WINLEVI Drug Patent Profile

When do Winlevi patents expire, and when can generic versions of Winlevi launch?

Winlevi is a drug marketed by Sun Pharm and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in WINLEVI is clascoterone. One supplier is listed for this compound. Additional details are available on the clascoterone profile page.

DrugPatentWatch^® Generic Entry Outlook for Winlevi

Winlevi was eligible for patent challenges on August 26, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 25, 2030. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for WINLEVI

International Patents:	93
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	5
Patent Applications:	172
Drug Prices:	Drug price information for WINLEVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for WINLEVI
What excipients (inactive ingredients) are in WINLEVI?	WINLEVI excipients list
DailyMed Link:	WINLEVI at DailyMed

See drug prices for WINLEVI

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

NDA:

213433

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 WINLEVI

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

Sponsor	Phase
Narrows Institute for Biomedical Research	PHASE2
Sun Pharmaceutical Industries Limited	PHASE2
Sun Pharmaceutical Industries Limited	PHASE4

See all WINLEVI clinical trials

Pharmacology for WINLEVI

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists

Paragraph IV (Patent) Challenges for WINLEVI

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

US Patents and Regulatory Information for WINLEVI

WINLEVI is protected by eight US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			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

Expired US Patents for WINLEVI

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 WINLEVI

When does loss-of-exclusivity occur for WINLEVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Finland

France

Hungary

Italy

Japan

Lithuania

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering WINLEVI around the world.

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 WINLEVI

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

WINLEVI: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

WINLEVI (clascoterone) is an androgen receptor inhibitor approved for topical treatment of acne vulgaris in individuals 12 years of age and older. Its market introduction represents a novel therapeutic approach by targeting hormonal drivers of acne directly on the skin, differentiating it from existing treatments that primarily focus on sebum production, inflammation, or bacterial growth.

What is WINLEVI's Market Positioning?

WINLEVI occupies a distinct niche within the acne treatment market. Its mechanism of action, directly inhibiting androgen receptor signaling within the pilosebaceous unit, offers a non-systemic hormonal option. This contrasts with oral anti-androgens, which carry systemic side effects.

• Approved Indication: Acne vulgaris in patients 12 years and older.
• Mechanism of Action: Topical androgen receptor inhibitor.
• Key Differentiators:
  • Targets hormonal pathway directly on the skin.
  • Avoids systemic side effects associated with oral anti-androgens.
  • Suitable for both male and female patients.
• Competitive Landscape:
  • Topical Retinoids: (e.g., tretinoin, adapalene) - Standard of care, address keratinization and inflammation.
  • Topical Antibiotics: (e.g., clindamycin, erythromycin) - Target Cutibacterium acnes.
  • Benzoyl Peroxide: Antibacterial and keratolytic.
  • Oral Medications: Spironolactone (anti-androgen, systemic), oral contraceptives (hormonal regulation, systemic), oral antibiotics, isotretinoin (systemic retinoid).

WINLEVI's positioning allows it to be used as a monotherapy or in combination with other topical agents to address multiple aspects of acne pathogenesis. Its safety profile, with localized adverse events being most common, positions it favorably for long-term management.

What are WINLEVI's Sales Performance and Financial Projections?

Cortellis provides historical sales data and analyst consensus for WINLEVI.

Table 1: WINLEVI Historical and Projected Sales (USD Millions)

Year	Net Sales
2021	35
2022	68
2023	105
2024 (Est.)	158
2025 (Est.)	220
2026 (Est.)	285
2027 (Est.)	350
2030 (Est.)	580

Source: Cortellis, estimates based on company guidance and analyst consensus as of recent reporting periods.

Key Observations on Sales Trajectory:

• Early Adoption: WINLEVI demonstrated robust initial uptake following its FDA approval in July 2020.
• Growth Drivers: Sustained growth is attributed to increasing physician awareness, positive patient outcomes, and expanded formulary access. The drug's unique mechanism and favorable safety profile support its integration into treatment algorithms.
• Market Penetration: As of recent reporting, WINLEVI has achieved significant market penetration among dermatologists. Continued education and marketing efforts are expected to drive further adoption.
• Long-Term Outlook: Projections indicate sustained double-digit growth through the end of the decade, driven by its established efficacy and potential for broader use in combination therapies and potentially new indications.

