Clobetasol Propionate Global Patent Coverage & Expiry Overview

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It is formulated by 31 pharmaceutical companies such as ACTAVIS MID ATLANTIC, PADAGIS US, TARO and others. It is marketed under 5 brand names, including CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE (EMOLLIENT), IMPOYZ and others. Available in 2 different strengths, such as 0.05%, 0.025%, and administered through 9 routes including SHAMPOO;TOPICAL, SPRAY;TOPICAL, LOTION;TOPICAL and others.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"43106","ingredient":"CLOBETASOL PROPIONATE","trade_name":"OLUX E","family_id":"4c18997e3c5142658a32","publication_number":"US8962000B2","cleaned_patent_number":"8962000","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-08-31","publication_date":"2015-02-24","legal_status":"Granted"} US8962000B2 Formulation 24 Feb, 2015 Granted 31 Aug, 2025
{"application_id":"43088","ingredient":"CLOBETASOL PROPIONATE","trade_name":"OLUX E","family_id":"4c18997e3c5142658a32","publication_number":"US8460641B2","cleaned_patent_number":"8460641","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-11-05","publication_date":"2013-06-11","legal_status":"Granted"} US8460641B2 Formulation 11 Jun, 2013 Granted 05 Nov, 2028
{"application_id":"54720","ingredient":"CLOBETASOL PROPIONATE","trade_name":"IMPOYZ","family_id":"14b6959345fc44e3b23e","publication_number":"US9956231B1","cleaned_patent_number":"9956231","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-31","publication_date":"2018-05-01","legal_status":"Granted"} US9956231B2 Formulation 01 May, 2018 Granted 31 Aug, 2030
{"application_id":"54722","ingredient":"CLOBETASOL PROPIONATE","trade_name":"IMPOYZ","family_id":"14b6959345fc44e3b23e","publication_number":"US10588914B2","cleaned_patent_number":"10588914","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-31","publication_date":"2020-03-17","legal_status":"Granted"} US10588914B2 Formulation 17 Mar, 2020 Granted 31 Aug, 2030
{"application_id":"54708","ingredient":"CLOBETASOL PROPIONATE","trade_name":"IMPOYZ","family_id":"14b6959345fc44e3b23e","publication_number":"US10064875B2","cleaned_patent_number":"10064875","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-31","publication_date":"2018-09-04","legal_status":"Granted"} US10064875B2 Formulation 04 Sep, 2018 Granted 31 Aug, 2030
{"application_id":"54729","ingredient":"CLOBETASOL PROPIONATE","trade_name":"IMPOYZ","family_id":"0be2fba8ffb448e3a67f","publication_number":"US9855334B2","cleaned_patent_number":"9855334","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-03-11","publication_date":"2018-01-02","legal_status":"Granted"} US9855334B2 Formulation 02 Jan, 2018 Granted 11 Mar, 2035
{"application_id":"122910","ingredient":"CLOBETASOL PROPIONATE","trade_name":"BYQLOVI","family_id":"","publication_number":"US10588913B2","cleaned_patent_number":"10588913","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-05-09","publication_date":"2020-03-17","legal_status":"Granted"} US10588913B2 Formulation 17 Mar, 2020 Granted 09 May, 2036
{"application_id":"122909","ingredient":"CLOBETASOL PROPIONATE","trade_name":"BYQLOVI","family_id":"","publication_number":"US11376262B2","cleaned_patent_number":"11376262","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-05-09","publication_date":"2022-07-05","legal_status":"Granted"} US11376262B2 Formulation 05 Jul, 2022 Granted 09 May, 2036

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

NCT ID Title Status Phase Conditions Start Date Completion Date

API Suppliers/Manufacturer (Branded/Generic companies)

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.