INGENOL MEBUTATE - Generic Drug Details

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

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

Ingenol mebutate has thirty-five patent family members in twenty-one countries.

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

Summary for INGENOL MEBUTATE

International Patents:	35
US Patents:	12
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	50
Patent Applications:	978
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
Nova Scotia Health Authority	Phase 4
Instituto Nacional de Cancer, Brazil	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.

Anatomical Therapeutic Chemical (ATC) Classes for INGENOL MEBUTATE

D06BX	Other chemotherapeutics
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for INGENOL MEBUTATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PICATO	Gel	ingenol mebutate	0.015%	202833	2	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		DISCN	Yes	No			Y
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			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No			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	202833-002	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
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012

EU/EMA Drug Approvals for INGENOL MEBUTATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
LEO Laboratories Ltd.	Picato	ingenol mebutate	EMEA/H/C/002275 Picato is indicated for the cutaneous treatment of non‑hyperkeratotic, non‑hypertrophic actinic keratosis in adults.	Withdrawn	no	no	no	2012-11-15

International Patents for INGENOL MEBUTATE

Country	Patent Number	Title	Estimated Expiration
South Africa	200805187	Therapeutic compositions
European Patent Office	2849742	PROCÉDÉ DE TRAITEMENT TOPIQUE DE LA KÉRATOSE ACTINIQUE AVEC UN TRAITEMENT CYCLIQUE AU MÉBUTATE D'INGÉNOL (METHOD OF TOPICALLY TREATING ACTINIC KERATOSIS WITH INGENOL MEBUTATE CYCLE THERAPY)
South Korea	101451993
European Patent Office	1988877	COMPOSITIONS THERAPEUTIQUES COMPRENANT DE L'INGÉNOL-3-ANGELATE (THERAPEUTIC COMPOSITIONS COMPRISING INGENOL-3-ANGELATE)
Cyprus	2014030

Supplementary Protection Certificates for INGENOL MEBUTATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1988877	46/2014	Austria		PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: EU/1/12/796/001 - 002 20121119
1988877	132014902287215	Italy		PRODUCT NAME: INGENOLO MEBUTATO O UN SUO DERIVATO (SALE O ESTERE)(PICATO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/796/001-002, 20121119
1988877	14C0058	France		PRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119
1988877	C300682	Netherlands		PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 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