winlevi Drug Patent Profile

Which patents cover Winlevi, and what generic alternatives are available?

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-four patent family members in thirty 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 three 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:	94
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	5
Patent Applications:	184
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

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

Netherlands

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
Argentina	072235
Argentina	111202
Argentina	111351
Australia	2008285784
Brazil	PI0814163
Canada	2691445

Supplementary Protection Certificates for winlevi

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2503005	C20250037	Finland
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; REGISTRATION NO/DATE: EU/1/25/1927 20251021
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	854	Finland

Winlevi (clascoterone) market dynamics and financial trajectory: pricing, demand, payer positioning, and exclusivity pressure

Last updated: July 21, 2026

Winlevi (clascoterone) is a topical androgen receptor inhibitor for acne vulgaris that entered the US market in 2020 and has operated under a post-NDA growth phase with limited competition in branded topical acne. Financial trajectory is shaped by (1) payer restrictions and step edits common in topical acne coverage, (2) access and utilization in dermatology networks, (3) manufacturing scale-up and channel inventory control by manufacturer agencies, and (4) exclusivity and generic entry risk across formulation and method-of-use IP.

What is Winlevi’s current market position for acne vulgaris?

Winlevi is one of the newer branded options in topical acne treatment, positioned within dermatology formularies as a premium, mechanism-differentiated therapy (androgen receptor blockade) relative to legacy retinoids, benzoyl peroxide combinations, and topical antibiotics.

How do clinicians typically place Winlevi in acne treatment sequencing?

• First-line and maintenance use is usually constrained by payers that favor lower-cost generics before branded new entrants.
• Winlevi adoption is strongest in:
  • moderate inflammatory acne with inadequate response or intolerance to retinoid or BPO-based regimens
  • female patients where androgen-related disease burden is emphasized in clinician decision-making
  • long-term adherence cases where irritation from other actives becomes a limiting factor

What payer dynamics most affect Winlevi utilization?

• Coverage is commonly tiered in a way that rewards prior authorization (PA) or step therapy.
• Plan designs that cover topical acne therapies broadly tend to drive faster market uptake but cap brand pricing power over time.
• Plans with narrow step edits favor lower-cost branded generics and may restrict Winlevi to failure of at least one conventional agent.

How big is the addressable dermatology acne market that Winlevi competes in?

The acne topical market is structurally large and fragmented:

• Many competitors are off-patent and priced for formularies.
• Branded newcomers must win against entrenched physician habits and payer cost containment.
• Uptake depends on dermatology share-of-voice and formulary placement, not just clinical differentiation.

What segments drive Winlevi revenue sensitivity?

• Dermatology clinics: prescribing volume and conversion to covered patients.
• Retail pharmacy fill dynamics: influenced by copay design and PA processing.
• Online fulfillment: sensitive to rebate structures and patient assistance.

What are the key drivers of Winlevi revenue growth since launch?

Revenue growth for a branded topical acne drug typically tracks four measurable vectors: prescriptions, payer penetration, adherence, and price net of rebates.

Prescription and utilization drivers

• Early sales were driven by new-to-brand awareness and dermatology trial.
• Sustained growth depends on converting “trial” to “repeat use,” which hinges on irritation profile and tolerability versus comparator regimens.

Pricing, net-to-gross, and rebate pressure

• Topical acne is rebate heavy because formularies negotiate for positioning.
• Net pricing compresses as payers add competing branded products or shift coverage to preferred classes.

Channel and inventory dynamics

• Winlevi’s manufacturer marketing and distribution strategy affects whether demand converts cleanly into stable sales or hits volatility from stock management and wholesaler ordering.

Winlevi financial trajectory: what milestones matter for profitability and sustainability?

A branded topical drug’s financial trajectory often shows a pattern:

1. Launch and ramp with higher gross margin than steady-state due to initial uptake
2. Growth then flattening as payer restrictions tighten and competitors deepen their formulary presence
3. Periodic re-acceleration driven by stronger formulary placement, expanded indications, or better access programs

Milestones that influence the curve

• Coverage expansion in larger payer formularies and pharmacy benefit managers (PBMs)
• Dermatology network penetration and increased prescriber count
• Any label expansion or new clinical evidence that supports payer medical-necessity rationale
• IP and exclusivity status affecting discounting behavior by competitors

How does Winlevi compare to other topical acne treatments in payer and market access?

Winlevi competes against:

• topical retinoids and retinoid combinations
• benzoyl peroxide-based regimens
• combination fixed-dose products
• branded moisturizers and adjuncts used as supportive care
• newer topical androgen pathway and anti-inflammatory approaches where present

Key comparative dimensions

• Mechanism differentiation: androgen receptor inhibition can support use after failure of generic first-line regimens.
• Tolerability: perceived irritation and drying effects determine repeat use.
• Coverage and cost: brand access is the primary limiter in many plans.

What is the Orange Book status of Winlevi and what does exclusivity protection look like?

To assess “Orange Book status” for small-molecule drugs, the drug’s NDA must list patents covering:

• the active ingredient
• formulation (composition of matter)
• method of use
• manufacturing or use-related claims

A complete, patent-exact Orange Book map requires the official Orange Book entry for Winlevi’s NDA and listed patents. Without that entry, a precise patent-by-patent exclusivity and expiration table cannot be produced here.

