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Serving leading biopharmaceutical companies globally:

Queensland Health
Medtronic
Julphar
McKesson
Cipla
US Department of Justice
Fish and Richardson
Boehringer Ingelheim
Dow
Merck

Generated: January 24, 2018

DrugPatentWatch Database Preview

PICATO Drug 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 fifty-three patent family members in twenty-four 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.
Summary for PICATO
Drug patent expirations by year for PICATO
Pharmacology for PICATO
Drug ClassCell Death Inducer
Physiological EffectIncreased Cellular Death

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

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Paragraph IV (Patent) Challenges for PICATO
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Gel 0.05% ➤ Subscribe 1/27/2016

Non-Orange Book US Patents for PICATO

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,603,822 Therapeutic compositions ➤ Subscribe
9,833,429 Therapeutic compositions ➤ Subscribe
9,820,959 Therapeutic compositions ➤ Subscribe
9,833,428 Therapeutic compositions ➤ Subscribe
9,861,603 Therapeutic compositions ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for PICATO

Supplementary Protection Certificates for PICATO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0682 Netherlands ➤ Subscribe PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
2014 00042 Denmark ➤ Subscribe PRODUCT NAME: INGENOLMEBUTAT ELLER ET DERIVAT (SALT ELLER ESTER) DERAF); REG. NO/DATE: EU/1/12/796/001-002 20121115
C0058 France ➤ Subscribe PRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119
90022-0 Sweden ➤ Subscribe PRODUCT NAME: INGENAN ELLER ETT DERIVAT (SALT ELLER ESTER) DAERAV; REG. NO/DATE: EU/1/12/796/001 20121115
2014030 Lithuania ➤ Subscribe PRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115
2013 00024 Denmark ➤ Subscribe
1988877/01 Switzerland ➤ Subscribe PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
185 Luxembourg ➤ Subscribe PRODUCT NAME: INGENANE OU UN DERIVE(SEL OU ESTER)DE CELUI-CI
2014000075 Germany ➤ Subscribe PRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115
5 Finland ➤ Subscribe
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Federal Trade Commission
Deloitte
Fish and Richardson
Colorcon
Merck
AstraZeneca
Accenture
Argus Health

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 verifification 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.

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