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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Clascoterone has ninety-three patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for CLASCOTERONE

International Patents:	93
US Patents:	8
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			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
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
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes			Y

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
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020

International Patents for CLASCOTERONE

Country	Patent Number	Title	Estimated Expiration
Hungary	E044237
Poland	2173891
Denmark	2503005
Mexico	2019003639	PROCESO ENZIMATICO PARA OBTENER 17 ALFA-MONOESTERES DE CORTEXOLONA Y/O SUS 9,11-DEHIDRODERIVADOS. (ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES.)
Japan	2010535173
China	104861023	Enzymatic Process For Obtaining 17 Alpha-monoesters Of Cortexolone And/or Its 9,11-dehydroderivatives
Croatia	P20151174

Supplementary Protection Certificates for CLASCOTERONE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2503005	C20250037	Finland
2503005	2025C/551	Belgium		PRODUCT NAME: CLASCOTERON EN KRISTALLIJNE VORMEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/25/1927 20251021
2503005	CR 2025 00047	Denmark		PRODUCT NAME: CLASCOTERONE AND CRYSTALLINE FORMS THEREOF; REG. NO/DATE: EU/1/25/1927 20251017
2503005	CA 2025 00047	Denmark		PRODUCT NAME: CLASCOTERONE AND CRYSTALLINE FORMS THEREOF; REG. NO/DATE: EU/1/25/1927 20251017
2503005	301358	Netherlands		PRODUCT NAME: CLASCOTERON EN KRISTALLIJNE VORMEN DAARVAN; REGISTRATION NO/DATE: EU/1/25/1927 20251021

Market Dynamics and Financial Trajectory for Clascoterone

Last updated: March 12, 2026

What is Clascoterone and its current market position?

Clascoterone is a topical androgen receptor inhibitor approved by the U.S. Food and Drug Administration (FDA) in August 2020 for the treatment of acne vulgaris in patients aged 12 years and older. Manufactured by Cassiopea SpA, a company acquired by Pfizer in 2021, Clascoterone marks a novel approach for androgen-based dermatological therapies. Its unique mechanism targets localized androgen activity, reducing systemic side effects common with oral treatments.

What are the key market drivers for Clascoterone?

Growing acne prevalence

Acne affects approximately 85% of adolescents and 15% of adults globally. The increasing incidence, combined with unmet needs for safe, effective treatments, creates a sustained demand. According to the World Health Organization (WHO), acne accounts for a significant share of dermatology outpatient visits.

Shift toward targeted topical therapies

Clinicians favor topical over systemic treatments to minimize side effects. Clascoterone offers a localized approach, appealing to both patients and healthcare providers seeking safer management options.

Competitive landscape and differentiation

Existing treatments include oral isotretinoin and topical retinoids, which carry systemic risks and tolerability issues. Clascoterone’s favorable safety profile positions it as a differentiated product in a crowded market.

Expansion potential into other indications

Research explores Clascoterone for androgenetic alopecia and hidradenitis suppurativa, which could expand its market footprint.

How does the regulatory status influence market dynamics?

FDA approval timeline and scope

Clascoterone received FDA approval for acne in August 2020. It is marketed as Winlevi by Cassiopea/Pfizer. It holds additional approval in the European Union, with filing activities ongoing in other regions.

Patent protection

Patent rights extend into the late 2030s, offering exclusivity that sustains pricing power and deters generic competition in the near term.

Regulatory hurdles

Future approvals depend on subsequent clinical trials for off-label uses. Regulatory delays or rejections would impact market penetration and revenue projections.

What are the market forecasts and revenue projections?

Short-term outlook (2023-2025)

Market analysts project Clascoterone sales of approximately $100 million in 2023, driven by initial adoption and expanded prescribing guidelines. Growth rates are expected at approximately 20-25% annually, contingent upon increase in prescriptions and geographic expansion.