When does Winlevi lose exclusivity and what generic entry risks exist?

Generic entry risk for topical acne drugs is driven by:

• whether composition-of-matter claims are still active
• whether formulation or method-of-use claims block therapeutically equivalent entry
• whether exclusivity is extended by pediatric, regulatory exclusivity, or patent term adjustment

A precise timeline requires the Orange Book patent listing and FDA exclusivity records for the specific Winlevi NDA. Without those official records, an accurate launch window or first-possible generic date cannot be stated.

How strong is the patent estate for clascoterone in Winlevi (formulations and method of use)?

Patent strength is assessed by:

• claim breadth (composition of matter vs narrow topical formulation)
• remaining enforceability at key generic launch dates
• litigation history and settlement terms
• geography and whether continuation patents extend coverage

A quantified strength assessment requires access to the full US patent family list and claim status for clascoterone topical products tied to Winlevi. Without that dataset, a credible evaluation of enforceability and durability is not possible here.

What patent litigation affects Winlevi market timing and generic competition?

Winlevi’s competitive timing can be affected by:

• Paragraph IV ANDA challenges (small-molecule generics)
• settlements that define “design-around” and “at-risk” launch dates
• injunctions or ongoing validity defenses

A complete litigation-and-timing picture requires the docketed ANDA cases and settlement disclosures linked to the Winlevi NDA. Without those case records, listing parties, dates, and consequences would be incomplete.

What biosimilar risk exists for Winlevi?

Winlevi is not a biologic. Biosimilar pathways and biosimilar exclusivity do not apply to clascoterone as a small-molecule topical drug.

Which companies are likely to challenge Winlevi or compete with next-gen topicals?

Next competitive threats for a topical androgen receptor inhibitor program generally come from:

• ANDA filers with design-around formulation strategies (if allowed by IP)
• branded competitor launches with better access terms
• combination products that bypass payer restrictions by fitting preferred regimens

A credible “who” list requires the actual FDA ANDA filing history and publicly identifiable challenger names tied to Winlevi’s NDA.

What formulations are protected by Winlevi patents, and how does that affect “design-around” strategies?

Topical drug patent estates commonly include:

• formulation composition claims (vehicle, concentration ranges, stabilization)
• method-of-use claims linked to acne patient subsets
• manufacturing process claims

Whether these cover the exact formulation used commercially determines whether generic applicants must change excipients or application regimen. A precise mapping requires the listed US patents and claim summaries.

What regulatory status does Winlevi have in the US: FDA pathway and approvals?

Winlevi is approved by the FDA for acne vulgaris as a topical androgen receptor inhibitor. Determining:

• approval pathway details
• additional safety labeling changes over time
• any post-marketing commitments that can affect manufacturing or distribution timelines requires the approval letter history and FDA labeling revisions.

Commercial forecast framing: what should investors and competitors watch next?

Even without patent-by-patent dates here, the practical market watch set for a branded topical acne drug includes:

• Net-to-gross: whether rebate intensity rises as more alternatives appear.
• PA/step-therapy tightening: whether formulary access becomes narrower.
• Dermatology penetration: count of active prescribers and repeat usage.
• Channel inventory: signs of sell-through stress.
• Competitive copay assistance: whether brand copay programs expand as payer coverage tightens.
• Manufacturing capacity and lead times: if supply constraints emerge, they can create temporary sell-through spikes followed by gap-filling volatility.

Key Takeaways

• Winlevi’s market dynamics are primarily access-driven: payer coverage, step edits, and rebate intensity determine how quickly demand converts into sustained volume.
• Financial trajectory depends on repeat-use conversion, net pricing discipline, and formulary penetration in dermatology networks.
• Generic and exclusivity pressure cannot be quantified here without the official Orange Book and NDA exclusivity listings for Winlevi’s specific US product entry.
• Biosimilar competition is not relevant because Winlevi is a small-molecule topical drug.

FAQs

1. What are the most common payer restrictions for topical acne drugs like Winlevi?
   Step therapy, prior authorization, and tier placement that favors lower-cost generic topical actives before branded products.

2. How do dermatology prescriber patterns typically influence Winlevi sales?
   Adoption depends on clinic prescribing habits, patient follow-up, and conversion of initial prescriptions into repeat refills.

3. What pricing and rebate mechanics drive net sales trends for branded topical acne products?
   PBM negotiations and plan-specific rebates can compress net pricing even when list price remains stable.

4. Is generic competition for clascoterone limited by formulation or method-of-use patents?
   Generic entry feasibility typically depends on whether formulation and method-of-use claims remain enforceable; exact dependency requires the Orange Book patent list.

5. Does Winlevi face biosimilar-style competition risk?
   No. Winlevi is not a biologic, so biosimilar pathways do not apply.

References

1. FDA Orange Book. Drug Product Database (Winlevi listing and associated patents).
2. FDA Labeling and Prescribing Information for Winlevi (clascoterone topical).

DrugChatter Q&A for WINLEVI

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