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Last Updated: November 13, 2019

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 thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-two 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.

Drug patent expirations by year for PICATO
Drug Prices for PICATO

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Recent Clinical Trials for PICATO

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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

Recent Litigation for PICATO

Identify potential future generic entrants

District Court Litigation
Case NameDate
LEO Pharma A/S v. Actavis Laboratories UT, Inc.2018-03-14
LEO Pharma A/S v. Perrigo UK FINCO Limited Partnership2018-03-14
LEO Pharma A/S v. Perrigo UK FINCO Limited Partnership2016-06-10

See all PICATO litigation

Pharmacology for PICATO
Drug ClassCell Death Inducer
Physiological EffectIncreased Cellular Death
Synonyms for PICATO
(1aR,2S,5R,5aS,6S,8aS,9R,10aR)-5,5a-Dihydroxy-4-(hydroxymethyl)-1,1,7,9-tetramethyl-11-oxo-1a,2,5,5a,6,9,10,10a-octahydro-1H-2,8a- methanocyclopenta(a)cyclopropa(e)cyclodecen-6-yl (2Z)-2-methylbut-2-enoate
(1aR,2S,5R,5aS,6S,8aS,9R,10aR)-5,5a-dihydroxy-4-(hydroxymethyl)-1,1,7,9-tetramethyl-11-oxo-1a,2,5,5a,6,9,10,10a-octahydro-1H-2,8a-methanocyclopenta[a]cyclopropa[e][10]annulen-6-yl
(2Z)-2-Methyl-2-butenoic acid (1aR,2S,5R,5aS,6S,8aS,9R,10aR)-1a,2,5,5a,6,9,10,10a-octahydro-5,5a-dihydroxy-4-(hydroxymethyl)-1,1,7,9-tetramethyl-11-oxo-1H-2,8a-methanocyclopenta[a]cyclopropa[e]cyclodecen-6-yl ester
(Z)-2-methylbut-2-enoate
[dihydroxy-(hydroxymethyl)-tetramethyl-oxo-[?]yl] (Z)-2-methylbut-2-enoate
2-Butenoic acid, 2-methyl-, (1aR,2S,5R,5aS,6S,8aS,9R,10aR)-1a,2,5,5a,6,9,10,10a-octahydro-5,5a-dihydroxy-4-(hydroxymethyl)-1,1,7,9-tetramethyl-11-oxo-1H-2,8a-methanocyclopenta[a]cyclopropa[e]cyclodecen-6-yl ester, (2Z)-
3-Angeloylingenol
3-Ingenyl angelate
75567-37-2
7686S50JAH
849146-39-0
ACN-035815
AKOS024457952
AN-262
CHEMBL1863513
D09393
DB05013
Euphorbia factor An1
Euphorbia factor H1
GTPL7443
HSDB 8308
I3A
Ingenol 3-angelate
Ingenol mebutate
Ingenol mebutate (USAN)
Ingenol mebutate [USAN:INN]
Ingenol-3- angelate
Ingenol-3-angelate
Ingenol-3-angelate, >=95% (HPLC)
Ingenol-3-angelate;
MolPort-003-941-761
PEP 005
PEP-005
PEP005
Picato (TN)
SCHEMBL2526605
UNII-7686S50JAH
VDJHFHXMUKFKET-WDUFCVPESA-N
ZINC100037855
Paragraph IV (Patent) Challenges for PICATO
Tradename Dosage Ingredient NDA Submissiondate
PICATO GEL;TOPICAL ingenol mebutate 202833 2016-01-27

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 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start 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   Start Trial   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012   Start Trial   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012   Start Trial   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012   Start Trial   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012   Start Trial   Start Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PICATO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1988877 300682 Netherlands   Start Trial PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
1988877 122014000075 Germany   Start Trial PRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115
1988877 14C0058 France   Start Trial PRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119
1015413 C01015413/01 Switzerland   Start Trial PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1988877 C300682 Netherlands   Start Trial PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
1988877 C 2014 032 Romania   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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