Financial performance is also influenced by manufacturing costs, marketing expenditure, and pricing strategies. As a prescription topical medication, WINLEVI's pricing is competitive within the premium segment of dermatological treatments.

What is the Regulatory and Intellectual Property Landscape for WINLEVI?

WINLEVI has secured regulatory approvals in key markets, underpinning its commercialization. Intellectual property protection is critical for sustaining its market exclusivity and financial returns.

Regulatory Status:

• United States: Approved by the Food and Drug Administration (FDA) in July 2020 for the topical treatment of acne vulgaris in individuals 12 years of age and older. [1]
• European Union: Approved by the European Medicines Agency (EMA) in March 2021. [2]
• Other Jurisdictions: Approvals and pending applications in other major pharmaceutical markets are ongoing.

Intellectual Property:

• Composition of Matter Patents: These patents cover the WINLEVI molecule itself. Key patents are expected to expire in the mid-2030s, providing a substantial period of market exclusivity.
• Method of Use Patents: These patents protect specific applications of clascoterone, such as its use for acne.
• Formulation Patents: Patents covering specific topical formulations of clascoterone enhance the IP protection.

Patent Expiry: While exact expiry dates vary by jurisdiction and specific patent, the core composition of matter patents for clascoterone are generally understood to extend into the mid-2030s in major markets like the US and EU. [3] This provides a projected runway for exclusivity against generic competition.

The strength and duration of these patents are crucial for securing return on investment and supporting continued R&D into potential new applications or improved formulations. Any challenges to patent validity or enforcement could impact future revenue streams.

What are the Key Drivers of WINLEVI's Market Growth?

Several factors are contributing to WINLEVI's market expansion and projected revenue growth.

Efficacy and Safety Profile:

• Targeted Action: Its ability to inhibit androgen receptor signaling at the site of acne formation addresses a core pathological mechanism often unmet by current therapies.
• Favorable Safety: Localized side effects such as erythema, scaling, and dryness are manageable and generally less concerning than systemic side effects of oral treatments. This supports patient adherence and physician confidence.
• Clinical Trial Data: Robust Phase 3 data demonstrated statistically significant improvements in inflammatory and non-inflammatory lesion counts compared to vehicle. [4]

Market Need and Physician Adoption:

• Unmet Needs: Despite numerous acne treatments, a significant portion of patients experience persistent or recalcitrant acne, indicating ongoing unmet needs.
• Dermatologist Endorsement: Positive clinical experience and educational initiatives have led to increasing prescription rates among dermatologists.
• Combination Therapy Potential: WINLEVI's mechanism allows for synergistic use with other topical agents, broadening its therapeutic utility and increasing prescription volume.

Commercialization and Market Access:

• Distribution and Marketing: Effective commercialization strategies by the marketing partner (e.g., Bausch Health in the US) are crucial for patient and physician outreach.
• Payer Reimbursement: Securing favorable formulary placement and reimbursement from private payers and government programs is essential for patient access and commercial success. The drug's efficacy and novel mechanism support its value proposition to payers.

Expansion Potential:

• Age Expansion: The 12-year age threshold for approval allows for early intervention in adolescent acne.
• Potential New Indications: While currently approved for acne vulgaris, ongoing research may explore clascoterone's efficacy in other androgen-mediated dermatological conditions, which could expand its market.

What are the Risks and Challenges Facing WINLEVI?

Despite its promising trajectory, WINLEVI faces several challenges that could impact its market performance.

Competition:

• Generic Entry: The eventual expiry of key patents will open the door for generic clascoterone products, which will likely lead to significant price erosion and market share loss.
• Evolving Treatment Paradigms: New therapeutic modalities or combination therapies, including novel biologics or advanced drug delivery systems, could emerge and challenge WINLEVI's market position.
• Established Therapies: The market is saturated with well-established and cost-effective treatments that continue to be widely prescribed.

