Last Updated: June 17, 2026

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 202833

Generic Entry Date for 202833^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial Dosage: GEL;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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:	⤷ Start Trial	Patent Expiration:	Jul 6, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Dec 18, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	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	202833-001	Jan 23, 2012	⤷ Start Trial	⤷ Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012	⤷ Start Trial	⤷ Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	⤷ Start Trial	⤷ Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	⤷ Start Trial	⤷ Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012	⤷ Start Trial	⤷ Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	⤷ Start Trial	⤷ Start Trial
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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