Winlevi is a drug owned by Sun Pharmaceutical Industries Ltd. It is protected by 9 US drug patents filed from 2020 to 2024 out of which none have expired yet. Winlevi's patents have been open to challenges since 26 August, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 25, 2030. Details of Winlevi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8785427 | Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives |
Jul, 2030
(5 years from now) | Active |
| US9433628 | Enzymatic process for obtaining 17α-monoesters of cortexolone and/or its 9,11-dehydroderivatives |
Feb, 2029
(3 years from now) | Active |
| US11207332 | Enzymatic process for obtaining 17 α-monoesters of cortexolone and/or its 9,11-dehydroderivatives |
Nov, 2028
(3 years from now) | Active |
| US10159682 | Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives |
Aug, 2028
(3 years from now) | Active |
| US9486458 | Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives |
Jul, 2028
(3 years from now) | Active |
| US11938141 | Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives |
Jul, 2028
(3 years from now) | Active |
| US8143240 | 17α, 21-dihydroxypregnene esters as antiandrogenic agents |
Jan, 2026
(8 months from now) | Active |
| US8865690 | 17alfa, 21-dihydroxypregnene esters as antiandrogenic agents |
Jul, 2025
(2 months from now) | Active |
| US9211295 | 17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents |
May, 2025
(18 days from now) | Active |
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 Winlevi's patents.
Latest Legal Activities on Winlevi's Patents
Given below is the list of recent legal activities going on the following patents of Winlevi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Interim Patent Term Extension Granted Critical | 22 May, 2024 | US8865690 |
| Interim Patent Term Extension Granted Critical | 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 |
FDA has granted several exclusivities to Winlevi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Winlevi, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Winlevi.
Exclusivity Information
Winlevi holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Winlevi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 26, 2025 |
US patents provide insights into the exclusivity only within the United States, but Winlevi is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Winlevi's family patents as well as insights into ongoing legal events on those patents.
Winlevi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Winlevi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 25, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Winlevi Generics:
There are no approved generic versions for Winlevi as of now.
About Winlevi
Winlevi is a drug owned by Sun Pharmaceutical Industries Ltd. It is used for treating acne vulgaris. Winlevi uses Clascoterone as an active ingredient. Winlevi was launched by Sun Pharm in 2020.
Approval Date:
Winlevi was approved by FDA for market use on 26 August, 2020.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Winlevi is 26 August, 2020, its NCE-1 date is estimated to be 26 August, 2024.
Active Ingredient:
Winlevi uses Clascoterone as the active ingredient. Check out other Drugs and Companies using Clascoterone ingredient
Treatment:
Winlevi is used for treating acne vulgaris.
Dosage:
Winlevi is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1% | CREAM | Prescription | TOPICAL |