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Generated: September 23, 2018

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PICATO Drug 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 sixteen patents protecting this drug and one Paragraph IV challenge.

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
Generic Entry Opportunity Date for PICATO
Generic Entry Date for PICATO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
GEL;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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
(1S,4S,5S,6R,9S,10R,12R,14R)-5,6-DIHYDROXY-7-(HYDROXYMETHYL)-3,11,11,14-TETRAMETHYL-15-OXOTETRACYCLO[7.5.1.0(1),?.0(1)?,(1)(2)]PENTADECA-2,7-DIEN-4-YL (2Z)-2-METHYLBUT-2-ENOATE
(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
CS-2971
D06HNG
D09393
D0E9KA
DB05013
Euphorbia factor An1
Euphorbia factor H1
GTPL7443
HSDB 8308
HY-B0719
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)
PL008725
POL-103A
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 202833-002 Jan 23, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 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 202833-002 Jan 23, 2012 ➤ Sign Up ➤ Sign Up
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014030 Lithuania ➤ Sign Up PRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115
00592 Netherlands ➤ Sign Up PRODUCT NAME: INGENAN OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796/001-002 20121115
2013 00024 Denmark ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Cantor Fitzgerald
Accenture
Covington
Julphar
Medtronic
Healthtrust
UBS
Harvard Business School

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