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Serving leading biopharmaceutical companies globally:

Harvard Business School
Covington
Teva
Chubb
McKinsey
Farmers Insurance
Johnson and Johnson
US Army
Daiichi Sankyo
McKesson

Generated: October 23, 2017

DrugPatentWatch Database Preview

PICATO Drug Profile

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

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

This drug has fifty-one patent family members in twenty-four countries and fourteen supplementary protection certificates in ten 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 Tradename: PICATO

US Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list15
Clinical Trials: see list15
Patent Applications: see list25
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:PICATO at DailyMed

Pharmacology for Tradename: PICATO

Drug ClassCell Death Inducer
Physiological EffectIncreased Cellular Death
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;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-002Jan 23, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-002Jan 23, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-002Jan 23, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-001Jan 23, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-002Jan 23, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Leo Labs
PICATO
ingenol mebutate
GEL;TOPICAL202833-002Jan 23, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
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Paragraph IV (Patent) Challenges for PICATO

Drugname Dosage Strength RLD Submissiondate
ingenol mebutateGel0.05%Picato1/27/2016

Non-Orange Book Patents for Tradename: 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
9,603,822Therapeutic compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: PICATO

Country Document Number Estimated Expiration
Luxembourg92185► Subscribe
Japan2009519314► Subscribe
Australia8721798► Subscribe
Japan5484733► Subscribe
Japan2015007130► Subscribe
Germany69839586► Subscribe
Slovenia1988877► Subscribe
China1266421► Subscribe
Denmark1988877► Subscribe
Portugal1988877► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PICATO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
185Luxembourg► SubscribePRODUCT NAME: INGENANE OU UN DERIVE(SEL OU ESTER)DE CELUI-CI
2014 00042Denmark► SubscribePRODUCT NAME: INGENOLMEBUTAT ELLER ET DERIVAT (SALT ELLER ESTER) DERAF); REG. NO/DATE: EU/1/12/796/001-002 20121115
0682Netherlands► SubscribePRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
1988877/01Switzerland► SubscribePRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
00592Netherlands► SubscribePRODUCT NAME: INGENAN OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796/001-002 20121115
5Finland► Subscribe
0140025 00111Estonia► SubscribePRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
90022-0Sweden► SubscribePRODUCT NAME: INGENAN ELLER ETT DERIVAT (SALT ELLER ESTER) DAERAV; REG. NO/DATE: EU/1/12/796/001 20121115
2014030Lithuania► SubscribePRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115
2014000075Germany► SubscribePRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Chinese Patent Office
Fish and Richardson
Daiichi Sankyo
Colorcon
Medtronic
Citi
Baxter
Federal Trade Commission
US Army

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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