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
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 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes 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 | |||
>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 |
---|---|---|---|
Germany | 60203013 | ⤷ Try a Trial | |
Lithuania | 2966175 | ⤷ Try a Trial | |
Argentina | 111351 | 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 | ⤷ Try a Trial |
Japan | 6108944 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |