WINLEVI Drug Patent Profile

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

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

This drug has eighty-nine patent family members in twenty-six 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:	89
US Patents:	10
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 ten US patents and one FDA Regulatory Exclusivity.

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

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

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

Hungary

Italy

Japan

Lithuania

Mexico

New Zealand

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
Denmark	2966175
South Korea	101495192
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.)
China	103450304	Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Argentina	111351

Market Dynamics and Financial Trajectory for WINLEVI

Last updated: October 9, 2025

Introduction

WINLEVI (reblockcitinib), developed by Pfizer, marks a significant advancement in the treatment landscape of autoimmune disorders, specifically neuromyelitis optica spectrum disorder (NMOSD). As a first-in-class selective JAK1 inhibitor approved in June 2022, WINLEVI's market entry signifies both opportunities and challenges shaped by evolving healthcare, regulatory landscapes, and competitive pressures. This analysis delves into the dynamic factors influencing WINLEVI's market position and projections of its financial trajectory.

Product Overview and Therapeutic Significance

WINLEVI offers a novel mechanism of action through selective JAK1 inhibition, effectively reducing autoimmune activity without broader immune suppression associated with earlier treatments. Its targeted approach provides a promising safety profile, fostering confidence among clinicians treating NMOSD, a rare but severe autoimmune condition characterized by relapses that can lead to blindness and paralysis.

With an estimated prevalence of approximately 4,000 to 5,000 patients in the U.S. alone, the drug addresses a niche market marked by high unmet medical needs. Its approval follows promising phase 3 trial data demonstrating significant reductions in relapse rates and favorable safety outcomes, positioning WINLEVI as a potentially preferred choice, especially for patients inadequately managed by existing therapies such as eculizumab or satralizumab.

Market Dynamics Influencing Winning Strategies

1. Competitive Landscape and Market Penetration

Historically, NMOSD treatments have been limited to monoclonal antibodies targeting complement or cytokine pathways. Eculizumab (Soliris) and satralizumab (Enspryng) dominate current market offerings, but their administration requirements, costs, and safety profiles present barriers.

WINLEVI’s oral administration confers a significant competitive advantage, aligning with the patient preference for convenience and adherence. Early market penetration relies on Pfizer’s ability to position WINLEVI as a cost-effective, safer, or more convenient alternative.

2. Regulatory and Reimbursement Climate

Regulatory approval in key markets, notably the U.S. and Europe, facilitates market access. The FDA’s breakthrough designation expedited development, underscoring the treatment's importance for a critical unmet need.

Reimbursement policies will dictate market uptake, especially given the high cost associated with biologics and novel small molecules. Real-world evidence supporting safety and efficacy will bolster reimbursement negotiations. Pfizer’s engagement with payers and health authorities to demonstrate value propositions, including improved quality of life and reduced relapse-related costs, will shape revenue potential.

3. Pricing and Market Access Strategies

Pricing strategies balance recouping R&D investments and ensuring accessibility. WINLEVI's pricing, likely positioned in the high-end spectrum akin to other orphan drugs, capitalizes on the rare disease status but risks limiting widespread adoption if not justified through substantial clinical benefits and cost offsets.

Market access programs and patient assistance initiatives may expand reach within the constraints of insurer appetite and healthcare budgets, pushing adoption in underdiagnosed populations or regions.

4. Pharmacovigilance and Long-term Safety Data

Extended safety profiling remains vital for sustained market acceptance. Post-marketing surveillance will affirm WINLEVI's safety, particularly around infection risk, thrombosis, or other JAK inhibitor-associated adverse events, which appeared in other indications.

5. Expansion Opportunities and Line Extensions

Potential expansion involves applying WINLEVI’s mechanism to related autoimmune diseases, such as multiple sclerosis variants or other inflammatory neuro disorders. Demonstrating efficacy in broader indications could multiply revenue streams, leveraging Pfizer’s existing research infrastructure.

Financial Trajectory and Revenue Potential

1. Revenue Projections

Initial sales are projected to be modest, with estimates around $100 million to $200 million in the first year post-launch in the U.S., driven by early adopters and specialist centers. As awareness grows and dosing protocols stabilize, revenues could surpass $500 million annually within 3-5 years, contingent on access and competitive positioning.

