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Last Updated: December 22, 2024

KETOZOLE Drug Patent Profile


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When do Ketozole patents expire, and what generic alternatives are available?

Ketozole is a drug marketed by Taro and is included in one NDA.

The generic ingredient in KETOZOLE 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 Ketozole

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

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Drug patent expirations by year for KETOZOLE

US Patents and Regulatory Information for KETOZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Taro KETOZOLE ketoconazole CREAM;TOPICAL 075638-001 Dec 18, 2002 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for KETOZOLE

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

KETOZOLE Market Analysis and Financial Projection Experimental

Ketoconazole Market Dynamics and Financial Trajectory

Introduction

Ketoconazole, an antifungal medication, has been a staple in the pharmaceutical industry for decades, treating a variety of conditions including fungal infections and hair loss. Here, we delve into the market dynamics and financial trajectory of ketoconazole, highlighting key trends, drivers, and players in the industry.

Market Growth and CAGR

The ketoconazole market is anticipated to grow at a strong Compound Annual Growth Rate (CAGR) of approximately 3.1% during the forecast period from 2023 to 2030. This growth is driven by several factors, including the increasing demand for skincare and antifungal drugs globally, rising research and development activities, and the expanding urban population[1][4].

Key Drivers

Rising Demand for Skincare and Antifungal Drugs

The global demand for skincare products, particularly those with antifungal properties, is on the rise. This is partly due to increasing awareness about health and skincare, as well as the growing urban population. Ketoconazole, with its efficacy in treating fungal infections and hair loss, is a significant beneficiary of this trend[1][4].

Product Launches and Innovations

Pharmaceutical companies are continuously launching new and innovative products, which is a major driver for the ketoconazole market. For instance, ANI Pharmaceuticals recently received FDA approval and launched a generic version of Nizoral® (ketoconazole shampoo), entering a market with annual sales of approximately $69.2 million in the USA[3].

Strategic Collaborations and Acquisitions

The market is also driven by strategic partnerships and acquisitions. For example, Alliance partnered with Alniche to market Nizral & Nizoral (ketoconazole) in India, highlighting the importance of collaborations in expanding market reach[1].

Market Segmentation

By Product Type

The ketoconazole market is segmented into oral, topical, and shampoo forms. The oral category is expected to grow with a high CAGR during the forecast period, while the shampoo segment, particularly for hair loss treatment, is also gaining prominence[4].

By Application

The market is segmented into antifungal, hair loss, and other applications. The antifungal segment dominated the market in 2022 due to the surge in compromised immune systems and the adaptation of harmful pathogens to warmer temperatures. The hair loss segment is expected to grow significantly due to rising cases of hair loss and the demand for safe and effective haircare medicines[1][4].

Regional Analysis

North America

North America dominated the ketoconazole market in 2022, driven by factors such as the availability of innovative products, growing health awareness, and significant investments in product discovery. The region continues to be a key market due to its large urban population and advanced healthcare infrastructure[1].

Asia-Pacific

The Asia-Pacific region is expected to grow with the highest CAGR during the forecast period. This growth is attributed to the increasing number of ketoconazole manufacturing companies in the region, along with rising demand for skincare products and antifungal drugs due to lifestyle changes and urbanization[4].

Major Players

The ketoconazole market is competitive, with several major players operating globally. These include Mylan Inc., Almirall, S.A, Johnson & Johnson Services, Inc., Taro Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., Sandoz Group AG, Strides Pharma Science Limited, LGM Pharma, AKSHAR PHARMA, and Gonane Pharma[1][4].

Financial Trajectory

Revenue and Market Size

The global ketoconazole market was valued at approximately $106.24 million in 2022 and is expected to grow significantly over the forecast period. The launch of new products, such as ANI Pharmaceuticals' generic ketoconazole shampoo, is expected to contribute substantially to this growth, with the U.S. market for ketoconazole shampoo alone valued at around $69.2 million annually[3][4].

Profit Margins and Competitive Landscape

While the market size is significant, the actual profit margins will depend on factors such as manufacturing efficiency, distribution strategies, and the ability to capture market share from branded products. Generic drug pricing can be highly competitive, making these factors crucial for determining the financial impact of new product launches[3].

Recent Developments and Launches

FDA Approvals

Recent FDA approvals, such as the approval of ANI Pharmaceuticals' generic ketoconazole shampoo, highlight the ongoing innovation in the market. These approvals not only expand the product portfolio of companies but also address patient needs more effectively[3].

Strategic Moves

Companies are making strategic moves to enhance their market presence. For example, the launch of ketoconazole shampoo by ANI Pharmaceuticals aligns with the company's strategic priority to launch new products that meet patient needs, potentially boosting revenue and market share[3].

Challenges and Opportunities

Competitive Pricing

One of the challenges in the ketoconazole market is competitive pricing, especially for generic versions. Companies need to balance pricing with manufacturing efficiency and distribution strategies to maintain profitability[3].

Growing Demand

The growing demand for antifungal and hair loss treatments presents a significant opportunity for companies to innovate and expand their product lines. This demand is driven by increasing health awareness and the need for safe and effective treatments[1][4].

Key Takeaways

  • The ketoconazole market is expected to grow at a CAGR of 3.1% from 2023 to 2030.
  • The market is driven by rising demand for skincare and antifungal drugs, product launches, and strategic collaborations.
  • North America and Asia-Pacific are key regions, with the latter expected to grow at the highest CAGR.
  • Major players include Mylan Inc., Almirall, S.A, and Johnson & Johnson Services, Inc.
  • Recent FDA approvals and product launches are significant for market growth.
  • Competitive pricing and manufacturing efficiency are crucial for profitability.

FAQs

Q1: What is the expected CAGR of the ketoconazole market from 2023 to 2030?

The ketoconazole market is expected to grow at a CAGR of approximately 3.1% during the forecast period from 2023 to 2030[1][4].

Q2: Which region dominated the ketoconazole market in 2022?

North America dominated the ketoconazole market in 2022, driven by factors such as the availability of innovative products and growing health awareness[1].

Q3: What is the significance of the recent FDA approval of ANI Pharmaceuticals' generic ketoconazole shampoo?

The FDA approval of ANI Pharmaceuticals' generic ketoconazole shampoo marks a significant entry into a market with annual sales of approximately $69.2 million in the USA, aligning with the company's strategic priority to launch new products that meet patient needs[3].

Q4: Which segment is expected to grow with the highest CAGR in the ketoconazole market?

The hair loss segment is expected to grow with a high CAGR due to rising cases of hair loss and the increasing demand for safe and effective haircare medicines[1].

Q5: What are the key challenges faced by companies in the ketoconazole market?

Companies face challenges such as competitive pricing, especially for generic versions, and the need to balance pricing with manufacturing efficiency and distribution strategies to maintain profitability[3].

Sources

  1. Ketoconazole Market: Current Analysis and Forecast (2023-2030) - GIIR Research
  2. Optinose Reports Second Quarter 2024 Financial Results and Recent Operational Highlights - Optinose
  3. ANI Pharmaceuticals Announces the FDA Approval and Launch of Ketoconazole Shampoo, 2% - Stock Titan
  4. Ketoconazole Market : Share, Size, Trends, Growth & Forecast to 2030 - UnivDatos
  5. Cumberland Pharmaceuticals Reports 16% Sequential Revenue Growth in Second Quarter 2024 - Cumberland Pharmaceuticals

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