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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 213433

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NDA 213433 describes WINLEVI, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the WINLEVI profile page.

The generic ingredient in WINLEVI is clascoterone. One supplier is listed for this compound. Additional details are available on the clascoterone profile page.

Summary for 213433

Tradename:	WINLEVI
Applicant:	Sun Pharm
Ingredient:	clascoterone
Patents:	10

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213433

Generic Entry Date for 213433^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: 8,785,427 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 NDA: 213433

Mechanism of Action	Androgen Receptor Antagonists

Suppliers and Packaging for NDA: 213433

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
WINLEVI	clascoterone	CREAM;TOPICAL	213433	NDA	Sun Pharmaceutical Industries, Inc.	47335-994	47335-994-36	1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE
WINLEVI	clascoterone	CREAM;TOPICAL	213433	NDA	Sun Pharmaceutical Industries, Inc.	47335-994	47335-994-94	12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Aug 26, 2020	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 26, 2025
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	10,159,682	Patent Expiration:	Aug 14, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE
Patent:	11,207,332	Patent Expiration:	Nov 20, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17ALPHA-PROPIONATE

Expired US Patents for NDA 213433

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020	9,211,295	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.