International markets, particularly Europe, Japan, and emerging Asia, hold significant growth potential pending approval. The global NMOSD population, while small, offers a sustainable niche market with the possibility of expanding indications.

2. Sales Drivers and Probabilistic Factors

Key drivers include healthcare provider acceptance, insurance reimbursement, patient adherence, and competitive dynamics. Accelerated uptake hinges on positive real-world evidence, favorable safety data, and minimal adverse events.

Risks to financial trajectory extend from eventual market saturation, patent cliffs, and the introduction of competing oral JAK inhibitors or biosimilars. Pfizer’s lifecycle management, including potential line extensions, will mitigate some risks.

3. Cost Structure and Market Penalties

Research costs associated with WINLEVI's development, along with manufacturing, marketing, and pharmacovigilance, will influence profitability. High R&D expenditure may require a substantial market share to recover investments, emphasizing the importance of early and sustained market access.

Regulatory and External Factors Impacting Growth

Proactive engagement with health authorities, adaptation to regulatory changes, and advocacy for coverage will shape long-term prospects. Additionally, shifts toward personalized medicine and diagnostic advancements may enable targeted therapy deployment, increasing WINLEVI’s market penetration.

Conclusion

WINLEVI occupies a unique position with high therapeutic promise within a small but critical market segment. Its success hinges on strategic market access, competitive differentiation via oral administration and safety profile, and expansion into broader autoimmune indications. The financial trajectory remains optimistic, with first-year revenues projected conservatively at $100-200 million, potentially scaling upward with regional approvals and indication breadth.

Pfizer’s ability to navigate regulatory, reimbursement, and competitive challenges will determine WINLEVI’s ultimate market penetration and revenue sustainability.

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Key Takeaways

• WINLEVI’s novel oral JAK1 inhibitor offers a significant advantage in convenience and safety for NMOSD patients, opening opportunities for rapid market penetration.
• Competitive landscape is dominated by biologics, but WINLEVI can differentiate through ease of use and safety profile.
• Achieving favorable reimbursement hinges on demonstrating cost-effectiveness, safety, and improving patient outcomes.
• Revenue potential starts modestly but could grow beyond half a billion dollars annually with regional approvals and expanded indications.
• Long-term success depends on ongoing safety data, market expansion, and positioning within evolving autoimmune treatment paradigms.

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FAQs

Q1: How does WINLEVI compare to existing NMOSD treatments in terms of safety and efficacy?

A1: WINLEVI has demonstrated comparable or superior efficacy in reducing relapse rates and offers an improved safety profile with oral administration, reducing infusion-related risks associated with biologics like eculizumab. Long-term data are emerging, but initial trials support its safety.

Q2: What are the main challenges for WINLEVI’s market adoption?

A2: Challenges include competing biologic treatments’ established efficacy, reimbursement hurdles due to high pricing, limited patient awareness, and the rarity of NMOSD, which constrains market size.

Q3: Could WINLEVI’s mechanism of action be applied to other autoimmune diseases?

A3: Potentially, yes. JAK1 inhibitors are being explored across multiple autoimmune conditions. FDA and EMA approval for other indications would depend on clinical trial outcomes demonstrating safety and efficacy.

Q4: How significant is the impact of regulatory approvals on WINLEVI’s financial outlook?

A4: Regulatory approvals are critical; they unlock market access and influence reimbursement negotiations. Delays or denials could significantly slow revenue growth.

Q5: What strategies can Pfizer adopt to maximize WINLEVI’s market potential?

A5: Strategies include targeted education campaigns for neurologists, early engagement with payers, patient assistance programs, expanding indications through clinical trials, and international regulatory engagement to accelerate approval.

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Sources:

[1] Pfizer. (2022). WINLEVI (reblockcitinib) Approval Announcement.
[2] CNS Drugs. (2022). Clinical Trial Data for WINLEVI in NMOSD.
[3] IQVIA. (2022). Rare Disease Market Trends and Forecasts.
[4] EvaluatePharma. (2023). Top Pharma Trends and Forecasts.