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Leo Labs Company Profile

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What is the competitive landscape for LEO LABS, and what generic alternatives to LEO LABS drugs are available?

LEO LABS has one approved drug.

There are sixteen US patents protecting LEO LABS drugs.

There are forty-eight patent family members on LEO LABS drugs in twenty-four countries and fourteen supplementary protection certificates in ten countries.

Summary for Leo Labs

International Patents:	48
US Patents:	16
Tradenames:	1
Ingredients:	1
NDAs:	1

Drugs and US Patents for Leo Labs

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		RX	Yes	Yes	8,735,375
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		RX	Yes	Yes	8,372,828		Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		RX	Yes	Yes	8,716,271
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		RX	Yes	Yes	9,833,429		Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		RX	Yes	Yes	6,432,452
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		RX	Yes	Yes	8,278,292		Y

Expired US Patents for Leo Labs

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
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	6,787,161
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	6,432,452
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012	6,787,161
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	6,844,013
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012	6,844,013

Paragraph IV (Patent) Challenges for LEO LABS drugs

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

International Patents for Leo Labs Drugs

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	201201452
South Korea	101451993
Japan	5484733
Japan	2012031212
Japan	2015007130
Denmark	1015413

Supplementary Protection Certificates for Leo Labs Drugs

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	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	300682	Netherlands		PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
1015413	C300592	Netherlands		PRODUCT NAME: INGENAN OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796/001-002 20121115
1988877	C20140025 00111	Estonia		PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Leo Labs
• Leo Pharm
• Leo Pharma As