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Last Updated: March 19, 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-four 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

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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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Therapeutic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Therapeutic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Therapeutic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Therapeutic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Therapeutic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Therapeutic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Method of topically treating actinic keratosis with ingenol mebutate cycle therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS

Therapeutic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Therapeutic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Therapeutic compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 ⤷  Try a Trial ⤷  Try a Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 ⤷  Try a Trial ⤷  Try a Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0619919
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 34073
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 15292
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 88877
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 8545
Estimated Expiration: ⤷  Try a Trial

Patent: 4152
Estimated Expiration: ⤷  Try a Trial

Patent: 0870063
Estimated Expiration: ⤷  Try a Trial

Patent: 1201452
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 88877
Estimated Expiration: ⤷  Try a Trial

Patent: 99571
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 20998
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2221
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 84733
Estimated Expiration: ⤷  Try a Trial

Patent: 09826
Estimated Expiration: ⤷  Try a Trial

Patent: 09519314
Estimated Expiration: ⤷  Try a Trial

Patent: 13049715
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 08007685
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9197
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 4271
Estimated Expiration: ⤷  Try a Trial

Patent: 083150
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 88877
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 88877
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 88877
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0805187
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1451993
Estimated Expiration: ⤷  Try a Trial

Patent: 1593579
Estimated Expiration: ⤷  Try a Trial

Patent: 080092373
Estimated Expiration: ⤷  Try a Trial

Patent: 140088617
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 61315
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 25680
Estimated Expiration: ⤷  Try a Trial

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
Australia 2006325244 Therapeutic compositions comprising ingenol-3-angelate ⤷  Try a Trial
Japan 5484733 ⤷  Try a Trial
New Zealand 569197 Therapeutic compositions comprising ingenol angelate ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PICATO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1988877 14C0058 France ⤷  Try a Trial PRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119
1015413 C01015413/01 Switzerland ⤷  Try a Trial PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1988877 C01988877/01 Switzerland ⤷  Try a Trial PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
>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.