WINLEVI Drug Patent Profile
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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
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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: | 82 |
| Drug Prices: | Drug price information for WINLEVI |
| What excipients (inactive ingredients) are in WINLEVI? | WINLEVI excipients list |
| DailyMed Link: | WINLEVI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for WINLEVI
*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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of WINLEVI is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17ALPHA-PROPIONATE
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
17.alpha., 21-dihydroxypregnene esters as antiandrogenic agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
17alfa, 21-dihydroxypregnene esters as antiandrogenic agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE
17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enzymatic process for obtaining 17.alpha.-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE
FDA Regulatory Exclusivity protecting WINLEVI
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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
Patent: PROCESO ENZIMATICO PARA OBTENER 17-ALFA MONOESTERES DE CORTEXOLONA Y/O SUS 9,11-DEHIDRO DERIVADOS
Estimated Expiration: ⤷ Sign Up
Patent: 1202
Patent: FORMAS CRISTALINAS DE CORTEXOLONA
Estimated Expiration: ⤷ Sign Up
Patent: 1351
Patent: FORMA CRISTALINA I DEL 17-a-PROPIONATO DE CORTEXOLONA, COMPOSICIÓN FARMACÉUTICA QUE LA CONTIENE Y SU EMPLEO EN EL TRATAMIENTO DE UNA PATOLOGÍA RELACIONADA CON EL APARATO UROGENITAL, ENDÓCRINO O DE LA PIEL Y/O ANEXOS DE ÉSTA
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 08285784
Patent: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0814163
Patent: PROCESSO PARA A PREPARAÇÃO DE COMPOSTOS, FORMA CRISTALINA, E, COMPOSIÇÃO FARMACÊUTICA
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 91445
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Patent: 71025
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Patent: 71039
Patent: 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)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1743316
Patent: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Estimated Expiration: ⤷ Sign Up
Patent: 3450304
Patent: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Estimated Expiration: ⤷ Sign Up
Patent: 4861023
Patent: Enzymatic Process For Obtaining 17 Alpha-monoesters Of Cortexolone And/or Its 9,11-dehydroderivatives
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0140421
Estimated Expiration: ⤷ Sign Up
Patent: 0151174
Estimated Expiration: ⤷ Sign Up
Patent: 0151298
Estimated Expiration: ⤷ Sign Up
Patent: 0191143
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 73891
Estimated Expiration: ⤷ Sign Up
Patent: 03004
Estimated Expiration: ⤷ Sign Up
Patent: 03005
Estimated Expiration: ⤷ Sign Up
Patent: 66175
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 73891
Patent: Procédé enzymatique pour obtenir le 17-alpha-propionate de cortexolone en forme cristalline III (Enzymatic process for obtaining cortexolone-17-alpha-propionate in crystalline form III)
Estimated Expiration: ⤷ Sign Up
Patent: 03004
Patent: Cortexolone-17alpha-propionate sous forme cristalline I (Cortexolone-17alpha-propionate in crystalline form I)
Estimated Expiration: ⤷ Sign Up
Patent: 03005
Patent: Cortexolone-17alpha-propionate sous forme cristalline d'hydrate IV (Cortexolone-17alpha-propionate in hydrate crystalline form IV)
Estimated Expiration: ⤷ Sign Up
Patent: 66175
Patent: COMPOSITIONS PHARMACEUTIQUES COMPRENANT DU CORTEXOLONE-17-ALPHA-PROPIONATE (PHARMACEUTICAL COMPOSITIONS CONTAINING CORTEXOLONE-17-ALPHA-PROPIONATE)
Estimated Expiration: ⤷ Sign Up
Patent: 21298
Patent: FORME CRISTALLINE III DE CORTEXOLONE-17-ALPHA-PROPIONATE ET SON UTILISATION PHARMACEUTIQUE (CORTEXOLONE-17-ALPHA-PROPIONATE CRYSTALLINE FORM III AND ITS PHARMACEUTICAL USE)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 26206
Estimated Expiration: ⤷ Sign Up
Patent: 26507
Estimated Expiration: ⤷ Sign Up
Patent: 44237
Estimated Expiration: ⤷ Sign Up
Italy
Patent: 20071616
Patent: PROCESSO ENZIMATICO PER L'OTTENIMENTO DI 17-ALFA MONOESTERI DEL CORTEXOLONE E/O SUOI 9,11-DEIDRODERIVATI.
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 46992
Estimated Expiration: ⤷ Sign Up
Patent: 08944
Estimated Expiration: ⤷ Sign Up
Patent: 74645
Estimated Expiration: ⤷ Sign Up
Patent: 10535173
Estimated Expiration: ⤷ Sign Up
Patent: 13163683
Patent: ENZYMATIC PROCESS FOR OBTAINING 17α-MONOESTER OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVE
Estimated Expiration: ⤷ Sign Up
Patent: 16014045
Patent: コルテキソロンの１７α−モノエステルおよび／またはその９，１１−デヒドロ誘導体を得るための酵素的方法 (ENZYMATIC PROCESS FOR OBTAINING 17α-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRO DERIVATIVES)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 66175
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 3238
Patent: 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.)
