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Leo Labs Company Profile

LEO LABS has one approved drug.

There are thirteen US patents protecting LEO LABS drugs.

There are forty-eight patent family members on LEO LABS drugs in twenty-five countries and nineteen supplementary protection certificates in fifteen countries.

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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	9,861,603	Start Trial				Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No	9,820,959	Start Trial	Y			Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No	7,410,656	Start Trial				Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No	8,716,271	Start Trial				Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No	8,377,919	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012	6,432,452	Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	7,410,656	Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012	7,410,656	Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	6,432,452	Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	6,787,161	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Gel	0.05%	➤ Subscribe	2016-01-27

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Country	Patent Number	Estimated Expiration
Japan	2001515059	Start Trial
Eurasian Patent Organization	024152	Start Trial
Hungary	228862	Start Trial
Slovenia	1988877	Start Trial
Hungary	0004262	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1988877	46/2014	Austria	Start Trial	PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: EU/1/12/796/001 - 002 20121119
1988877	C 2014 032	Romania	Start Trial	PRODUCT NAME: INGENOL MEBUTAT; NATIONAL AUTHORISATION NUMBER: EU/1/12/796; DATE OF NATIONAL AUTHORISATION: 20121115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/796; DATE OF FIRST AUTHORISATION IN EEA: 20121115
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	2014C/045	Belgium	Start Trial	PRODUCT NAME: MEBUTATE D'INGENOL OU L'UN DE SES DERIVES (SELS OU ESTER); AUTHORISATION NUMBER AND DATE: EU/1/12/796 20121119
1015413	C01015413/01	Switzerland	Start Trial	PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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