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Last Updated: March 5, 2024

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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  Try a Trial

Summary for WINLEVI
International Patents:89
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 51
Patent Applications: 97
Drug Prices: Drug price information for WINLEVI
What excipients (inactive ingredients) are in WINLEVI?WINLEVI excipients list
DailyMed Link:WINLEVI at DailyMed
Drug patent expirations by year for WINLEVI
Drug Prices for WINLEVI

See drug prices for WINLEVI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17ALPHA-PROPIONATE

17.alpha., 21-dihydroxypregnene esters as antiandrogenic agents
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

17alfa, 21-dihydroxypregnene esters as antiandrogenic agents
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE

17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Enzymatic process for obtaining 17.alpha.-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

FDA Regulatory Exclusivity protecting WINLEVI

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sun Pharm WINLEVI clascoterone CREAM;TOPICAL 213433-001 Aug 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sun Pharm WINLEVI clascoterone CREAM;TOPICAL 213433-001 Aug 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm WINLEVI clascoterone CREAM;TOPICAL 213433-001 Aug 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sun Pharm WINLEVI clascoterone CREAM;TOPICAL 213433-001 Aug 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 1202
Estimated Expiration: ⤷  Try a Trial

Patent: 1351
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 08285784
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0814163
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 91445
Estimated Expiration: ⤷  Try a Trial

Patent: 71025
Estimated Expiration: ⤷  Try a Trial

Patent: 71039
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1743316
Estimated Expiration: ⤷  Try a Trial

Patent: 3450304
Estimated Expiration: ⤷  Try a Trial

Patent: 4861023
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0140421
Estimated Expiration: ⤷  Try a Trial

Patent: 0151174
Estimated Expiration: ⤷  Try a Trial

Patent: 0151298
Estimated Expiration: ⤷  Try a Trial

Patent: 0191143
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 73891
Estimated Expiration: ⤷  Try a Trial

Patent: 03004
Estimated Expiration: ⤷  Try a Trial

Patent: 03005
Estimated Expiration: ⤷  Try a Trial

Patent: 66175
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 73891
Estimated Expiration: ⤷  Try a Trial

Patent: 03004
Estimated Expiration: ⤷  Try a Trial

Patent: 03005
Estimated Expiration: ⤷  Try a Trial

Patent: 66175
Estimated Expiration: ⤷  Try a Trial

Patent: 21298
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 26206
Estimated Expiration: ⤷  Try a Trial

Patent: 26507
Estimated Expiration: ⤷  Try a Trial

Patent: 44237
Estimated Expiration: ⤷  Try a Trial

Italy

Patent: 20071616
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 46992
Estimated Expiration: ⤷  Try a Trial

Patent: 08944
Estimated Expiration: ⤷  Try a Trial

Patent: 74645
Estimated Expiration: ⤷  Try a Trial

Patent: 10535173
Estimated Expiration: ⤷  Try a Trial

Patent: 13163683
Estimated Expiration: ⤷  Try a Trial

Patent: 16014045
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 66175
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 3238
Estimated Expiration: ⤷  Try a Trial

Patent: 3701
Estimated Expiration: ⤷  Try a Trial

Patent: 10001256
Estimated Expiration: ⤷  Try a Trial

Patent: 19003639
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9437
Estimated Expiration: ⤷  Try a Trial

Patent: 0767
Estimated Expiration: ⤷  Try a Trial

Patent: 5953
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 73891
Estimated Expiration: ⤷  Try a Trial

Patent: 03004
Estimated Expiration: ⤷  Try a Trial

Patent: 03005
Estimated Expiration: ⤷  Try a Trial

Patent: 66175
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 73891
Estimated Expiration: ⤷  Try a Trial

Patent: 03004
Estimated Expiration: ⤷  Try a Trial

Patent: 03005
Estimated Expiration: ⤷  Try a Trial

Patent: 66175
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 82190
Estimated Expiration: ⤷  Try a Trial

Patent: 99452
Estimated Expiration: ⤷  Try a Trial

Patent: 10107599
Estimated Expiration: ⤷  Try a Trial

Patent: 12113839
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 310
Estimated Expiration: ⤷  Try a Trial

Patent: 354
Estimated Expiration: ⤷  Try a Trial

Patent: 361
Estimated Expiration: ⤷  Try a Trial

Patent: 950
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 73891
Estimated Expiration: ⤷  Try a Trial

Patent: 03004
Estimated Expiration: ⤷  Try a Trial

Patent: 03005
Estimated Expiration: ⤷  Try a Trial

Patent: 66175
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1000587
Estimated Expiration: ⤷  Try a Trial

Patent: 1100133
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1495192
Estimated Expiration: ⤷  Try a Trial

Patent: 100044845
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 62946
Estimated Expiration: ⤷  Try a Trial

Patent: 51910
Estimated Expiration: ⤷  Try a Trial

Patent: 54934
Estimated Expiration: ⤷  Try a Trial

Patent: 32326
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1909129
Estimated Expiration: ⤷  Try a Trial

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
Slovenia 2503005 ⤷  Try a Trial
New Zealand 615953 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives ⤷  Try a Trial
Austria 289318 ⤷  Try a Trial
Italy MI20011762 ⤷  Try a Trial
Mexico 2010001256 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.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.