Details for New Drug Application (NDA): 202833

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NDA 202833 describes PICATO, which is a drug marketed by Leo Labs and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PICATO profile page.

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this compound. Additional details are available on the ingenol mebutate profile page.

Summary for 202833

Tradename:	PICATO
Applicant:	Leo Labs
Ingredient:	ingenol mebutate
Patents:	12

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TOPICAL			Strength	0.015%
Approval Date:	Jan 23, 2012	TE:		RLD:	Yes
Patent:	8,278,292	Patent Expiration:	Jul 6, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,372,827	Patent Expiration:	Dec 18, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,372,828	Patent Expiration:	Dec 18, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 202833

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	6,787,161	⤷ Subscribe
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012	6,432,452	⤷ Subscribe
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	6,844,013	⤷ Subscribe
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	7,410,656	⤷ Subscribe
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	6,432,452	⤷ Subscribe
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012	7,410,656	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.