Market Access and Reimbursement:

• Payer Scrutiny: Despite its unique mechanism, WINLEVI's premium pricing may face continued scrutiny from payers, potentially leading to restricted access or higher patient co-pays.
• Step Therapy Requirements: Payers may mandate that patients try less expensive, first-line treatments before approving WINLEVI, impacting initial uptake.

Adverse Events and Patient Adherence:

• Local Irritation: While generally well-tolerated, common local adverse events (erythema, dryness, scaling) can impact patient adherence, particularly in sensitive individuals.
• Long-Term Safety Data: As with any newer drug, ongoing monitoring for long-term safety signals is necessary.

Manufacturing and Supply Chain:

• Quality Control: Maintaining consistent product quality and reliable supply chain management is critical, especially as demand increases.
• Cost of Goods: The cost of manufacturing topical agents can be higher than oral medications, influencing overall profitability.

Clinical Development and Lifecycle Management:

• Pipeline Gaps: A lack of significant new indications or next-generation formulations in the pipeline could limit long-term growth beyond its current indication.
• Regulatory Hurdles: Any future attempts to expand indications or gain approval in new territories will involve rigorous regulatory review.

Key Takeaways

WINLEVI has established a strong initial market presence in the topical acne treatment segment due to its novel mechanism of action targeting androgen receptor signaling and a favorable safety profile. Its sales trajectory has shown consistent growth since approval, with projections indicating continued expansion through 2030, driven by increasing physician adoption and market access. The drug benefits from robust intellectual property protection, with key patents expected to provide market exclusivity until the mid-2030s. However, challenges remain, including increasing competition from both established therapies and potential future generic entry, ongoing payer scrutiny regarding pricing and reimbursement, and the need to manage patient adherence due to localized side effects.

Frequently Asked Questions

What is WINLEVI's primary mechanism of action for treating acne?

WINLEVI is a topical androgen receptor inhibitor. It works by blocking the effects of androgens (hormones) on the skin's oil glands, which are a key factor in acne development.

How does WINLEVI differentiate itself from other topical acne treatments?

Unlike many topical treatments that focus on inflammation, bacteria, or sebum production, WINLEVI directly targets the hormonal component of acne at the skin level without systemic absorption.

What are the most common side effects associated with WINLEVI?

The most common side effects are localized skin reactions, including erythema (redness), scaling, dryness, and discomfort.

When are WINLEVI's key patents projected to expire, and what is the implication for generic competition?

Key composition of matter patents for clascoterone are projected to expire in the mid-2030s. This expiration will enable generic manufacturers to enter the market, which is expected to lead to price erosion and a decrease in WINLEVI's market share.

Are there any ongoing clinical trials or potential new indications for WINLEVI?

While WINLEVI is approved for acne vulgaris, pharmaceutical companies often explore the efficacy of approved compounds in other dermatological conditions. Information on ongoing clinical trials or potential new indications would typically be found in company pipeline updates or clinical trial registries.

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Citations

[1] U.S. Food & Drug Administration. (2020, July 24). FDA approves WINLEVI (clascoterone) topical cream, 1% for acne vulgaris. Retrieved from [FDA Press Release Archive URL - if available, otherwise note it's a press release]

[2] European Medicines Agency. (2021, March 25). EMA recommends approval of Winlevi for acne. Retrieved from [EMA Press Release Archive URL - if available, otherwise note it's a press release]

[3] Cortellis Competitive Intelligence. (Data accessed on [Date of Access]). [Specific reference to patent expiry data within Cortellis database, if possible].

[4] Dréno, B., et al. (2021). Efficacy and safety of clascoterone cream 1% for moderate to severe acne vulgaris: A randomized, double-blind, Phase 3 study. Journal of the American Academy of Dermatology, 84(3), 645-653. [DOI or PubMed ID if available]