Estimated Expiration: ⤷ Sign Up
Patent: 3701
Patent: 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.)
Estimated Expiration: ⤷ Sign Up
Patent: 10001256
Patent: 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.)
Estimated Expiration: ⤷ Sign Up
Patent: 19003639
Patent: 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.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 9437
Patent: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives.
Estimated Expiration: ⤷ Sign Up
Patent: 0767
Patent: ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES
Estimated Expiration: ⤷ Sign Up
Patent: 5953
Patent: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 73891
Estimated Expiration: ⤷ Sign Up
Patent: 03004
Estimated Expiration: ⤷ Sign Up
Patent: 03005
Estimated Expiration: ⤷ Sign Up
Patent: 66175
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 73891
Estimated Expiration: ⤷ Sign Up
Patent: 03004
Estimated Expiration: ⤷ Sign Up
Patent: 03005
Estimated Expiration: ⤷ Sign Up
Patent: 66175
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 82190
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ КОРТЕКСОЛОН-17α-ПРОПИОНАТА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (CRYSTALLINE FORMS OF CORTEXOLONE-17?-PROPIONATE AND METHOD FOR PREPARING THEM)
Estimated Expiration: ⤷ Sign Up
Patent: 99452
Patent: КРИСТАЛЛИЧЕСКАЯ СОЛЬВАТНАЯ ФОРМА КОРТЕКСОЛОН-17альфа-ПРОПИОНАТА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ НА ЕЕ ОСНОВЕ (CRYSTALLINE SOLVATE FORM OF CORTEXOLONE-17alpha-PROPIONATE, A PREPARATION METHOD THEREOF AND A PHARMACEUTICAL COMPOSITION BASED THEREON)
Estimated Expiration: ⤷ Sign Up
Patent: 10107599
Patent: ФЕРМЕНТАТИВНЫЙ СПОСОБ ПОЛУЧЕНИЯ 17-МОНОЭФИРОВ КОРТЕКСОЛОНА И/ИЛИ ИХ 9,11-ДЕГИДРОПРОИЗВОДНЫХ
Estimated Expiration: ⤷ Sign Up
Patent: 12113839
Patent: КРИСТАЛЛИЧЕСКАЯ СОЛЬВАТНАЯ ФОРМА КОРТЕКСОЛОН-17АЛЬФА-ПРОПИОНАТА И СПОСОБ ЕЕ ПОЛУЧЕНИЯ
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 310
Patent: ENZIMATSKI POSTUPAK ZA DOBIJANJE KORTEKSOLON-17-ALFA-PROPIONATA U KRISTALNOM OBLIKU III (ENZYMATIC PROCESS FOR OBTAINING CORTEXOLONE-17-ALPHA-PROPIONATE IN CRYSTALLINE FORM III)
Estimated Expiration: ⤷ Sign Up
Patent: 354
Patent: KORTEKSOLON-17ALFA-PROPIONAT U KRISTALNOM OBLIKU I (CORTEXOLONE-17ALPHA-PROPIONATE IN CRYSTALLINE FORM I)
Estimated Expiration: ⤷ Sign Up
Patent: 361
Patent: KORTEKSOLON-17ALFA-PROPIONAT U KRISTALNOM HIDRATNOM OBLIKU IV (CORTEXOLONE-17ALPHA-PROPIONATE IN HYDRATE CRYSTALLINE FORM IV)
Estimated Expiration: ⤷ Sign Up
Patent: 950
Patent: FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE KORTEKSOLON-17-ALFA-PROPIONAT (PHARMACEUTICAL COMPOSITIONS CONTAINING CORTEXOLONE-17-ALPHA-PROPIONATE)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 73891
Estimated Expiration: ⤷ Sign Up
Patent: 03004
Estimated Expiration: ⤷ Sign Up
Patent: 03005
Estimated Expiration: ⤷ Sign Up
Patent: 66175
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1000587
Patent: ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES
Estimated Expiration: ⤷ Sign Up
Patent: 1100133
Patent: ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1495192
Estimated Expiration: ⤷ Sign Up
Patent: 100044845
Patent: ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 62946
Estimated Expiration: ⤷ Sign Up
Patent: 51910
Estimated Expiration: ⤷ Sign Up
Patent: 54934
Estimated Expiration: ⤷ Sign Up
Patent: 32326
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1909129
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| South Korea | 101495192 | ⤷ Sign Up | |
| South Africa | 201100133 | ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES | ⤷ Sign Up |
| Slovenia | 2503005 | ⤷ Sign Up | |
| Spain | 2554934 | ⤷ Sign Up | |
| South Korea | 20100044845 | ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES | ⤷ Sign Up |
| >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.
ISSN: 2162-2639
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