Clascoterone - Generic Drug Details

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What are the generic drug sources for clascoterone and what is the scope of freedom to operate?

Clascoterone is the generic ingredient in one branded drug marketed by Sun Pharm and is included in one NDA. There are nine 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:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	4
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^: ⤷ Subscribe* 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.

Recent Clinical Trials for clascoterone

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

Sponsor	Phase
Chang Gung Memorial Hospital	Phase 1/Phase 2
Ergomed PLC	Phase 3
Pharmapace Inc	Phase 3

See all clascoterone clinical trials

Pharmacology for clascoterone

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for clascoterone

D10AX	Other anti-acne preparations for topical use
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for CLASCOTERONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
WINLEVI	Cream	clascoterone	1%	213433	1	2024-08-26

US Patents and Regulatory Information for clascoterone

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Glossary

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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	11,938,141	⤷ Subscribe	Y			⤷ Subscribe
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes	8,785,427	⤷ Subscribe	Y			⤷ Subscribe
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes	9,211,295	⤷ Subscribe	Y			⤷ Subscribe
Sun Pharm	WINLEVI	clascoterone	CREAM;TOPICAL	213433-001	Aug 26, 2020		RX	Yes	Yes	9,433,628	⤷ Subscribe	Y			⤷ Subscribe
>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

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Country	Patent Number	Title	Estimated Expiration
Japan	2005504762		⤷ Subscribe
Canada	2871025	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)	⤷ Subscribe
Canada	2691445	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)	⤷ Subscribe
European Patent Office	1421099	ESTERS DE 17ALFA, 21-DIHYDROXYPREGNENE UTILISES COMME AGENTS ANTIANDROGENES (17ALFA, 21-DIHYDROXYPREGNENE ESTERS AS ANTIANDROGENIC AGENTS)	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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