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Last Updated: August 2, 2021

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PICATO Drug Patent Profile


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Which patents cover Picato, and what generic alternatives are available?

Picato is a drug marketed by Leo Labs and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-five patent family members in twenty-one countries.

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ingenol mebutate profile page.

DrugPatentWatch® Generic Entry Outlook for Picato

Picato was eligible for patent challenges on January 23, 2016.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (ingenol mebutate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for PICATO
Drug Prices for PICATO

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Recent Clinical Trials for PICATO

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SponsorPhase
Instituto Nacional de Cancer, BrazilPhase 1/Phase 2
LEO PharmaEarly Phase 1
Center for Clinical Studies, TexasEarly Phase 1

See all PICATO clinical trials

Pharmacology for PICATO
Drug ClassCell Death Inducer
Physiological EffectIncreased Cellular Death
Paragraph IV (Patent) Challenges for PICATO
Tradename Dosage Ingredient NDA Submissiondate
PICATO GEL;TOPICAL ingenol mebutate 202833 2016-01-27

US Patents and Regulatory Information for PICATO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PICATO

Supplementary Protection Certificates for PICATO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1988877 PA2014030 Lithuania ⤷  Free Forever Trial PRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115
1988877 122014000075 Germany ⤷  Free Forever Trial PRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115
1988877 2014C/045 Belgium ⤷  Free Forever Trial PRODUCT NAME: MEBUTATE D'INGENOL OU L'UN DE SES DERIVES (SELS OU ESTER); AUTHORISATION NUMBER AND DATE: EU/1/12/796 20121119
1988877 C01988877/01 Switzerland ⤷  Free Forever Trial PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1015413 1390022-0 Sweden ⤷  Free Forever Trial PRODUCT NAME: INGENAN ELLER ETT DERIVAT (SALT ELLER ESTER) DAERAV; REG. NO/DATE: EU/1/12/796/001 20121115
1988877 C201430051 Spain ⤷  Free Forever Trial PRODUCT NAME: INGENOL MEBUTATO O UN DERIVADO ESTER DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/12/796; DATE OF AUTHORISATION: 20121115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/796; DATE OF FIRST AUTHORISATION IN EEA: 20121115
1015413 C300592 Netherlands ⤷  Free Forever Trial PRODUCT NAME: INGENAN OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796/001-002 20121115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Johnson and Johnson
Medtronic
McKinsey
Moodys

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