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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 nine 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for WINLEVI

International Patents:	89
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	88
Drug Prices:	Drug price information 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

Constraining patent/regulatory exclusivity:

8,785,427

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.

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 nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,785,427.

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	11,207,332		Y
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes	9,211,295		Y
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes	9,486,458
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes	11,938,141		Y
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes	10,159,682
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes	8,143,240
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes	9,433,628		Y

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
China	103450304	Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Russian Federation	2482190
Canada	2871039	PROCEDE ENZYMATIQUE POUR OBTENIR DES 17 ALPHA-MONOESTERS DE CORTEXOLONE ET/OU SES DERIVES 9,11-DESHYDRO (ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES)
New Zealand	599437
Serbia	53310
Japan	2016014045
Canada	2454675	ESTERS DE 17ALFA, 21-DIHYDROXYPREGNENE UTILISES COMME AGENTSANTIANDROGENES (17ALFA, 21-DIHYDROXYPREGNENE ESTERS AS ANTIANDROGENIC AGENTS)

WINLEVI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Winlevi

Introduction

Winlevi, a topical acne treatment developed by Cassiopea, a subsidiary of Cosmo Pharmaceuticals, has been making significant waves in the dermatology market. Approved by the U.S. FDA in August 2020 for the treatment of acne vulgaris in patients 12 years and older, Winlevi has shown promising market dynamics and a robust financial trajectory.

Approval and Mechanism of Action

Winlevi, or clascoterone cream 1%, is distinguished by its novel antiandrogen mechanism of action. This unique approach sets it apart from other acne treatments, making it an attractive option for patients and healthcare providers alike[3][4].

Market Uptake and Performance

Since its approval, Winlevi has experienced strong market uptake. In the U.S., it has become the #1 most prescribed topical acne product, highlighting its rapid acceptance by clinicians and patients. According to IQVIA data, Winlevi has been one of the most successful U.S. launches in the topical acne space in the last 15 years[1][2].

Distribution and Licensing Agreements

Cosmo Pharmaceuticals has secured several key distribution and licensing agreements to expand Winlevi's reach. For instance, Sun Pharma has the exclusive right to commercialize Winlevi in the U.S. and Canada, while Glenmark has the exclusive rights for 15 EU countries, South Africa, and the UK. These agreements include upfront payments, regulatory and sales milestones, and royalties on net sales, contributing significantly to Cosmo's financial performance[1][3].

Financial Performance of Cosmo Pharmaceuticals

The financial trajectory of Cosmo Pharmaceuticals has been significantly boosted by the success of Winlevi. In the first half of 2024, Cosmo reported robust financial results, with revenue soaring to €136.2 million from €43.7 million in the same period the previous year. The operating profit jumped to €87.0 million from €7.1 million, and the net profit increased to €76.1 million from €1.5 million. These figures are largely driven by the strong performance of Winlevi and other flagship products like GI Genius™[2].

Revenue Growth

The revenue growth is not only attributed to the direct sales of Winlevi but also to the various licensing agreements. For example, Cosmo received a $100 million upfront payment from Medtronic, with an additional $100 million expected later in the year. This influx of capital has strengthened Cosmo's financial position, with the company reporting a strong cash position of €133.4 million in cash and short-term investments as of June 2024[2].

Operational Costs and Profitability

While the revenue has seen a significant increase, operational costs have also risen. Net expenses increased to €49.2 million from €36.5 million, and personnel expenses rose to €19.9 million from €12.2 million. However, the overall profitability has improved substantially, with an EBITDA of €94.2 million and a net operating profit of €87.0 million[2].

Market Projections and Growth Potential

The EU acne market, where Winlevi is set to be commercialized by Glenmark, is projected to grow from USD 928.7 million in 2021 to USD 1,297.0 million in 2028. This growth is driven by the high prevalence of acne among teenagers and young adults, with over 90% of people aged 11 to 30 years affected by acne in Europe[1].

Peak Sales Forecast

In the U.S., Winlevi has a peak sales forecast of $419 million, according to analyst reports. This forecast underscores the drug's potential to capture a significant share of the acne treatment market[4].

Challenges and Future Outlook

Despite the initial success, there are potential challenges ahead. Analysts suggest that clinician and patient interest could wane if real-world clinical data does not align with the promising results from clinical trials. Patient compliance with the topical treatment will be crucial to maintaining long-term results. Additionally, the drug's mechanism is particularly beneficial for adult females, who are more compliant with topical treatments[4].

Key Takeaways

• Strong Market Uptake: Winlevi has become the #1 most prescribed topical acne product in the U.S.
• Robust Financial Performance: Cosmo Pharmaceuticals has seen significant revenue and profit growth driven by Winlevi.
• Expansive Distribution: Licensing agreements with Sun Pharma and Glenmark have expanded Winlevi's reach to multiple regions.
• Market Growth Potential: The EU acne market is projected to grow substantially, driven by high acne prevalence among young populations.
• Challenges Ahead: Maintaining clinician and patient interest and ensuring patient compliance are critical for long-term success.

FAQs

What is Winlevi and how does it work?

Winlevi, or clascoterone cream 1%, is a topical acne treatment with a novel antiandrogen mechanism of action, approved for patients 12 years and older.

Who has the exclusive rights to commercialize Winlevi in the U.S. and Canada?

Sun Pharma has the exclusive rights to commercialize Winlevi in the U.S. and Canada[3].

What are the financial projections for Winlevi in the U.S.?

Winlevi has a peak sales forecast of $419 million in the U.S., according to analyst reports[4].

How has Cosmo Pharmaceuticals' financial performance been impacted by Winlevi?

Cosmo Pharmaceuticals has seen a significant increase in revenue and profit, driven largely by the success of Winlevi, with revenue soaring to €136.2 million in the first half of 2024[2].

What are the potential challenges for Winlevi's long-term success?

Potential challenges include maintaining clinician and patient interest if real-world data does not match clinical trial results, and ensuring patient compliance with the topical treatment[4].

Sources

1. PR Newswire: Cosmo and Glenmark announce the signing of Distribution and License Agreements for Winlevi in Europe and South Africa.
2. Stock Titan: Cosmo Achieves Robust Financial Performance in H1 2024 and Confirms Guidance.
3. Economic Times: Sun Pharma gets exclusive right to commercialise Winlevi acne cream in US, Canada.
4. Clinical Trials Arena: Cassiopea's Winlevi uptake in acne driven by new mechanism, though interest to wane.
5. Cosmo Pharmaceuticals: Cosmo Presents Strong H1 2023 Operational and Financial Results.