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 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: | 88 |
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
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
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 ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
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 | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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: ⤷ Subscribe
Patent: 1202
Patent: FORMAS CRISTALINAS DE CORTEXOLONA
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Australia
Patent: 08285784
Patent: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0814163
Patent: PROCESSO PARA A PREPARAÇÃO DE COMPOSTOS, FORMA CRISTALINA, E, COMPOSIÇÃO FARMACÊUTICA
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
China
Patent: 1743316
Patent: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Estimated Expiration: ⤷ Subscribe
Patent: 3450304
Patent: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Estimated Expiration: ⤷ Subscribe
Patent: 4861023
Patent: Enzymatic Process For Obtaining 17 Alpha-monoesters Of Cortexolone And/or Its 9,11-dehydroderivatives
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0140421
Estimated Expiration: ⤷ Subscribe
Patent: 0151174
Estimated Expiration: ⤷ Subscribe
Patent: 0151298
Estimated Expiration: ⤷ Subscribe
Patent: 0191143
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 73891
Estimated Expiration: ⤷ Subscribe
Patent: 03004
Estimated Expiration: ⤷ Subscribe
Patent: 03005
Estimated Expiration: ⤷ Subscribe
Patent: 66175
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent: 03004
Patent: Cortexolone-17alpha-propionate sous forme cristalline I (Cortexolone-17alpha-propionate in crystalline form I)
Estimated Expiration: ⤷ Subscribe
Patent: 03005
Patent: Cortexolone-17alpha-propionate sous forme cristalline d'hydrate IV (Cortexolone-17alpha-propionate in hydrate crystalline form IV)
Estimated Expiration: ⤷ Subscribe
Patent: 66175
Patent: COMPOSITIONS PHARMACEUTIQUES COMPRENANT DU CORTEXOLONE-17-ALPHA-PROPIONATE (PHARMACEUTICAL COMPOSITIONS CONTAINING CORTEXOLONE-17-ALPHA-PROPIONATE)
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Hungary
Patent: 26206
Estimated Expiration: ⤷ Subscribe
Patent: 26507
Estimated Expiration: ⤷ Subscribe
Patent: 44237
Estimated Expiration: ⤷ Subscribe
Italy
Patent: 20071616
Patent: PROCESSO ENZIMATICO PER L'OTTENIMENTO DI 17-ALFA MONOESTERI DEL CORTEXOLONE E/O SUOI 9,11-DEIDRODERIVATI.
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 46992
Estimated Expiration: ⤷ Subscribe
Patent: 08944
Estimated Expiration: ⤷ Subscribe
Patent: 74645
Estimated Expiration: ⤷ Subscribe
Patent: 10535173
Estimated Expiration: ⤷ Subscribe
Patent: 13163683
Patent: ENZYMATIC PROCESS FOR OBTAINING 17α-MONOESTER OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVE
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Lithuania
Patent: 66175
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
New Zealand
Patent: 9437
Patent: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives.
Estimated Expiration: ⤷ Subscribe
Patent: 0767
Patent: ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES
Estimated Expiration: ⤷ Subscribe
Patent: 5953
Patent: Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 73891
Estimated Expiration: ⤷ Subscribe
Patent: 03004
Estimated Expiration: ⤷ Subscribe
Patent: 03005
Estimated Expiration: ⤷ Subscribe
Patent: 66175
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 73891
Estimated Expiration: ⤷ Subscribe
Patent: 03004
Estimated Expiration: ⤷ Subscribe
Patent: 03005
Estimated Expiration: ⤷ Subscribe
Patent: 66175
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Patent: 10107599
Patent: ФЕРМЕНТАТИВНЫЙ СПОСОБ ПОЛУЧЕНИЯ 17-МОНОЭФИРОВ КОРТЕКСОЛОНА И/ИЛИ ИХ 9,11-ДЕГИДРОПРОИЗВОДНЫХ
Estimated Expiration: ⤷ Subscribe
Patent: 12113839
Patent: КРИСТАЛЛИЧЕСКАЯ СОЛЬВАТНАЯ ФОРМА КОРТЕКСОЛОН-17АЛЬФА-ПРОПИОНАТА И СПОСОБ ЕЕ ПОЛУЧЕНИЯ
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent: 354
Patent: KORTEKSOLON-17ALFA-PROPIONAT U KRISTALNOM OBLIKU I (CORTEXOLONE-17ALPHA-PROPIONATE IN CRYSTALLINE FORM I)
Estimated Expiration: ⤷ Subscribe
Patent: 361
Patent: KORTEKSOLON-17ALFA-PROPIONAT U KRISTALNOM HIDRATNOM OBLIKU IV (CORTEXOLONE-17ALPHA-PROPIONATE IN HYDRATE CRYSTALLINE FORM IV)
Estimated Expiration: ⤷ Subscribe
Patent: 950
Patent: FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE KORTEKSOLON-17-ALFA-PROPIONAT (PHARMACEUTICAL COMPOSITIONS CONTAINING CORTEXOLONE-17-ALPHA-PROPIONATE)
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 73891
Estimated Expiration: ⤷ Subscribe
Patent: 03004
Estimated Expiration: ⤷ Subscribe
Patent: 03005
Estimated Expiration: ⤷ Subscribe
Patent: 66175
Estimated Expiration: ⤷ Subscribe
South Africa
Patent: 1000587
Patent: ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES
Estimated Expiration: ⤷ Subscribe
Patent: 1100133
Patent: ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1495192
Estimated Expiration: ⤷ Subscribe
Patent: 100044845
Patent: ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 62946
Estimated Expiration: ⤷ Subscribe
Patent: 51910
Estimated Expiration: ⤷ Subscribe
Patent: 54934
Estimated Expiration: ⤷ Subscribe
Patent: 32326
Estimated Expiration: ⤷ Subscribe
Turkey
Patent: 1909129
Estimated Expiration: ⤷ Subscribe
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 | ⤷ Subscribe |
Russian Federation | 2482190 | ⤷ Subscribe | |
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) | ⤷ Subscribe |
New Zealand | 599437 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
WINLEVI Market Analysis and Financial Projection Experimental
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