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Last Updated: February 7, 2023

WINLEVI Drug Patent Profile


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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.

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 will be eligible for patent challenges on August 26, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for WINLEVI
International Patents:89
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 48
Patent Applications: 93
What excipients (inactive ingredients) are in WINLEVI?WINLEVI excipients list
DailyMed Link:WINLEVI at DailyMed
Drug patent expirations by year for WINLEVI
DrugPatentWatch® Estimated Generic Entry Opportunity Date for WINLEVI
Generic Entry Date for WINLEVI*:
Constraining patent/regulatory exclusivity:
NDA:
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

US Patents and Regulatory Information for WINLEVI

WINLEVI is protected by eight US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of WINLEVI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting WINLEVI

Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE

Enzymatic process for obtaining 17 .alpha.-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17ALPHA-PROPIONATE

17.alpha., 21-dihydroxypregnene esters as antiandrogenic agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE

Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

17alfa, 21-dihydroxypregnene esters as antiandrogenic agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE

17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Enzymatic process for obtaining 17.alpha.-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE

FDA Regulatory Exclusivity protecting WINLEVI

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm WINLEVI clascoterone CREAM;TOPICAL 213433-001 Aug 26, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sun Pharm WINLEVI clascoterone CREAM;TOPICAL 213433-001 Aug 26, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm WINLEVI clascoterone CREAM;TOPICAL 213433-001 Aug 26, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm WINLEVI clascoterone CREAM;TOPICAL 213433-001 Aug 26, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 2235
Estimated Expiration: See Plans and Pricing

Patent: 1202
Estimated Expiration: See Plans and Pricing

Patent: 1351
Estimated Expiration: See Plans and Pricing

Australia

Patent: 08285784
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0814163
Estimated Expiration: See Plans and Pricing

Canada

Patent: 91445
Estimated Expiration: See Plans and Pricing

Patent: 71025
Estimated Expiration: See Plans and Pricing

Patent: 71039
Estimated Expiration: See Plans and Pricing

China

Patent: 1743316
Estimated Expiration: See Plans and Pricing

Patent: 3450304
Estimated Expiration: See Plans and Pricing

Patent: 4861023
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0140421
Estimated Expiration: See Plans and Pricing

Patent: 0151174
Estimated Expiration: See Plans and Pricing

Patent: 0151298
Estimated Expiration: See Plans and Pricing

Patent: 0191143
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 73891
Estimated Expiration: See Plans and Pricing

Patent: 03004
Estimated Expiration: See Plans and Pricing

Patent: 03005
Estimated Expiration: See Plans and Pricing

Patent: 66175
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 73891
Estimated Expiration: See Plans and Pricing

Patent: 03004
Estimated Expiration: See Plans and Pricing

Patent: 03005
Estimated Expiration: See Plans and Pricing

Patent: 66175
Estimated Expiration: See Plans and Pricing

Patent: 21298
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 26206
Estimated Expiration: See Plans and Pricing

Patent: 26507
Estimated Expiration: See Plans and Pricing

Patent: 44237
Estimated Expiration: See Plans and Pricing

Italy

Patent: 20071616
Estimated Expiration: See Plans and Pricing

Japan

Patent: 46992
Estimated Expiration: See Plans and Pricing

Patent: 08944
Estimated Expiration: See Plans and Pricing

Patent: 74645
Estimated Expiration: See Plans and Pricing

Patent: 10535173
Estimated Expiration: See Plans and Pricing

Patent: 13163683
Estimated Expiration: See Plans and Pricing

Patent: 16014045
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 66175
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 3238
Estimated Expiration: See Plans and Pricing

Patent: 3701
Estimated Expiration: See Plans and Pricing

Patent: 10001256
Estimated Expiration: See Plans and Pricing

Patent: 19003639
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9437
Estimated Expiration: See Plans and Pricing

Patent: 0767
Estimated Expiration: See Plans and Pricing

Patent: 5953
Estimated Expiration: See Plans and Pricing

Poland

Patent: 73891
Estimated Expiration: See Plans and Pricing

Patent: 03004
Estimated Expiration: See Plans and Pricing

Patent: 03005
Estimated Expiration: See Plans and Pricing

Patent: 66175
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 73891
Estimated Expiration: See Plans and Pricing

Patent: 03004
Estimated Expiration: See Plans and Pricing

Patent: 03005
Estimated Expiration: See Plans and Pricing

Patent: 66175
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 82190
Estimated Expiration: See Plans and Pricing

Patent: 99452
Estimated Expiration: See Plans and Pricing

Patent: 10107599
Estimated Expiration: See Plans and Pricing

Patent: 12113839
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 310
Estimated Expiration: See Plans and Pricing

Patent: 354
Estimated Expiration: See Plans and Pricing

Patent: 361
Estimated Expiration: See Plans and Pricing

Patent: 950
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 73891
Estimated Expiration: See Plans and Pricing

Patent: 03004
Estimated Expiration: See Plans and Pricing

Patent: 03005
Estimated Expiration: See Plans and Pricing

Patent: 66175
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1000587
Estimated Expiration: See Plans and Pricing

Patent: 1100133
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1495192
Estimated Expiration: See Plans and Pricing

Patent: 100044845
Estimated Expiration: See Plans and Pricing

Spain

Patent: 62946
Estimated Expiration: See Plans and Pricing

Patent: 51910
Estimated Expiration: See Plans and Pricing

Patent: 54934
Estimated Expiration: See Plans and Pricing

Patent: 32326
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1909129
Estimated Expiration: See Plans and Pricing

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
Spain 2462946 See Plans and Pricing
European Patent Office 3521298 FORME CRISTALLINE III DE CORTEXOLONE-17-ALPHA-PROPIONATE ET SON UTILISATION PHARMACEUTIQUE (CORTEXOLONE-17-ALPHA-PROPIONATE CRYSTALLINE FORM III AND ITS PHARMACEUTICAL USE) See Plans and Pricing
Poland 2503005 See Plans and Pricing
New Zealand 615953 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives See Plans and Pricing
Croatia P20151174 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.