Mid-term outlook (2026-2030)

Sales could surpass $500 million worldwide, especially if approvals for other indications occur. Increasing awareness, formulary inclusion, and positive clinician reports will support growth. Competition from established treatments will influence the trajectory.

Key growth factors

• Pharmaceutical partnerships and marketing strategies
• Insurance coverage and reimbursement policies
• Clinical trial results supporting additional indications
• Geographic expansion into emerging markets

Risks impacting revenue

• Regulatory delays or denials
• Market saturation in key regions
• Competition from newer or generic therapies
• Pricing pressures and healthcare policy changes

What are the competitive products and their impact?

Product	Market Share (2022)	Approval Status	Notes
Differin (adapalene)	30%	FDA approved since 2016	Widely used retinoid, limited anti-androgen activity
Epiduo (adapalene + benzoyl peroxide)	25%	Long-standing market presence	Combines retinoid and antibacterial action
Topical Minocycline	Approx. 10%	Approved in some countries	Antibiotic-based topical, resistance concerns
Winlevi (clascoterone)	New entrant	Approved 2020, niche market	Differentiates with anti-androgen mechanism

Clascoterone’s main competitor is topical retinoids; however, its anti-androgen properties may appeal to patients with hormonally driven acne or sensitive skin intolerance to retinoids.

How does pricing influence financial trajectory?

Pricing strategy

Clascoterone’s list price ranges from $350 to $400 per 60-gram tube in the U.S. market. This premium pricing reflects its novelty, safety profile, and clinical benefits.

Reimbursement considerations

Insurance coverage is expanding, with initial co-pay support from manufacturers. Reimbursement policies significantly influence patient access and prescription volume.

Impact on revenue

Higher pricing supports margins, but payers may push for formulary tiering and discounts. Cost-effectiveness analyses published by health technology assessment agencies will shape future reimbursement policies.

Summary of market and financial outlook

Year	Estimated Sales (USD millions)	Key drivers	Risks
2023	100	Prescriber adoption, initial expansion	Competitive pressure, payor restrictions
2025	250	Expanded indications, increased geographies	Regulatory country approvals, clinical trial outcomes
2030	550+	Market penetration, new uses, high awareness	Patent expiration approaching, market saturation

Key Takeaways

• Clascoterone addresses unmet needs in acne management with localized anti-androgen activity.
• Market growth relies on expanding indications, geographic reach, and prescriber education.
• Revenue depends on pricing, reimbursement policies, and market acceptance.
• Competition from established topical therapies poses a challenge, but its unique mechanism offers differentiation.
• Regulatory and patent exclusivity timelines heavily influence the financial trajectory.

Frequently Asked Questions

1. What is Clascoterone's main innovation?
It is the first topical anti-androgen therapy approved for acne, reducing systemic hormone exposure with localized action.

2. How does Clascoterone compare in price to other topical treatments?
It is priced at approximately $350-$400 per tube, higher than many retinoid-based treatments, reflecting its novel mechanism and safety profile.

3. Are there approved off-label uses for Clascoterone?
No, off-label uses are not officially approved. Ongoing studies explore potential indications like androgenetic alopecia.

4. What regional markets are most promising for Clascoterone?
The U.S., European Union, and emerging markets with high acne prevalence and unmet needs present significant opportunities.

5. How does patent protection influence future revenues?
Patent rights extend into the late 2030s, providing exclusivity that supports premium pricing and limits competition in the near term.

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References

[1] Food and Drug Administration. (2020). FDA approves first topical treatment for acne in adolescents. https://www.fda.gov

[2] World Health Organization. (2021). Acne vulgaris data and prevalence. https://www.who.int

[3] Cassiopea SpA. (2021). Clascoterone (Winlevi) prescribing information.

[4] IQVIA. (2022). Dermatology treatment market analysis.

[5] EvaluatePharma. (2022). 2022 World Pharmaceutical Market Forecasts.