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Last Updated: July 2, 2022

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
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:GEL;TOPICALStrength0.015%
Approval Date:Jan 23, 2012TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Jul 6, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Dec 18, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Dec 18, 2026Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 202833

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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