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Ingenol mebutate - Generic Drug Details

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What are the generic drug sources for ingenol mebutate and what is the scope of patent protection?

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-four patent family members in twenty-five 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:	54
US Patents:	13
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	29
Clinical Trials:	49
Patent Applications:	1,501
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ingenol mebutate
What excipients (inactive ingredients) are in ingenol mebutate?	ingenol mebutate excipients list
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

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

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	202833-001	Jan 23, 2012		DISCN	Yes	No			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No

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

International Patents for ingenol mebutate

Country	Patent Number	Estimated Expiration
Spain	2461315
Eurasian Patent Organization	200870063
Cyprus	1115292

Supplementary Protection Certificates for ingenol mebutate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1988877	300682	Netherlands		PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
1015413	CA 2013 00024	Denmark
1015413	C300592	Netherlands		PRODUCT NAME: INGENAN OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796/001-002 20121115