NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as SUN PHARM. It is marketed under 1 brand name, including WINLEVI. Available in 1 different strength, such as 1%, and administered through 1 route including CREAM;TOPICAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
|---|
Patents approved by the FDA for the ingredient
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|
Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"55437","ingredient":"CLASCOTERONE","trade_name":"WINLEVI","family_id":"c7936e5861964962ac18","publication_number":"US9211295B2","cleaned_patent_number":"9211295","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-05-31","publication_date":"2015-12-15","legal_status":"Expired"} | US9211295B2 Formulation | 15 Dec, 2015 | Expired | 31 May, 2025 | |
| {"application_id":"55436","ingredient":"CLASCOTERONE","trade_name":"WINLEVI","family_id":"c7936e5861964962ac18","publication_number":"US8865690B2","cleaned_patent_number":"8865690","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-07-24","publication_date":"2014-10-21","legal_status":"Expired"} | US8865690B2 | 21 Oct, 2014 | Expired | 24 Jul, 2025 | |
| {"application_id":"55422","ingredient":"CLASCOTERONE","trade_name":"WINLEVI","family_id":"c7936e5861964962ac18","publication_number":"US8143240B2","cleaned_patent_number":"8143240","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-01-12","publication_date":"2012-03-27","legal_status":"Expired"} | US8143240B2 | 27 Mar, 2012 | Expired | 12 Jan, 2026 | |
| {"application_id":"55414","ingredient":"CLASCOTERONE","trade_name":"WINLEVI","family_id":"7514cb040926453e8de9","publication_number":"US9486458B2","cleaned_patent_number":"9486458","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-07-24","publication_date":"2016-11-08","legal_status":"Granted"} | US9486458B2 | 08 Nov, 2016 | Granted | 24 Jul, 2028 | |
| {"application_id":"123437","ingredient":"CLASCOTERONE","trade_name":"WINLEVI","family_id":"","publication_number":"US11938141B2","cleaned_patent_number":"11938141","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-07-24","publication_date":"2024-03-26","legal_status":"Granted"} | US11938141B2 Formulation | 26 Mar, 2024 | Granted | 24 Jul, 2028 | |
| {"application_id":"55415","ingredient":"CLASCOTERONE","trade_name":"WINLEVI","family_id":"7514cb040926453e8de9","publication_number":"US10159682B2","cleaned_patent_number":"10159682","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-14","publication_date":"2018-12-25","legal_status":"Granted"} | US10159682B2 | 25 Dec, 2018 | Granted | 14 Aug, 2028 | |
| {"application_id":"55348","ingredient":"CLASCOTERONE","trade_name":"WINLEVI","family_id":"7514cb040926453e8de9","publication_number":"US11207332B2","cleaned_patent_number":"11207332","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-11-20","publication_date":"2021-12-28","legal_status":"Granted"} | US11207332B2 Formulation | 28 Dec, 2021 | Granted | 20 Nov, 2028 | |
| {"application_id":"55413","ingredient":"CLASCOTERONE","trade_name":"WINLEVI","family_id":"7514cb040926453e8de9","publication_number":"US9433628B2","cleaned_patent_number":"9433628","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-28","publication_date":"2016-09-06","legal_status":"Granted"} | US9433628B2 Formulation | 06 Sep, 2016 | Granted | 28 Feb, 2029 | |
| {"application_id":"55412","ingredient":"CLASCOTERONE","trade_name":"WINLEVI","family_id":"7514cb040926453e8de9","publication_number":"US8785427B2","cleaned_patent_number":"8785427","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-25","publication_date":"2014-07-22","legal_status":"Granted"} | US8785427B2 Formulation | 22 Jul, 2014 | Granted | 25 Jul, 2030 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.