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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.

Summary for ingenol mebutate

International Patents:	52
US Patents:	13
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	24
Clinical Trials:	49
Patent Applications:	39
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ingenol mebutate
DailyMed Link:	ingenol mebutate at DailyMed

Recent Clinical Trials for ingenol mebutate

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

Sponsor	Phase
Instituto Nacional de Cancer, Brazil	Phase 1/Phase 2
Merete Haedersdal	Phase 1/Phase 2
University of California, San Francisco	Phase 1

See all ingenol mebutate clinical trials

Recent Litigation for ingenol mebutate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
LEO Pharma A/S v. Actavis Laboratories UT, Inc.	2018-03-14
LEO Pharma A/S v. Perrigo UK FINCO Limited Partnership	2018-03-14
LEO Pharma A/S v. Perrigo UK FINCO Limited Partnership	2016-06-10

See all ingenol mebutate litigation

Generic filers with tentative approvals for INGENOL MEBUTATE

Applicant	Application No.	Strength	Dosage Form
		0.05%	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 Class	Cell Death Inducer
Physiological Effect	Increased 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			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012	AB	RX	Yes	Yes
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012	AB	RX	Yes	Yes			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	AB	RX	Yes	Yes			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	AB	RX	Yes	Yes
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	AB	RX	Yes	Yes			Y

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
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012

International Patents for ingenol mebutate

Country	Patent Number	Estimated Expiration
South Korea	20140088617
Luxembourg	92185
Mexico	2008007685
European Patent Office	1015413
World Intellectual Property Organization (WIPO)	2013171258
Brazil	9811327

Supplementary Protection Certificates for ingenol mebutate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1988877	122014000075	Germany		PRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115
1988877	C20140025 00111	Estonia		PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
1988877	46/2014	Austria		PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: EU/1/12/796/001 - 002 20121119
1988877	C201430051	Spain		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		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