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Last Updated: November 19, 2019

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Ingenol mebutate - Generic Drug Details

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What are the generic sources for ingenol mebutate and what is the scope of freedom to operate?

Ingenol mebutate is the generic ingredient in two branded drugs marketed by Perrigo Uk Finco and Leo Labs, and is included in three NDAs. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ingenol mebutate has fifty-two patent family members in twenty-four countries.

There are three drug master file entries for ingenol mebutate. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for ingenol mebutate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Instituto Nacional de Cancer, BrazilPhase 1/Phase 2
Merete HaedersdalPhase 1/Phase 2
University of California, San FranciscoPhase 1

See all ingenol mebutate clinical trials

Recent Litigation for ingenol mebutate

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 ingenol mebutate litigation

Generic filers with tentative approvals for INGENOL MEBUTATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.05%GEL; TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ingenol mebutate
Drug ClassCell Death Inducer
Physiological EffectIncreased Cellular Death
Synonyms for ingenol mebutate
(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 (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
Picato (TN)
SCHEMBL2526605
UNII-7686S50JAH
VDJHFHXMUKFKET-WDUFCVPESA-N
ZINC100037855
Paragraph IV (Patent) Challenges for INGENOL MEBUTATE
Tradename Dosage Ingredient NDA Submissiondate
PICATO GEL;TOPICAL ingenol mebutate 202833 2016-01-27

US Patents and Regulatory Information for ingenol mebutate

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 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 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 202833-002 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
>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 ingenol mebutate

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 ingenol mebutate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1988877 122014000075 Germany   Start Trial PRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115
1988877 C20140025 00111 Estonia   Start Trial PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
1988877 46/2014 Austria   Start Trial PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: EU/1/12/796/001 - 002 20121119
1988877 C201430051 Spain   Start Trial PRODUCT NAME: INGENOL MEBUTATO O UN DERIVADO ESTER DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/12/796; DATE OF AUTHORISATION: 20121115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/796; DATE OF FIRST AUTHORISATION IN EEA: 20121115
1988877 PA2014030 Lithuania   Start Trial PRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115
1015413 CA 2013 00024 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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