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.

The generic ingredient in WINLEVI is clascoterone. There is one drug master file entry for this compound. 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

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
Sun Pharmaceutical Industries Limited	PHASE2
Narrows Institute for Biomedical Research	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 Market Dynamics, Financial Trajectory, Patent Position, and Generic Risk

Last updated: August 18, 2026

WINLEVI, a 1% clascoterone cream marketed by Sun Pharmaceutical Industries, is the first FDA-approved topical androgen-receptor inhibitor for acne vulgaris. Its commercial opportunity depends on converting patients from established generic topical therapies, maintaining reimbursement despite a branded price, and expanding clascoterone into additional dermatology indications.

The product has a differentiated mechanism and a long patent runway relative to its 2021 U.S. launch. Its main commercial constraints are payer coverage, physician adoption, the low cost of generic acne treatments, and the absence of a currently approved second indication. Sun Pharma has not publicly reported a fully separated WINLEVI revenue line in its consolidated filings, making external prescription and partner disclosures more useful than audited brand-level revenue.

What is WINLEVI and how does clascoterone work?

WINLEVI is a topical cream containing 1% clascoterone, also known as cortexolone 17-alpha-propionate. The FDA approved it on August 27, 2020, for the topical treatment of acne vulgaris in patients aged 12 years and older. Sun Pharma launched the product in the United States in late 2021.[1,2]

Clascoterone acts locally as an androgen receptor inhibitor. Androgen signaling contributes to sebaceous gland activity and acne-related inflammation. WINLEVI is therefore positioned differently from:

• Retinoids such as tretinoin and adapalene, which regulate keratinization.
• Benzoyl peroxide, which reduces Cutibacterium acnes and inflammation.
• Topical antibiotics, which face resistance and duration-of-use limitations.
• Oral isotretinoin, which is reserved for severe or refractory acne.

The product is used twice daily as a thin layer to affected areas. Its topical route allows Sun Pharma to target patients and prescribers seeking a non-antibiotic, non-retinoid acne treatment.[1]

How large is the WINLEVI market?

WINLEVI competes in a large acne-treatment market, but its addressable branded segment is much smaller than the total acne population.

Acne affects a substantial majority of adolescents and many adults, yet most patients receive low-cost generic therapy. The commercial market is segmented by disease severity, age, sex, treatment tolerance, insurance status, and willingness to pay for newer products.

WINLEVI’s target market

The strongest commercial segments are likely to include:

1. Patients with inadequate response to generic retinoids or benzoyl peroxide.
2. Patients who cannot tolerate retinoid irritation.
3. Patients requiring a non-antibiotic topical option.
4. Adult women with hormonally influenced acne.
5. Dermatology patients receiving combination regimens.

WINLEVI is less likely to replace first-line generic therapy across the entire acne market. Its practical role is as an add-on or switch product for patients with persistent disease, tolerability problems, or a preference for a newer branded treatment.

Market access and pricing

The product’s commercial performance is highly sensitive to formulary placement. Generic tretinoin, adapalene, and benzoyl peroxide are inexpensive, while WINLEVI carries a branded prescription price. Insurance coverage, prior authorization, copay assistance, and pharmacy substitution therefore affect demand materially.

Sun Pharma has used commercial support programs and patient savings initiatives to reduce out-of-pocket costs. These measures can increase prescription volume but may reduce realized net price. The financial model depends on the balance between gross prescription growth, payer rebates, patient assistance, and specialty-pharmacy economics.

What are WINLEVI’s reported sales and financial trajectory?

Sun Pharma’s public financial reporting does not consistently provide a separate audited WINLEVI net-sales line. The company reports broader U.S. specialty, dermatology, and branded portfolios, while Cassiopea and Cosmo have disclosed partner-related economics in their corporate reporting.

The available financial picture indicates a product in commercial ramp-up rather than a mature branded franchise.

Indicator	Commercial implication
FDA approval	Established regulatory validity for acne
U.S. launch	Began in late 2021
Revenue stage	Early growth product during the first commercial years
Reporting structure	Brand-level revenue is not consistently separated by Sun Pharma
Principal growth driver	New patient starts and dermatologist adoption
Main pressure	Generic substitution and payer controls
Long-term upside	Additional clascoterone indications, particularly hair loss

Cosmo’s disclosures identify WINLEVI-related royalties and commercial economics as a contributor to the Cassiopea business. Those disclosures confirm product monetization but do not provide a complete public substitute for Sun Pharma’s U.S. brand sales because royalty revenue is only a percentage of underlying product sales.[3,4]

Revenue trajectory scenarios

Base case

WINLEVI grows through gradual dermatologist adoption and repeat use, but remains a specialty dermatology product. Growth moderates as the early-adopter pool declines and payers impose tighter controls.

