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 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
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997		OTC	Yes	Yes

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
Janssen Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990
Janssen Pharms	NIZORAL	ketoconazole	TABLET;ORAL	018533-001	Approved Prior to Jan 1, 1982
Janssen Pharms	NIZORAL	ketoconazole	SHAMPOO;TOPICAL	019927-001	Aug 31, 1990
Janssen Pharma	NIZORAL	ketoconazole	CREAM;TOPICAL	019084-001	Dec 31, 1985

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
U.S.S.R.	786899	METHOD OF PREPARING DERIVATIVES OF 1-(1,3-DIOXOLAN-2-YL-METHYL)-1H-IMIDAZOLES OR -1H-1,2,4-TRIAZOLES OR THEIR ACID-ADDITIVE SALTS IN THE FORM OF MIXTURE OR INDIVIDUAL STEREOISOMERS
Canada	1094559	1-(1,3 DIOXOLAN-2-YLMETHYL)-1H-IMIDAZOLES ET 1H-1,2,4- TRIAZOLES (1-(1,3-DIOXOLAN-2-YLMETHYL)-1H-IMIDAZOLES AND 1H-1,2, 4-TRIAZOLES)
Hungary	177646	PROCESS FOR PRODUCING NEW 1-BRACKET-1,3-DIOXOLANE-2-YL-METHYL-BRACKET CLOSED-1H-IMIDASOLE DERIVATIVES
Poland	113973
Belgium	896321
South Korea	810000675
Austria	A63678

Market Dynamics and Financial Trajectory for NIZORAL (Ketoconazole)

Last updated: July 29, 2025

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Introduction

NIZORAL, a well-established pharmaceutical product primarily containing the active ingredient ketoconazole, has occupied a significant niche within antifungal therapies since its inception. Originally marketed by Johnson & Johnson, NIZORAL has evolved from a prescription antifungal to an over-the-counter (OTC) solution in some markets. Analyzing its market dynamics and financial trajectory provides insights into competitive positioning, regulatory developments, and future growth potential within the global pharmaceutical landscape.

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Market Overview of NIZORAL

Product Profile and Therapeutic Use

NIZORAL (ketoconazole) functions as a broad-spectrum antifungal agent, targeting dermatophyte infections, candidiasis, and seborrheic dermatitis. It is available in various formulations, including topical creams, shampoos, and tablets. Although systemic uses have declined due to safety concerns, topical formulations remain integral in dermatology.

Market Penetration and Evolution

Initially launched as a prescription drug in the 1980s, NIZORAL experienced widespread adoption owing to its efficacy. Its market share was reinforced through aggressive marketing and broad-spectrum activity. However, regulatory agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) imposed restrictions on systemic ketoconazole due to hepatotoxicity risks—impacting the drug’s market trajectory significantly.

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Regulatory Landscape and Its Impact

Safety Concerns and Market Restrictions

In 2013, the FDArevoked the approval of oral ketoconazole for systemic fungal infections, citing risks of liver injury, adrenal failure, and drug interactions. Similarly, EMA restricted its systemic use within the European Union in 2014. Consequently, manufacturers, including Johnson & Johnson, shifted focus away from systemic formulations towards topical products, which remain safer and are now the primary revenue drivers.

OTC Market Expansion

In 2017, Johnson & Johnson transitioned NIZORAL shampoo to OTC availability in several geographies, including the U.S. and Europe, capitalizing on consumer demand for self-medication for dandruff and seborrheic dermatitis. This shift antiviralized the product’s market position, facilitating broader accessibility and increased sales.

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Market Dynamics

Competitive Landscape

The antifungal market is highly competitive, with several brands, including Selsun, Head & Shoulders, and Nizoral (skin), vying for market dominance. NIZORAL’s unique position as a prescription and OTC product allows it to capture diverse customer segments.

Emerging Competition and Alternatives

Newer antifungal agents, such as terbinafine and ciclopirox, have gained popularity due to favorable safety profiles and efficacy. These alternatives have challenged NIZORAL’s market share, especially for systemic applications. However, NIZORAL’s safety, affordability, and established efficacy maintain its relevance.

Market Trends

The global antifungal market is projected to grow at a CAGR of approximately 4-6% over the next five years, driven by increased dermatological conditions, aging populations, and rising awareness. The OTC segment is expected to expand faster, with consumers favoring at-home treatments, which benefits NIZORAL’s OTC shampoo formulations.

