safety Profile and Regulatory Restrictions

Hepatotoxicity concerns led to the restriction of oral ketoconazole. The off-label use of systemic formulations decreased by approximately 70% between 2013 and 2018, according to IMS Health data.

2. Competition from Improved Antifungal Agents

New systemic antifungals, such as voriconazole, posaconazole, and isavuconazole, have better safety profiles. Their increased efficacy and lower toxicity have dominated the systemic antifungal market, reducing NIZORAL’s share.

3. Clinical Preference for Topical Use

Topical ketoconazole remains prescribed for dermatophyte infections, dandruff, and seborrheic dermatitis. However, OTC availability for dandruff shampoos containing ketoconazole (e.g., NIZORAL Shampoo) boosts volume at lower margins.

4. Patent and Formulation Challenges

NIZORAL's markets are mature, with limited patent protection. The company faces price erosion and generic competition in topical formulations, which accounts for a significant share of sales.

5. Regional Variability

Emerging markets exhibit increased demand for topical antifungals, including ketoconazole, driven by dermatological needs and lower prices of generics.

What Is the Financial Trajectory?

Revenue Trends

Global sales of NIZORAL (including all formulations) declined from $540 million in 2013 to approximately $290 million in 2022, representing a compound annual decline rate (CAGR) of roughly 7.7%. The decline is primarily attributable to reduced systemic use and price erosion in topical markets.

Revenue Breakdown

Formulation	2013 Revenue	2022 Revenue	Change (%)	Comments
Oral	~$150 million	<$20 million	-87%	Regulatory restrictions, safety concerns
Topical (Prescription & OTC)	~$390 million	~$270 million	-30%	OTC sales offset some decline

Market Projections

The overall NIZORAL market is expected to decline further, with forecasts projecting a 4.5% annual drop through 2025 due to continued competition and regulatory constraints.

Margin and Cost Considerations

Gross margins in topical segments remain high, around 70%. However, increased generic competition in the OTC market has driven prices down, diminishing profit margins.

How Do Competitive and Regulatory Trends Influence Future Outlook?

The shift toward newer antifungals will likely continue, especially in systemic applications. NIZORAL’s future depends heavily on its topical formulations, which face sustained generic competition and OTC pricing pressures.

Potential growth avenues are limited but include increased demand for topical products in emerging markets and expansion into adjunct therapies for dermatological conditions. The drug’s position in OTC dandruff shampoos offers a steady revenue stream but with low margins.

What Are the Implications for Stakeholders?

• Investors should expect continued revenue decline outside of niche markets.
• R&D focus may shift toward reformulation or combination products addressing unmet dermatological needs.
• Regulatory constraints will influence formulations and indications, constraining market expansion.

Key Takeaways

• NIZORAL’s systemic use has declined sharply due to safety concerns.
• Topical formulations continue to generate significant revenue but face price erosion.
• Newer antifungals dominate systemic indications, limiting growth.
• Market growth prospects are limited, with continued decline expected through 2025.
• Regional growth in emerging markets offsets some declines but remains modest.

FAQs

1. Will NIZORAL regain systemic approval?
No. Safety concerns and regulatory restrictions effectively prevent reintroduction for systemic indications.

2. Can topical NIZORAL increase market share?
Limited potential exists due to generic competition and OTC market saturation.

3. Are newer antifungals replacing ketoconazole?
Yes, especially in systemic applications, driven by improved safety profiles.

4. What regional markets show growth potential?
Emerging markets where dermatological infections are prevalent and generic topical formulations are accessible.

5. Is there pipeline activity for NIZORAL?
No significant pipeline exists for reformulations or new indications, emphasizing its mature market status.

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References:
[1] U.S. Food & Drug Administration. (2013). Ketoconazole (systemic) label update.
[2] IMS Health. (2018). U.S. prescription trends.
[3] MarketWatch. (2022). Topical antifungal market analysis.
[4] EvaluatePharma. (2023). Global antifungal drug market forecast.