Upside case

Sun Pharma expands coverage, improves patient affordability, increases combination use, and obtains approval for a second indication. A hair-loss indication would materially enlarge the opportunity because androgen signaling is central to androgenetic alopecia.

Downside case

Payers place WINLEVI behind generic retinoids and benzoyl peroxide. Patients discontinue because of cost or limited incremental benefit. Prescribers reserve the product for later-line use, limiting annual treatment volume.

What patents protect WINLEVI?

WINLEVI’s intellectual-property position includes formulation, composition, and use-based protection around topical clascoterone. The FDA Orange Book is the primary reference for patents listed against NDA 213433.[5]

Core patent protection

The commonly cited core U.S. patent for WINLEVI is U.S. Patent No. 10,881,659. Public patent databases and commercial patent analyses associate this patent with protection extending into 2032, before any patent-term adjustment or extension analysis.[6]

The patent estate is important because the product has no conventional small-molecule NCE exclusivity remaining after the FDA’s five-year exclusivity period. The NCE period is expected to expire in August 2025, subject to the precise FDA regulatory exclusivity record and any applicable pediatric extension.[1,5]

Protection type	WINLEVI relevance
FDA approval	August 27, 2020
NCE exclusivity	Expected to run through August 2025
Core composition/formulation patent	Extends into the early 2030s based on publicly cited patent data
Orange Book	Relevant for ANDA patent-certification and Paragraph IV analysis
Method-of-use rights	Potentially relevant to acne treatment and later indications
Geographic scope	U.S. rights are commercially controlled through Sun Pharma’s agreement with Cassiopea

The exact enforceability of the estate depends on claim scope, prosecution history, terminal disclaimers, patent-term adjustment, Orange Book listings, and any later-issued patents. A listed patent does not guarantee market exclusivity if an ANDA applicant succeeds in litigation or obtains a favorable non-infringement or invalidity outcome.

What is the Orange Book status of WINLEVI?

WINLEVI is approved under NDA 213433. The Orange Book identifies the approved drug product and any patents submitted by the NDA holder for listing.[1,5]

The NCE exclusivity period is separate from patent protection. Once NCE exclusivity expires, an ANDA applicant may be able to file a generic application, subject to the certifications required for listed patents.

Potential ANDA pathways include:

• Paragraph I certification if no patent is listed.
• Paragraph II certification if a listed patent has expired.
• Paragraph III certification accepting delayed launch until patent expiration.
• Paragraph IV certification asserting that a listed patent is invalid, unenforceable, or not infringed.

For WINLEVI, Paragraph IV activity would be commercially meaningful because the product’s differentiation is concentrated in the active ingredient, formulation, and topical delivery system. Generic competition could emerge before the stated patent expiry if the applicant prevails in litigation or reaches a settlement permitting an earlier launch.

When does WINLEVI lose exclusivity?

WINLEVI does not lose all exclusivity on one date.

The key dates are:

Event	Timing
FDA approval	August 27, 2020
Commercial launch	Late 2021
Expected NCE expiration	August 2025
Core patent expiration commonly cited	April 2032, before any applicable adjustment
Potential generic entry	After patent settlement, litigation victory, or patent expiry

NCE expiry is the earliest major regulatory opening for ANDA filing and potential Paragraph IV challenges. It does not itself authorize immediate generic launch if valid listed patents remain in force.

A patent-term extension, pediatric exclusivity, patent-term adjustment, litigation stay, or settlement could change the effective date. The commercial generic-entry date will depend on the Orange Book record and any court or settlement outcome.

Which companies are challenging WINLEVI?

No major public Paragraph IV challenge or material WINLEVI patent litigation was identified in the principal public FDA, company, and litigation disclosures reviewed through mid-2024.

The most likely future challengers are large generic dermatology companies with topical manufacturing capabilities, including firms such as Viatris, Teva, Sandoz, Perrigo, Amneal, and privately held topical manufacturers. A challenge would require more than reproducing clascoterone as an active ingredient. The applicant would need to address the cream formulation, bioequivalence pathway, manufacturing controls, and listed patent claims.

