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Last Updated: June 20, 2024

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.

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

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
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Therapeutic compositions
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Therapeutic compositions
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Therapeutic compositions
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Therapeutic compositions
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Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Therapeutic compositions
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Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Therapeutic compositions
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Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

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

Therapeutic compositions
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Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Therapeutic compositions
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Therapeutic compositions
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Therapeutic compositions
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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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 202833-001 Jan 23, 2012 ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 ⤷  Sign Up ⤷  Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for PICATO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
LEO Laboratories Ltd. Picato ingenol mebutate EMEA/H/C/002275
Picato is indicated for the cutaneous treatment of non‑hyperkeratotic, non‑hypertrophic actinic keratosis in adults.
Withdrawn no no no 2012-11-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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
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Brazil

Patent: 0619919
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Canada

Patent: 34073
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Cyprus

Patent: 15292
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Patent: 14030
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Denmark

Patent: 88877
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Eurasian Patent Organization

Patent: 8545
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Patent: 4152
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Patent: 0870063
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Patent: 1201452
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European Patent Office

Patent: 88877
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Patent: 99571
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Hungary

Patent: 20998
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Israel

Patent: 2221
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Japan

Patent: 84733
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Patent: 09826
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Patent: 09519314
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Patent: 13049715
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Mexico

Patent: 08007685
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New Zealand

Patent: 9197
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Norway

Patent: 4271
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Patent: 083150
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Poland

Patent: 88877
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Portugal

Patent: 88877
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Slovenia

Patent: 88877
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South Africa

Patent: 0805187
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South Korea

Patent: 1451993
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Patent: 1593579
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Patent: 080092373
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Patent: 140088617
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Spain

Patent: 61315
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United Kingdom

Patent: 25680
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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
Japan 5484733 ⤷  Sign Up
Canada 2301082 COMPOSES ANTICANCEREUX (ANTI-CANCER COMPOUNDS) ⤷  Sign Up
Japan 2013049715 THERAPEUTIC COMPOSITION ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PICATO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1015413 CA 2013 00024 Denmark ⤷  Sign Up
1015413 92185 Luxembourg ⤷  Sign Up PRODUCT NAME: INGENANE OU UN DERIVE(SEL OU ESTER)DE CELUI-CI
1988877 46/2014 Austria ⤷  Sign Up PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: EU/1/12/796/001 - 002 20121119
>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.