Clascoterone Patent Expiration

Clascoterone is Used for treating acne vulgaris. It was first introduced by Sun Pharmaceutical Industries Ltd in its drug Winlevi on Aug 26, 2020.


Clascoterone Patents

Given below is the list of patents protecting Clascoterone, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Winlevi US8785427 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives Jul 25, 2030 Sun Pharm
Winlevi US9433628 Enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives Feb 28, 2029 Sun Pharm
Winlevi US11207332 Enzymatic process for obtaining 17 α-monoesters of cortexolone and/or its 9,11-dehydroderivatives Nov 20, 2028 Sun Pharm
Winlevi US10159682 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives Aug 14, 2028 Sun Pharm
Winlevi US11938141 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives Jul 24, 2028 Sun Pharm
Winlevi US9486458 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives Jul 24, 2028 Sun Pharm
Winlevi US8865690 17alfa, 21-dihydroxypregnene esters as antiandrogenic agents Jul 24, 2025 Sun Pharm
Winlevi US9211295 17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents May 31, 2025 Sun Pharm
Winlevi US8143240 17α, 21-dihydroxypregnene esters as antiandrogenic agents Jan 12, 2025 Sun Pharm



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Clascoterone's patents.

Given below is the list recent legal activities going on the following patents of Clascoterone.

Activity Date Patent Number
Patent litigations
Interim Patent Term Extension Granted 22 May, 2024 US8865690
Interim Patent Term Extension Granted 22 May, 2024 US9211295
Payment of Maintenance Fee, 8th Year, Large Entity 08 May, 2024 US9486458
Payment of Maintenance Fee, 8th Year, Large Entity 06 Mar, 2024 US9433628
transaction for FDA Determination of Regulatory Review Period 14 Feb, 2024 US9433628
transaction for FDA Determination of Regulatory Review Period 14 Feb, 2024 US9486458
transaction for FDA Determination of Regulatory Review Period 14 Feb, 2024 US9211295
transaction for FDA Determination of Regulatory Review Period 14 Feb, 2024 US8865690
transaction for FDA Determination of Regulatory Review Period 14 Feb, 2024 US8143240
transaction for FDA Determination of Regulatory Review Period 14 Feb, 2024 US8785427


Clascoterone's Family Patents

Family Patents

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