The absence of a disclosed challenge does not eliminate future risk. The NCE expiry in 2025 creates a natural point for ANDA filings and Paragraph IV certifications.

What formulations are protected by WINLEVI patents?

WINLEVI’s formulation is commercially important because clascoterone is delivered as a topical 1% cream rather than an oral androgen receptor inhibitor.

Formulation-related barriers can include:

• Concentration of clascoterone.
• Cream vehicle and excipient composition.
• Drug uniformity and physical stability.
• Release and permeation characteristics.
• Manufacturing process and scale-up controls.
• Container-closure compatibility.
• Microbiological quality and shelf life.

A generic applicant may challenge formulation claims even if it does not copy every excipient. The scope of any resulting litigation would turn on claim construction and whether the proposed generic falls within the listed claims.

Does WINLEVI have method-of-use or hair-loss patent value?

WINLEVI’s approved indication is acne vulgaris. Clascoterone has also been investigated for androgenetic alopecia, commonly called male-pattern hair loss. Hair-loss development could create a second commercial pathway and extend the value of the active ingredient beyond acne.

The hair-loss opportunity is strategically important because:

• The patient population is substantially larger than the prescription acne segment.
• Treatment is chronic, supporting recurring revenue.
• Androgen receptor biology is directly relevant to the disease.
• A second indication could support new method-of-use patents and regulatory exclusivity.
• Dermatologists already familiar with WINLEVI would be a natural prescriber base.

Cassiopea and Cosmo have reported development work involving clascoterone for scalp hair loss. Approval is not guaranteed, and a successful hair-loss program would require separate clinical, regulatory, manufacturing, and commercial execution.[3,4]

How does WINLEVI compare with competing acne drugs?

Product or class	Mechanism	Status	Commercial advantage	Main limitation
WINLEVI	Topical androgen receptor inhibition	Branded FDA-approved product	Novel mechanism, non-antibiotic	Cost and limited brand history
Tretinoin	Retinoid	Mostly generic	Low price, established efficacy	Irritation and adherence
Adapalene	Retinoid	Generic and OTC	Broad access, low price	Irritation and variable response
Benzoyl peroxide	Antimicrobial and keratolytic	Generic and OTC	Low cost, familiar use	Dryness and irritation
Topical clindamycin	Antibiotic	Generic	Familiar physician use	Resistance concerns
Spironolactone	Oral antiandrogen	Generic, off-label for acne	Low cost, useful in selected women	Systemic exposure and monitoring
Isotretinoin	Oral retinoid	Generic	Strong efficacy in severe acne	Significant safety and monitoring burden

WINLEVI’s strongest competitive claim is mechanism differentiation. Its weakest point is economic substitution: most competing treatments are inexpensive, familiar, and supported by long clinical experience.

What manufacturing and intellectual-property barriers affect generic entry?

Topical generic drugs can be more difficult to develop than simple oral tablets. A potential WINLEVI generic must demonstrate pharmaceutical equivalence and satisfy FDA requirements for topical product performance.

Relevant barriers include:

• Complex semisolid formulation development.
• Demonstration of comparable active-ingredient distribution.
• Manufacturing consistency across batches.
• In vitro release testing and, where required, clinical or pharmacokinetic studies.
• Stability under commercial storage conditions.
• Facility inspection and quality-system compliance.
• Patent risk involving composition, formulation, and use claims.

These barriers can delay competition, but they are not equivalent to biologic barriers. WINLEVI is a small-molecule topical product, so it does not have biosimilar risk in the technical sense. The relevant threat is ANDA-based generic competition, not a 351(k) biosimilar pathway.

What licensing deals govern WINLEVI?

Cassiopea developed clascoterone and licensed U.S. and Canadian commercial rights to Sun Pharma. Sun Pharma is responsible for commercializing WINLEVI in the United States, while Cassiopea and its parent Cosmo participate through milestone, royalty, and related economic arrangements disclosed in company filings.[3,4]

The arrangement gives Sun Pharma control over the commercial launch and distribution platform. It gives Cassiopea and Cosmo exposure to product growth without bearing the full cost of U.S. commercialization.

The strategic value of the agreement depends on:

• Royalty rates and milestone obligations.
• Sun Pharma’s promotional investment.
• Geographic rights outside the United States and Canada.
• Development responsibility for hair-loss indications.
• Ownership of follow-on patents and formulations.
• Termination and reversion provisions.

