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. Twenty-eight 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:	47
Clinical Trials:	34
Patent Applications:	1,576
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

Expired US Patents for NIZORAL

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

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/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

International Patents for NIZORAL

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

Country	Patent Number	Title	Estimated Expiration
Finland	63398
Spain	465981
Australia	521329

NIZORAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nizoral (Ketoconazole)

Introduction

Nizoral, a brand name for the antifungal medication ketoconazole, has been a significant player in the pharmaceutical market, particularly in the treatment of fungal infections such as seborrheic dermatitis and dandruff. This article delves into the market dynamics and financial trajectory of Nizoral, highlighting key factors influencing its market position and financial performance.

Market Size and Growth

The ketoconazole market, which includes Nizoral, is projected to experience substantial growth. As of 2023, the global ketoconazole market was valued at USD 782.3 million and is expected to reach USD 1.2 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.6% from 2024 to 2031[4].

Drivers of Market Growth

Several factors are driving the growth of the ketoconazole market:

Increasing Prevalence of Fungal Infections

The rise in fungal infections, especially in tropical and subtropical regions, has increased the demand for potent antifungal medications like ketoconazole[4].

Growing Awareness and Accessibility

Increased awareness and accessibility of over-the-counter antifungal drugs have made ketoconazole more widely available to a larger audience[4].

Expansion of the Pharmaceutical Sector

The continuous expansion and innovation within the pharmaceutical sector, including the development of new formulations, are enhancing the market potential for ketoconazole[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 driver[4].

Competitive Landscape

The approval and launch of generic versions of ketoconazole, such as the recent FDA approval of ANI Pharmaceuticals' Ketoconazole Shampoo, 2%, introduce new competitors into the market. This generic version enters a market with annual sales of approximately $69.2 million in the U.S., as per IQVIA data from July 2024[1].

Financial Performance of Branded Nizoral

Alliance Pharma, the company behind the branded version of Nizoral, has seen significant financial performance from this product. In the second half of 2022, Nizoral revenues recovered strongly, growing 15% on a constant exchange rate (CER) basis, partly due to delayed orders from the first half falling into the second half and the completion of marketing authorisation transfers in China and Vietnam[5].

Revenue and Profitability

For the year 2022, Nizoral revenues contributed to Alliance Pharma's total consumer healthcare revenues, which were £125.2 million, up 3% on the prior year. The company expects high single-digit revenue growth for Nizoral in 2023, supported by new marketing initiatives and updated packaging[5].

Impact of Generic Competition

The entry of generic versions of ketoconazole can impact the financial performance of the branded product. Generic drug pricing is often competitive, which could lead to reduced market share and revenue for the branded Nizoral. However, Alliance Pharma's diversified portfolio and ongoing marketing efforts are expected to mitigate some of this impact[5].

Distribution and Marketing Strategies

Effective distribution and marketing strategies will be crucial for both branded and generic versions of ketoconazole. ANI Pharmaceuticals' ability to capture market share will depend on its manufacturing efficiency, distribution strategy, and competitive pricing[1].

Global Market Trends

The global market for ketoconazole is influenced by various trends, including the growing demand for over-the-counter antifungal medications and the expansion of the pharmaceutical sector. These trends are expected to continue driving the market growth over the next several years[4].

Regional Performance

Regional performance varies, with strong growth seen in certain markets. For example, Nizoral revenues in China and Vietnam have been boosted by the completion of marketing authorisation transfers and the appointment of new distributors[5].

Financial Trajectory

The financial trajectory for Nizoral and its generic counterparts is promising, given the projected market growth. Here are some key financial highlights:

• Market Size: The global ketoconazole market is expected to reach USD 1.2 billion by 2031[4].
• Revenue Growth: Nizoral revenues have shown strong recovery and growth, with expectations of high single-digit growth in 2023[5].
• Competitive Impact: The entry of generic versions could impact the branded product's revenue, but a diversified portfolio and strong marketing efforts can help maintain market share[5].

Key Takeaways

• The ketoconazole market, including Nizoral, is expected to grow significantly, driven by increasing fungal infections, growing awareness, and the expansion of the pharmaceutical sector.
• Generic competition, such as ANI Pharmaceuticals' Ketoconazole Shampoo, 2%, is entering the market, potentially impacting the branded product's revenue.
• Effective distribution and marketing strategies are crucial for maintaining market share.
• The global market trends and regional performance indicate a strong financial trajectory for ketoconazole-based treatments.

FAQs

What is the projected market size for ketoconazole by 2031?

The global ketoconazole market is expected to reach USD 1.2 billion by 2031, growing at a CAGR of 4.6% from 2024 to 2031[4].

How does the entry of generic versions impact the branded Nizoral?

The entry of generic versions can lead to reduced market share and revenue for the branded Nizoral due to competitive pricing, but a diversified portfolio and strong marketing efforts can help mitigate this impact[1][5].

What are the key drivers of the ketoconazole market growth?

The key drivers include the increasing prevalence of fungal infections, growing awareness and accessibility of antifungal medications, expansion of the pharmaceutical sector, and the rising prevalence of skin diseases such as seborrheic dermatitis and dandruff[4].

How has Nizoral performed financially in recent years?

Nizoral revenues have shown strong recovery and growth, with a 15% increase on a CER basis in the second half of 2022. The company expects high single-digit revenue growth for Nizoral in 2023[5].

What role do distribution and marketing strategies play in the market?

Effective distribution and marketing strategies are crucial for capturing and maintaining market share, especially in a competitive market with both branded and generic versions of ketoconazole[1][5].

Sources

1. ANI Pharmaceuticals Announces the FDA Approval and Launch of Ketoconazole Shampoo, 2% - Stock Titan
2. 2023 Annual Report - Alliance Pharma
3. Generic KETOCONAZOLE INN equivalents - Drug Patent Watch
4. Ketoconazole Market Size, Share and Forecast to 2031 - Market Research Intellect
5. Alliance Pharma plc 2022 FY Trading Update - Alliance Pharma