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Last Updated: April 19, 2024

Clascoterone - Generic Drug Details


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What are the generic sources for clascoterone and what is the scope of patent protection?

Clascoterone is the generic ingredient in one branded drug marketed by Sun Pharm and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Clascoterone has eighty-nine patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for clascoterone
International Patents:89
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 51
Clinical Trials: 3
Patent Applications: 145
What excipients (inactive ingredients) are in clascoterone?clascoterone excipients list
DailyMed Link:clascoterone at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for clascoterone
Generic Entry Date for clascoterone*:
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.

Recent Clinical Trials for clascoterone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Pharmapace IncPhase 3
Canfield Scientific Inc.Phase 3
ICON Clinical ResearchPhase 3

See all clascoterone clinical trials

Pharmacology for clascoterone

US Patents and Regulatory Information for clascoterone

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 ⤷  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 ⤷  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
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 clascoterone

Country Patent Number Title Estimated Expiration
Canada 2871039 PROCEDE ENZYMATIQUE POUR OBTENIR DES 17 ALPHA-MONOESTERS DE CORTEXOLONE ET/OU SES DERIVES 9,11-DESHYDRO (ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES) ⤷  Try a Trial
New Zealand 599437 Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives. ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 03014141 ⤷  Try a Trial
Croatia P20151174 ⤷  Try a Trial
Poland 2503004 ⤷  Try a Trial
European Patent Office 2966175 COMPOSITIONS PHARMACEUTIQUES COMPRENANT DU CORTEXOLONE-17-ALPHA-PROPIONATE (PHARMACEUTICAL COMPOSITIONS CONTAINING CORTEXOLONE-17-ALPHA-PROPIONATE) ⤷  Try a Trial
European Patent Office 2173891 Procédé enzymatique pour obtenir le 17-alpha-propionate de cortexolone en forme cristalline III (Enzymatic process for obtaining cortexolone-17-alpha-propionate in crystalline form III) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated 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. 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.