What generic entry risks exist for WINLEVI?

The generic-entry risk is moderate in the near term and rises after NCE expiry.

Near-term risk

Before the core patent expiry, a generic entrant would likely need to challenge listed patents or negotiate a settlement. The absence of publicly identified litigation through mid-2024 reduces immediate disruption risk but does not eliminate filing risk after August 2025.

Medium-term risk

The first Paragraph IV challenge could trigger the statutory 30-month stay for the relevant ANDA, assuming the patent holder brings timely litigation. The stay would delay approval, not necessarily prevent a generic launch after the applicable period.

Long-term risk

If the core patent survives through 2032 and no settlement permits earlier entry, WINLEVI could retain a protected U.S. market for more than a decade after launch. If formulation and method-of-use claims are weak, generic manufacturers could obtain earlier entry by designing around individual claims.

How strong is the WINLEVI patent estate?

WINLEVI has a stronger position than a product protected only by regulatory exclusivity because its commercial protection extends through listed patent rights into the early 2030s. Its estate is less secure than a broad composition-of-matter estate covering a new molecular entity across multiple formulations and indications.

The principal strengths are:

• Novel active ingredient in an approved acne product.
• Distinct topical mechanism.
• Formulation and use-based protection.
• Sun Pharma’s established U.S. dermatology infrastructure.
• Potential follow-on value in hair loss.

The principal weaknesses are:

• Generic applicants can target a small-molecule topical product through the ANDA pathway.
• The total patent estate appears narrower than those of blockbuster systemic drugs with multiple composition, formulation, and manufacturing patents.
• The commercial product currently relies heavily on one approved indication.
• Generic acne alternatives are widely available at low cost.

Key Takeaways

• WINLEVI is the first FDA-approved topical androgen receptor inhibitor for acne.
• Sun Pharma launched it in the United States in late 2021 under rights licensed from Cassiopea.
• Brand-level Sun Pharma revenue is not consistently disclosed, but partner disclosures indicate an active royalty-generating commercial product.
• The product’s commercial growth depends on payer coverage, patient affordability, and dermatologist adoption.
• NCE exclusivity is expected to expire in August 2025.
• The principal publicly cited U.S. patent extends into the early 2030s, commonly reported to April 2032 before any adjustment.
• No major public Paragraph IV challenge was identified through mid-2024.
• WINLEVI faces generic rather than biosimilar risk.
• Hair-loss development is the main potential catalyst for a larger market and additional intellectual-property value.
• Generic competition is unlikely to be immediate solely because NCE exclusivity expires, but ANDA filings and Paragraph IV litigation risk increase from 2025 onward.

FAQs

Is WINLEVI a biologic or a small-molecule drug?

WINLEVI is a small-molecule topical drug containing clascoterone. Future competition would use the ANDA generic pathway rather than the FDA biosimilar pathway.

Is clascoterone approved for hair loss?

No. WINLEVI is FDA-approved for acne vulgaris. Clascoterone has been investigated for androgenetic alopecia, but that use requires separate regulatory approval.

Can WINLEVI be substituted automatically by a generic?

Automatic substitution generally depends on an FDA-approved therapeutically equivalent generic and state pharmacy-substitution rules. No approved generic substitution was identified in the reviewed public records through mid-2024.

What is the principal investment risk for WINLEVI?

The main risk is slower-than-expected branded adoption because patients and payers can substitute low-cost generic acne therapies. The next major legal risk is a Paragraph IV challenge after NCE exclusivity expires.

What would most improve WINLEVI’s financial trajectory?

The strongest potential drivers are broader insurance coverage, sustained refill rates, improved patient affordability, approval in androgenetic alopecia, and additional patents covering follow-on formulations or uses.

References

1. U.S. Food and Drug Administration. (2020). WINLEVI (clascoterone) cream, 1%: Prescribing information. https://www.accessdata.fda.gov
2. Sun Pharmaceutical Industries Ltd. (2022). Annual report 2021-22. https://www.sunpharma.com
3. Cosmo Pharmaceuticals N.V. (2024). Annual report 2023. https://www.cosmopharma.com
4. Cassiopea S.p.A. (2021). WINLEVI commercial and corporate disclosures. https://www.cassiopea.com
5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files
6. U.S. Patent and Trademark Office. (2021). U.S. Patent No. 10,881,659. https://patents.google.com/patent/US10881659B2/en

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