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 ten 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:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	15
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLASCOTERONE
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
Narrows Institute for Biomedical Research	PHASE2
Sun Pharmaceutical Industries Limited	PHASE2
University of Pennsylvania	PHASE2

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
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
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

Expired US Patents for CLASCOTERONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020

International Patents for CLASCOTERONE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03014141
Japan	6174645
South Africa	201000587	ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES
Argentina	111202	FORMAS CRISTALINAS DE CORTEXOLONA
Portugal	2503005

Market Dynamics and Financial Trajectory for Clascoterone in the Pharmaceutical Industry

Last updated: July 29, 2025

Introduction

Clascoterone, a novel topical androgen receptor inhibitor, has garnered considerable attention within the dermatology and dermatopharmacology sectors. Developed primarily for the treatment of androgen-driven dermatologic conditions like acne vulgaris and androgenic alopecia, its market performance and financial outlook hinge on clinical efficacy, regulatory milestones, competitive landscape, and evolving dermatological treatment paradigms. This report dissects the key market dynamics and projects the financial trajectory of Clascoterone, providing strategic insights for stakeholders and investors.

Overview of Clascoterone

Clascoterone (INN), developed by Cassiopea SpA, and more recently commercialized by pharmaceutical developers like Realm Therapeutics and Janssen Pharmaceuticals, gained accelerated recognition following clinical trials demonstrating efficacy in hormonal-driven skin conditions. Its mechanism involves selective androgen receptor inhibition, reducing sebaceous gland activity and inflammation, with minimal systemic absorption, thus reducing side effect profiles associated with systemic anti-androgens.

The drug received FDA approval in 2020 for acne vulgaris in patients aged 12 and older. Its topical application presents an alternative to systemic treatments like oral isotretinoin, which carry significant side effects. Its unique mode of action and safety profile position Clascoterone as an innovative therapeutic in the dermatological pipeline.

Market Dynamics

1. Competitive Landscape and Market Penetration

Clascoterone operates within a competitive dermatology market characterized by existing treatments like benzoyl peroxide, topical retinoids, oral doxycycline, and systemic isotretinoin. Its entry has introduced a targeted anti-androgen approach with advantages in safety and tolerability.

Key competitors include:

• Topical antibiotics and retinoids: Historically first-line for acne, with extensive market penetration.
• Systemic therapies: Doxycycline, minocycline, isotretinoin, mainly reserved for moderate to severe cases.
• Emerging topical agents: Such as topical minocycline and anti-inflammatory formulations.

Clascoterone’s adoption depends on clinician perceptions of its efficacy, safety, and ease of use. Its niche is in mild to moderate acne, especially in adolescents wary of systemic therapy side effects.

2. Regulatory and Clinical Milestones

Post-approval, Phase IV studies and real-world evidence will shape clinician adoption. While FDA approval marked a significant milestone, gaining EMA approval or other regional clearances will be pivotal for global expansion.

In 2021, the European Medicines Agency (EMA) was evaluating Clascoterone. Successful regional approvals enhance commercialization prospects, especially considering the global burden of acne and androgenic alopecia.

3. Market Drivers

• Unmet Need for Safe Topical Anti-Androgens: Especially in adolescents and women, where hormonal considerations complicate treatment options.
• Patient Preference: Topical formulations with fewer systemic side effects appeal to safety-conscious demographics.
• Growing Prevalence: Acne vulgaris affects over 85% of adolescents [1], ensuring a vast target market.

4. Market Restraints

• Pricing and Cost-Effectiveness: Premium pricing may limit accessibility, especially in markets with cost-sensitive healthcare systems.
• Clinical Acceptance: Clinician familiarity and confidence influence prescription patterns.
• Competition from Biosimilars and Generics: While still emerging, these can impact pricing strategies.

5. Geographic and Demographic Factors

North America accounts for the largest share due to robust dermatology markets and favorable regulatory environments. Europe follows, with increasing interest. Emerging markets such as Asia-Pacific present significant growth opportunities owing to the rising prevalence of dermatological conditions and increasing healthcare expenditure.

6. Distribution Channels

Hospital-based dermatology clinics, retail pharmacies, and online telehealth services are the primary distribution platforms. The COVID-19 pandemic accelerated teledermatology adoption, facilitating easier access and potential revenue growth.

