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Generated: April 24, 2019

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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
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

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 AB RX Yes Yes ➤ 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

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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
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 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

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Paragraph IV (Patent) Challenges for PICATO
Drugname Dosage Strength RLD Date
➤ Subscribe Gel 0.05% ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for PICATO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1988877 14C0058 France ➤ Sign Up PRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119
1015413 1390022-0 Sweden ➤ Sign Up PRODUCT NAME: INGENAN ELLER ETT DERIVAT (SALT ELLER ESTER) DAERAV; REG. NO/DATE: EU/1/12/796/001 20121115
1988877 C01988877/01 Switzerland ➤ Sign Up PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1015413 505 Finland ➤ Sign Up
1015413 C01015413/01 Switzerland ➤ Sign Up PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1988877 300682 Netherlands ➤ Sign Up PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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