CLASCOTERONE - Generic Drug Details

What are the generic sources for clascoterone and what is the scope of patent protection?

Clascoterone is the generic ingredient in one branded drug marketed by Sun Pharm and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Clascoterone has eighty-nine patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for CLASCOTERONE

International Patents:	89
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	4
Patent Applications:	145
What excipients (inactive ingredients) are in CLASCOTERONE?	CLASCOTERONE excipients list
DailyMed Link:	CLASCOTERONE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CLASCOTERONE

Dosage:

CREAM;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CLASCOTERONE

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

Sponsor	Phase
Chang Gung Memorial Hospital	Phase 1/Phase 2
ICON Clinical Research	Phase 3
Stanford University	Phase 1/Phase 2

See all CLASCOTERONE clinical trials

Pharmacology for CLASCOTERONE

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for CLASCOTERONE

D10AX	Other anti-acne preparations for topical use
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for CLASCOTERONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
WINLEVI	Cream	clascoterone	1%	213433	1	2024-08-26

US Patents and Regulatory Information for CLASCOTERONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes			Y
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes			Y

International Patents for CLASCOTERONE

Country	Patent Number	Title	Estimated Expiration
China	103450304	Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Russian Federation	2482190
Canada	2871039	PROCEDE ENZYMATIQUE POUR OBTENIR DES 17 ALPHA-MONOESTERS DE CORTEXOLONE ET/OU SES DERIVES 9,11-DESHYDRO (ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES)

CLASCOTERONE Market Analysis and Financial Projection Experimental

The Rising Star of Dermatology: Understanding the Market Dynamics and Financial Trajectory of Clascoterone

Introduction

Clascoterone, a novel selective androgen receptor inhibitor (SARI), is revolutionizing the dermatology sector, particularly in the treatment of acne and other androgen-related skin conditions. This article delves into the market dynamics, financial trajectory, and the factors driving the growth of the clascoterone market.

The Growing Importance of Clascoterone in Pharma

Clascoterone is gaining significant importance in the pharmaceutical industry due to its innovative approach and potential benefits over traditional treatments. As a topical treatment, it reduces systemic exposure and related side effects, offering a targeted therapy by specifically addressing androgen activity in the skin[1].

Transformative Potential in Acne Treatment

Reduced Side Effects

Unlike traditional acne treatments such as antibiotics, retinoids, and hormonal therapies, clascoterone minimizes systemic side effects due to its topical application. This localized treatment approach reduces broader hormonal impacts, making it a safer option for patients[1].

Targeted Therapy

Clascoterone's mechanism of action involves inhibiting androgen receptors in the skin, providing a focused treatment for acne. Clinical trials have shown promising results, with clascoterone demonstrating efficacy in reducing acne lesions and improving skin appearance[1].

Market Growth and Investment Opportunities

Increased Prevalence of Acne

The rising prevalence of acne among both adolescents and adults is a key driver of the clascoterone market. Acne remains one of the most common dermatological conditions, driving demand for effective and safe treatments[1][3].

Rising Awareness and Acceptance

Growing awareness of the benefits of targeted therapies is enhancing market acceptance. Patients and healthcare providers are increasingly seeking treatments that are both effective and gentle on the skin, further boosting the demand for clascoterone[3].

Investment and Innovation

Pharmaceutical companies are investing heavily in clascoterone research and development. This investment is creating opportunities for breakthroughs and market expansion, with companies like Glenmark Pharmaceuticals and Cassiopea SpA at the forefront of these efforts[1][5].

Recent Trends and Developments

Advances in Research and Development

Ongoing research is exploring the full potential of clascoterone beyond acne treatment. Studies are investigating its effectiveness for other androgen-related conditions, such as androgenetic alopecia and hormonal therapy, potentially broadening its application in dermatology[1][3].

Strategic Partnerships and Collaborations

Pharmaceutical companies are forming strategic partnerships to advance clascoterone’s development and commercialization. For example, Sun Pharma and Cassiopea have entered into exclusive license and supply agreements for Winlevi (clascoterone cream 1%), facilitating its commercialization in the United States and Canada[5].

Regulatory Approvals and Market Launches

Recent regulatory approvals for clascoterone-based products have paved the way for their market introduction. Successful launches in key regions, such as the agreements between Glenmark and Cosmo Pharmaceuticals for the distribution of Winlevi in European countries, the UK, and South Africa, are expected to drive market growth[2][5].

