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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 ingenol mebutate freedom to operate?

Ingenol mebutate is the generic ingredient in one branded drug marketed by Leo Labs and is included in one NDA. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Summary for ingenol mebutate

International Patents:	53
US Patents:	16
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	22
Clinical Trials:	46
Patent Applications:	37
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ingenol mebutate
DailyMed Link:	ingenol mebutate at DailyMed

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

(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 (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)

PL008725

POL-103A

SCHEMBL2526605

UNII-7686S50JAH

VDJHFHXMUKFKET-WDUFCVPESA-N

ZINC100037855

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

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Non-Orange Book US Patents for ingenol mebutate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,603,822	Therapeutic compositions

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International Patents for ingenol mebutate

Country	Document Number	Estimated Expiration
Australia	736230
Eurasian Patent Organization	024152
Hungary	228862
South Korea	20140088617

Supplementary Protection Certificates for ingenol mebutate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014030	Lithuania		PRODUCT NAME: INGENOLI MEBUTATUM; REGISTRATION NO/DATE: EU/1/'12/796/001, 2012 11 15 EU/1/12/796/002 20121115
2014000075	Germany		PRODUCT NAME: INGENOLMEBUTAT ODER EIN DERIVAT (SALZ ODER ESTER) DAVON; REGISTRATION NO/DATE: EU/1/12/796 20121115
1988877/01	Switzerland		PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
5	Finland