Geographical Markets

Developed markets like North America and Europe are mature, with competitive pressure and regulatory restrictions influencing growth. Emerging markets in Asia-Pacific, Latin America, and the Middle East present significant growth opportunities due to rising prevalence of fungal infections and improving healthcare infrastructure.

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Financial Trajectory

Historical Revenue and Market Share

Johnson & Johnson’s dermatology segment, which includes NIZORAL, reported revenues exceeding $12 billion annually (2021). NIZORAL’s contribution is predominantly from topical formulations, with estimates placing the global shampoo market segment of ketoconazole at over $700 million (2022 data). While precise revenue attribution remains proprietary, NIZORAL’s brand strength suggests it maintains a substantial share within antifungal OTC products.

Pricing and Profitability

NIZORAL maintains competitive pricing, leveraged by its brand recognition. Gross margins for topical dermatology products typically range between 60-70%, with substantial profit potential, barring market disruptions or patent cliffs. As the patent for NIZORAL expired in many regions, generic competition has emerged, exerting downward pressure on prices.

Impact of Patent Expiry and Generics

The patent expiration in key territories generally results in a rapid decline in branded sales, replaced by generics, which typically lead to 20-30% lower prices. Nonetheless, brand loyalty and OTC availability sustain a steady revenue flow, especially in markets with high awareness.

Forecasting Future Revenues

Considering safety concerns, the systemic formulation sales are unlikely to recover. The OTC shampoo segment is anticipated to grow at a CAGR of approximately 5% over the next five years, driven by consumer preference for self-care and expanding dermatological indications. If Johnson & Johnson maintains market dominance and leverages distribution channels effectively, revenues from NIZORAL topical products could grow modestly or stabilize, barring significant competitive disruptions.

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Strategic Factors Influencing Market and Financial Outcomes

Regulatory Developments

Continued scrutiny of dermatological antifungals and potential restrictions could impact formulation availability and market size. Regulatory agencies may impose new safety mandates or restrict formulations with systemic exposure.

Innovation and Formulation Advancements

However, innovation in delivery systems—such as enhanced shampoos or combination therapies—can extend product lifecycles. Johnson & Johnson’s investment in such innovations could boost market share and profitability.

Market Penetration in Emerging Economies

Expanding into emerging markets, aided by increased healthcare access and rising fungal infection prevalence, could elevate revenues. Localization strategies and cost-effective formulations will be critical.

Consumer Trends

Growing consumer awareness of dandruff and fungal skin conditions sustains demand. The shifting landscape toward OTC self-treatment aids NIZORAL’s positioning as a trusted brand.

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Key Takeaways

• Regulatory shifts have curtailed systemic ketoconazole use, emphasizing topical formulations and OTC sales, transforming NIZORAL’s market dynamics.
• Market competition from alternative antifungals, particularly oral terbinafine and topical ciclopirox, challenges NIZORAL’s market share but is offset by brand loyalty and safety perceptions.
• Geographical expansion into emerging markets presents growth opportunities, particularly for OTC formulations.
• Patent expiries and generic entries have moderately impacted revenue, but brand strength and OTC accessibility maintain profitability.
• Innovation and marketing will be critical for sustaining growth amid competitive and regulatory pressures.

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FAQs

1. What are the primary uses of NIZORAL today?
NIZORAL is mainly used as a topical antifungal for dandruff, seborrheic dermatitis, and superficial skin infections. Systemic uses are largely discontinued due to safety concerns.

2. How have regulatory changes influenced NIZORAL’s market?
Regulatory agencies restricted systemic ketoconazole because of hepatotoxicity risks, shifting focus to OTC topical formulations, which have expanded market access but limited systemic sales growth.

3. Is NIZORAL facing significant competition in the antifungal market?
Yes, competitors like terbinafine, clotrimazole, and newer formulations pose challenges, especially for systemic indications. However, NIZORAL maintains a strong position in scalp and skin treatments.

4. What are the growth prospects for NIZORAL in emerging markets?
Emerging economies offer substantial growth opportunities due to increasing prevalence of fungal infections and improved healthcare infrastructure, with OTC formulations facilitating easier market penetration.

5. How will patent expiries impact NIZORAL’s future revenues?
Patent expiries have led to generic competition, reducing prices and revenues. Nonetheless, strong brand recognition and OTC availability are expected to stabilize a significant portion of sales.

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References

[1] Johnson & Johnson Annual Reports, 2021
[2] Market Research Future, "Global Antifungal Market Analysis," 2022
[3] FDA Updates on Ketoconazole, 2013
[4] EMA Safety Guidelines on Systemic Antifungals, 2014