Market Size and Projections

The clascoterone market is valued at USD 5.3 billion as of 2023 and is projected to reach USD 10 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.1% from 2024 to 2031. This growth is driven by the increasing use of clascoterone in dermatology, particularly in acne treatment, and its potential applications in other androgen-related conditions[3].

Financial Performance and Investment

Revenue Growth

Companies involved in the development and commercialization of clascoterone are experiencing significant revenue growth. For instance, Glenmark Pharmaceuticals reported a consolidated revenue growth of 6.9% in the first quarter of FY 2024-25, with their dermatology segment contributing substantially to this growth[2].

EBITDA and PAT Margins

Glenmark’s financial performance indicates strong operational efficiency, with an EBITDA margin of 18.1% and a PAT margin of 10.5% in the first quarter of FY 2024-25. This financial health underscores the company’s ability to invest in research and development, including clascoterone[2].

Strategic Alliances

The financial trajectory of the clascoterone market is also influenced by strategic alliances. For example, the partnership between Glenmark and Cosmo Pharmaceuticals for the distribution of Winlevi in Europe and other regions is expected to enhance revenue through expanded market reach[2].

Consumer and Market Demand

Increasing Demand for Skincare Products

The demand for clascoterone is expanding due to the growing preference of patients for skincare products that are both gentle and effective. The increasing prevalence of acne and other skin conditions, coupled with rising consumer awareness of skincare and cosmetic issues, is driving the market forward[3].

Expert Endorsements and Regulatory Approval

Clascoterone's safety and effectiveness are confirmed by expert healthcare endorsements and regulatory approvals. This validation further boosts market confidence and consumer trust, contributing to the drug's financial success[1][3].

Future Prospects and Potential Beyond Acne

Broader Applications in Dermatology

Ongoing research is investigating clascoterone’s potential for treating other androgen-related dermatological conditions. This could significantly expand its use and increase its impact in the broader field of dermatology, opening up new market opportunities[1][3].

Solid Tumors and Other Conditions

Clascoterone is also under development for the treatment of solid tumors, including androgen-independent prostate adenocarcinoma, further diversifying its potential applications and market reach[4].

Key Takeaways

• Innovative Treatment Approach: Clascoterone offers a targeted and safer treatment option for acne and other androgen-related skin conditions.
• Market Growth: The clascoterone market is projected to grow significantly, driven by increasing acne prevalence, rising awareness of targeted therapies, and substantial investment in research and development.
• Financial Performance: Companies involved in clascoterone development are experiencing strong revenue growth and healthy financial margins.
• Strategic Partnerships: Collaborations between pharmaceutical companies are crucial for advancing clascoterone’s development and commercialization.
• Future Prospects: Clascoterone has potential applications beyond acne, including other dermatological conditions and solid tumors.

FAQs

1. What is clascoterone and how does it work?

Clascoterone is a selective androgen receptor inhibitor (SARI) used in topical treatments to target androgen receptors in the skin, helping manage acne by reducing androgen activity[1].

2. What are the benefits of clascoterone over traditional acne treatments?

Clascoterone offers targeted action with fewer systemic side effects compared to traditional treatments, ensuring localized treatment and minimizing broader hormonal impacts[1].

3. How is the clascoterone market expected to grow?

The clascoterone market is projected to grow significantly due to increasing acne prevalence, rising acceptance of targeted therapies, and substantial investment in research and development, with a CAGR of 8.1% from 2024 to 2031[3].

4. What recent trends are influencing the clascoterone market?

Recent trends include advancements in research exploring clascoterone’s applications beyond acne, strategic partnerships between pharmaceutical companies, and new regulatory approvals facilitating market entry and expansion[1][3].

5. What potential does clascoterone have beyond acne treatment?

Ongoing research is investigating clascoterone’s potential for treating other androgen-related dermatological conditions and solid tumors, which could expand its use and increase its impact in the broader field of dermatology[1][3].

Sources

1. Market Research Intellect - Pharma's Rising Star: Clascoterone Market Poised for Transformative Impact.
2. Glenmark Pharmaceuticals - Glenmark Pharma reports consolidated revenue growth of 6.9%, EBITDA margin of 18.1%, and PAT margin of 10.5% YoY for Q1 FY 2024-25.
3. Market Research Intellect - Clascoterone Market Size and Projections.
4. GlobalData - Clascoterone (CB-0301, Winlevi).
5. PR Newswire - Sun Pharma and Cassiopea announce the expiry of the HSR Act process and the successful consummation of their Winlevi (clascoterone cream 1%) agreement.