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Last Updated: December 24, 2024

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 nine 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:9
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213433
Generic Entry Date for 213433*:
Constraining patent/regulatory exclusivity:
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 ActionAndrogen 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:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Aug 26, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 26, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:10,159,682Patent Expiration:Aug 14, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE
Patent:11,207,332Patent Expiration:Nov 20, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17ALPHA-PROPIONATE

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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. 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.