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 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
*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 |
| ICON Clinical Research | Phase 3 |
| Stanford University | Phase 1/Phase 2 |
Pharmacology for clascoterone
| Drug Class | Androgen Receptor Inhibitor |
| Mechanism of Action | Androgen Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for clascoterone
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433-001 | Aug 26, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
|---|---|---|---|
| South Korea | 101495192 | ⤷ Sign Up | |
| South Africa | 201100133 | ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES | ⤷ Sign Up |
| Slovenia | 2503005 | ⤷ Sign Up | |
| Spain | 2554934 | ⤷ Sign Up | |
| South Korea | 20100044845 | ENZYMATIC PROCESS FOR OBTAINING 17 ALPHA-MONOESTERS OF CORTEXOLONE AND/OR ITS 9,11-DEHYDRODERIVATIVES | ⤷ Sign Up |
| Canada | 2454675 | ESTERS DE 17ALFA, 21-DIHYDROXYPREGNENE UTILISES COMME AGENTSANTIANDROGENES (17ALFA, 21-DIHYDROXYPREGNENE ESTERS AS ANTIANDROGENIC AGENTS) | ⤷ Sign Up |
| Slovenia | 2966175 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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