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Last Updated: May 26, 2022

PICATO Drug Patent Profile


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Which patents cover Picato, and when can generic versions of Picato launch?

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. 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.

Indicators of Generic Entry

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Drug patent expirations by year for PICATO
Drug Prices for PICATO

See drug prices for PICATO

Recent Clinical Trials for PICATO

Identify potential brand extensions & 505(b)(2) entrants

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

See all PICATO clinical trials

Paragraph IV (Patent) Challenges for PICATO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PICATO Gel ingenol mebutate 0.015% 202833 2 2016-01-27

US Patents and Regulatory Information for PICATO

PICATO is protected by twelve US patents.

Patents protecting PICATO

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Method of topically treating actinic keratosis with ingenol mebutate cycle therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP USING MORE THAN ONE TREATMENT COURSE OF INGENOL MEBUTATE

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PICATO

When does loss-of-exclusivity occur for PICATO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06325244
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0619919
Estimated Expiration: See Plans and Pricing

Canada

Patent: 34073
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15292
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 88877
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8545
Estimated Expiration: See Plans and Pricing

Patent: 4152
Estimated Expiration: See Plans and Pricing

Patent: 0870063
Estimated Expiration: See Plans and Pricing

Patent: 1201452
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 88877
Estimated Expiration: See Plans and Pricing

Patent: 99571
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 20998
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2221
Estimated Expiration: See Plans and Pricing

Patent: 5513
Estimated Expiration: See Plans and Pricing

Japan

Patent: 84733
Estimated Expiration: See Plans and Pricing

Patent: 09826
Estimated Expiration: See Plans and Pricing

Patent: 09519314
Estimated Expiration: See Plans and Pricing

Patent: 13049715
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 08007685
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9197
Estimated Expiration: See Plans and Pricing

Norway

Patent: 4271
Estimated Expiration: See Plans and Pricing

Patent: 083150
Estimated Expiration: See Plans and Pricing

Poland

Patent: 88877
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 88877
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 88877
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0805187
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1451993
Estimated Expiration: See Plans and Pricing

Patent: 1593579
Estimated Expiration: See Plans and Pricing

Patent: 080092373
Estimated Expiration: See Plans and Pricing

Patent: 140088617
Estimated Expiration: See Plans and Pricing

Spain

Patent: 61315
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 25680
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PICATO around the world.

Country Patent Number Title Estimated Expiration
Hungary 228862 THE USE OF AN INGENANE COMPOUND FOR PRODUCTION MEDICAMENT USEFUL FOR TREATMENT CANCER See Plans and Pricing
Australia PO864097 See Plans and Pricing
Japan 2015007130 抗癌化合物 (ANTI-CANCER COMPOUND) See Plans and Pricing
Australia 2006325244 Therapeutic compositions comprising ingenol-3-angelate See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PICATO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1988877 46/2014 Austria See Plans and Pricing PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: EU/1/12/796/001 - 002 20121119
1988877 C20140025 00111 Estonia See Plans and Pricing PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
1988877 C 2014 032 Romania See Plans and Pricing PRODUCT NAME: INGENOL MEBUTAT; NATIONAL AUTHORISATION NUMBER: EU/1/12/796; DATE OF NATIONAL AUTHORISATION: 20121115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/796; DATE OF FIRST AUTHORISATION IN EEA: 20121115
1988877 C201430051 Spain See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.