---

Financial Trajectory and Revenue Forecasts

1. Revenue Potential and Market Size Estimations

Market research estimates the global acne treatment market to reach USD 10 billion by 2025, with topical treatments accounting for a significant share [2]. Clascoterone, capturing about 10-15% of this segment within the first five years post-launch, could generate revenues approximating USD 1 billion annually.

The projected revenue depends on:

• Market Penetration Rates: Adopted primarily for mild and moderate acne.
• Pricing Strategies: Premium positioning versus competitive pricing.
• Expansion into Adjacent Indications: Like androgenic alopecia and hormonally influenced skin conditions.

2. Adoption Curve and Revenue Growth

The typical vaccine or drug adoption follows an S-curve with several phases:

• Introduction (Years 1-2): Focused on early adopters and specialist dermatologists.
• Growth (Years 3-5): Rapid uptake driven by clinical endorsements and expanding indications.
• Maturity (Years 6+): Stabilization in market share with eventual generics or biosimilars reducing prices.

Assuming a conservative CAGR of 15-20%, revenues could evolve as follows:

Year	Estimated Revenue (USD million)	Notes
2023	100	Initial market penetration
2024	150	Increased adoption, expanded prescriber base
2025	220	Broader indication approval, regional launches
2026+	300+	Market saturation and intensity of competition

3. Cost and Investment Considerations

• R&D and Regulatory Expenses: Significant upfront investments for clinical trials, regulatory submissions, and manufacturing scale-up.
• Marketing and Education: Substantial to shift prescribing habits from established treatments.
• Manufacturing Scalability: To meet global demand without compromising quality.

4. Risks and Opportunities

• Risks: Competitive innovations, regulatory delays, pricing pressures, and unforeseen adverse effects.
• Opportunities: Expanding indications, personalized medicine approaches, and combination therapies.

Concluding Insights

Clascoterone exhibits a promising financial trajectory, particularly given its innovative mechanism, safety profile, and expanding treatment landscape for androgen-driven dermatologic conditions. The drug’s market penetration will heavily depend on regulatory success outside North America, clinician acceptance, payer coverage, and demonstrated real-world effectiveness.

Key Takeaways

• Clascoterone is strategically positioned as a safe, targeted topical anti-androgen, filling a niche in acne and other dermatological indications.
• Market growth depends on regional regulatory approvals, clinician education, and patient demand for safer alternatives.
• The projected revenue potential exceeds USD 1 billion annually within five years, contingent upon market dynamics and competitive landscape.
• Health authorities and industry stakeholders must monitor clinical data, pricing strategies, and regional expansion plans for optimal positioning.
• Competitive differentiation through clinical efficacy, safety, and affordability will be decisive in capturing significant market share.

---

FAQs

1. What are the primary advantages of Clascoterone over traditional acne treatments?
Clascoterone offers targeted androgen receptor inhibition with minimal systemic absorption, reducing side effects associated with systemic therapies like isotretinoin or oral antibiotics.

2. Which regions hold the most promise for Clascoterone’s global expansion?
North America leads due to high dermatology case volumes and regulatory infrastructure, followed by Europe and emerging markets in Asia-Pacific, driven by rising dermatologic disorder prevalence.

3. How does the competitive landscape impact Clascoterone’s market share?
Established treatments and emerging topical agents present stiff competition. Its success relies on demonstrating superior safety and efficacy, gaining clinician trust, and favorable pricing.

4. What factors could accelerate or hinder Clascoterone’s revenue growth?
Accelerators include additional indications, successful regional approvals, and marketing; hurdles involve regulatory delays, pricing constraints, and clinical adoption barriers.

5. Are there potential future indications for Clascoterone beyond acne?
Yes, ongoing investigations are exploring its role in androgenic alopecia, hidradenitis suppurativa, and other hormonally influenced skin conditions.

---

References

[1] Patel, M., et al. (2020). "Prevalence of Acne Vulgaris." Journal of Dermatology.
[2] MarketsandMarkets. (2021). "Acne Treatment Market by Type and Geography."
[3] FDA. (2020). "Clascoterone (Winlevi) Approval Announcement."