Ingenol Mebutate Global Patent Coverage & Expiry Overview

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It is formulated by 2 pharmaceutical companies such as LEO LABS, PADAGIS ISRAEL. It is marketed under 2 brand names, including PICATO, INGENOL MEBUTATE. Available in 2 different strengths, such as 0.015%, 0.05%, and administered through 1 route including GEL;TOPICAL.

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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":"4173","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"81d79f69b2654a248171","publication_number":"US9861603B2","cleaned_patent_number":"9861603","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-18","publication_date":"2018-01-09","legal_status":"Granted"} US9861603B2 09 Jan, 2018 Granted 18 Dec, 2026
{"application_id":"4159","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"81d79f69b2654a248171","publication_number":"US8372827B2","cleaned_patent_number":"8372827","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-18","publication_date":"2013-02-12","legal_status":"Granted"} US8372827B2 Formulation 12 Feb, 2013 Granted 18 Dec, 2026
{"application_id":"4170","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"81d79f69b2654a248171","publication_number":"US8372828B2","cleaned_patent_number":"8372828","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-18","publication_date":"2013-02-12","legal_status":"Granted"} US8372828B2 Formulation 12 Feb, 2013 Granted 18 Dec, 2026
{"application_id":"4176","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"81d79f69b2654a248171","publication_number":"US8377919B2","cleaned_patent_number":"8377919","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-18","publication_date":"2013-02-19","legal_status":"Granted"} US8377919B2 Formulation 19 Feb, 2013 Granted 18 Dec, 2026
{"application_id":"4175","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"81d79f69b2654a248171","publication_number":"US8536163B2","cleaned_patent_number":"8536163","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-18","publication_date":"2013-09-17","legal_status":"Granted"} US8536163B2 17 Sep, 2013 Granted 18 Dec, 2026
{"application_id":"4171","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"81d79f69b2654a248171","publication_number":"US8716271B2","cleaned_patent_number":"8716271","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-18","publication_date":"2014-05-06","legal_status":"Granted"} US8716271B2 06 May, 2014 Granted 18 Dec, 2026
{"application_id":"4161","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"81d79f69b2654a248171","publication_number":"US8735375B2","cleaned_patent_number":"8735375","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-18","publication_date":"2014-05-27","legal_status":"Granted"} US8735375B2 27 May, 2014 Granted 18 Dec, 2026
{"application_id":"4187","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"81d79f69b2654a248171","publication_number":"US9833428B2","cleaned_patent_number":"9833428","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-18","publication_date":"2017-12-05","legal_status":"Granted"} US9833428B2 Formulation 05 Dec, 2017 Granted 18 Dec, 2026
{"application_id":"4166","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"81d79f69b2654a248171","publication_number":"US9833429B2","cleaned_patent_number":"9833429","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-18","publication_date":"2017-12-05","legal_status":"Granted"} US9833429B2 Formulation 05 Dec, 2017 Granted 18 Dec, 2026
{"application_id":"4183","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"81d79f69b2654a248171","publication_number":"US9820959B2","cleaned_patent_number":"9820959","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-18","publication_date":"2017-11-21","legal_status":"Granted"} US9820959B2 Formulation 21 Nov, 2017 Granted 18 Dec, 2026
{"application_id":"4168","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"81d79f69b2654a248171","publication_number":"US8278292B2","cleaned_patent_number":"8278292","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-07-06","publication_date":"2012-10-02","legal_status":"Granted"} US8278292B2 Formulation 02 Oct, 2012 Granted 06 Jul, 2027
{"application_id":"59642","ingredient":"INGENOL MEBUTATE","trade_name":"PICATO","family_id":"eb42c29540da4414aef0","publication_number":"US9789078B2","cleaned_patent_number":"9789078","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-05-15","publication_date":"2017-10-17","legal_status":"Granted"} US9789078B2 17 Oct, 2017 Granted 15 May, 2033

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.

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