NIZORAL ANTI-DANDRUFF Drug Patent Profile

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

Nizoral Anti-dandruff is a drug marketed by Kramer and is included in one NDA.

The generic ingredient in NIZORAL ANTI-DANDRUFF 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 Anti-dandruff

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

Summary for NIZORAL ANTI-DANDRUFF

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Patent Applications:	1,512
DailyMed Link:	NIZORAL ANTI-DANDRUFF at DailyMed

Pharmacology for NIZORAL ANTI-DANDRUFF

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

US Patents and Regulatory Information for NIZORAL ANTI-DANDRUFF

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

Expired US Patents for NIZORAL ANTI-DANDRUFF

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
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997	5,456,851
Kramer	NIZORAL ANTI-DANDRUFF	ketoconazole	SHAMPOO;TOPICAL	020310-001	Oct 10, 1997	4,942,162

EU/EMA Drug Approvals for NIZORAL ANTI-DANDRUFF

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 ANTI-DANDRUFF

See the table below for patents covering NIZORAL ANTI-DANDRUFF around the world.

Country	Patent Number	Title	Estimated Expiration
Finland	63398
China	1149250
Denmark	0758879
Spain	465981
Australia	521329
Greece	62553	NOVEL 1-(1,3-DIOXALAN-2-YLMETHYL)-1H-IMIDAZOLES AND 1H-1,2,4-TRIAZOLES

NIZORAL ANTI-DANDRUFF Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NIZORAL Anti-Dandruff Shampoo

Introduction to NIZORAL Anti-Dandruff Shampoo

NIZORAL, a brand well-known for its anti-dandruff shampoo, contains the active ingredient ketoconazole. This medication is widely used for treating various fungal infections, including those causing dandruff and seborrheic dermatitis.

Market Size and Growth

The ketoconazole market, which includes NIZORAL, is projected to experience significant growth. As of 2023, the ketoconazole market was valued at USD 782.3 million and is expected to reach USD 1.2 billion by 2031, growing at a CAGR of 4.6% from 2024 to 2031[3][4].

Regional Dominance

The Asia-Pacific (APAC) region is a key driver of this growth. The APAC region is expected to grow with the highest CAGR during the forecast period due to the increasing number of ketoconazole manufacturing companies and the rising demand for skincare products in this region. This demand is fueled by the large population and changing lifestyles in APAC[1][3].

Acquisition and Market Expansion

A significant event in the market dynamics of NIZORAL was the acquisition of its marketing rights in the APAC region by Alliance Pharma. In 2018, Alliance Pharma acquired the exclusive marketing rights to NIZORAL from Janssen Pharmaceutica NV for £60 million. This acquisition included rights in over 15 countries, including Japan, Thailand, South Korea, China, and other Pacific markets. This move was expected to enhance Alliance's exposure to the fast-growing APAC markets and generate material earnings enhancement[2].

Market Segmentation

The ketoconazole market is segmented based on application, with the antifungal segment holding a significant share. This is due to the increasing prevalence of fungal infections and the effectiveness of ketoconazole in treating these conditions. NIZORAL, as an anti-dandruff shampoo, falls under this segment and benefits from the growing demand for antifungal medications[1][3].

Competitive Landscape

The market for ketoconazole, including NIZORAL, is competitive with both branded and generic products. However, NIZORAL's strong brand presence and medical heritage, particularly in the APAC region, position it favorably. Companies are implementing various strategies such as new product launches, expansions, mergers and acquisitions, and partnerships to strengthen their market position[2][4].

Financial Trajectory

The financial trajectory of NIZORAL is promising, driven by the growing demand for antifungal medications and the expanding pharmaceutical sector. In 2017, the NIZORAL rights in APAC generated net sales of £18.5 million and a pro forma EBITDA of £7.1 million. The acquisition by Alliance Pharma was funded by a combination of equity placing and debt, indicating a strong financial commitment to the brand's growth[2].

Revenue and Profit Margins

The launch of new products and the expansion into new markets are 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. Manufacturing efficiency and distribution strategies will be crucial in determining profit margins[4].

Regulatory Approvals

Regulatory approvals are critical for the market entry and growth of NIZORAL. Companies must navigate regulatory landscapes to ensure timely and successful product launches. For instance, FDA approvals for new formulations or products can significantly impact the market trajectory[4].

Technological and R&D Trends

The ketoconazole market, including NIZORAL, is witnessing advances in formulations and emerging technologies. Companies are investing in research and development to create more effective and safer antifungal agents. These advancements are expected to enhance the efficacy and safety of ketoconazole products, further driving market growth[4].

Dandruff Treatment Market Context

In the broader context of the dandruff treatment market, ketoconazole shampoos, such as NIZORAL, hold a dominant market position. As of 2023, ketoconazole shampoos captured more than a 30% share of the treatment segment in the dandruff treatment market, which was valued at USD 9.3 billion and is expected to reach USD 17.2 billion by 2033 at a CAGR of 6.5%[5].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as 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. Regulatory approvals and technological advancements are also crucial for navigating these challenges and capitalizing on opportunities[4].

Key Takeaways

• The ketoconazole market, including NIZORAL, is expected to grow significantly, reaching USD 1.2 billion by 2031.
• The APAC region is a key growth driver due to increasing demand for skincare products and the presence of ketoconazole manufacturing companies.
• NIZORAL's acquisition by Alliance Pharma has enhanced its market presence in APAC.
• The market is driven by the growing prevalence of fungal infections and the expanding pharmaceutical sector.
• Regulatory approvals and technological advancements are critical for market growth.
• Ketoconazole shampoos, such as NIZORAL, dominate the dandruff treatment market segment.

FAQs

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

The ketoconazole market was valued at USD 782.3 million in 2023[3].

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[3].

Q3: Which region is expected to grow with the highest CAGR in the ketoconazole market?

The Asia-Pacific (APAC) region is expected to grow with the highest CAGR during the forecast period[1][3].

Q4: What was the significance of Alliance Pharma's acquisition of NIZORAL rights in APAC?

Alliance Pharma acquired the exclusive marketing rights to NIZORAL in APAC for £60 million, enhancing its exposure to the fast-growing APAC markets and generating material earnings enhancement[2].

Q5: What is the market share of ketoconazole shampoos in the dandruff treatment market?

Ketoconazole shampoos, such as NIZORAL, hold a dominant market position with more than a 30% share of the treatment segment in the dandruff treatment market[5].

Sources:

1. UnivDatos, Ketoconazole Market : Share, Size, Trends, Growth & Forecast to 2030.
2. Alliance Pharma, Nizoral Acquisition in APAC and Proposed Placing.
3. Market Research Intellect, Global Ketoconazole Market Size, Share and Forecast to 2031.
4. Drug Patent Watch, Generic KETOCONAZOLE INN equivalents, pharmaceutical patent ....
5. Market Research Biz, Dandruff Treatment Market Size, Share, Growth | CAGR of 6.5%.