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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

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. It is available from one supplier. There are thirteen 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. One supplier is listed 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:13
Formulation / Manufacturing:see details
Pharmacology for NDA: 202833
Physiological EffectIncreased Cellular Death
Suppliers and Packaging for NDA: 202833
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PICATO ingenol mebutate GEL;TOPICAL 202833 NDA LEO Pharma Inc. 50222-502 50222-502-47 3 TUBE in 1 CARTON (50222-502-47) > .47 g in 1 TUBE
PICATO ingenol mebutate GEL;TOPICAL 202833 NDA LEO Pharma Inc. 50222-502 50222-502-91 3 TUBE in 1 CARTON (50222-502-91) > .47 g in 1 TUBE
Paragraph IV (Patent) Challenges for 202833
Tradename Dosage Ingredient NDA Submissiondate
PICATO GEL;TOPICAL ingenol mebutate 202833 2016-01-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.015%
Approval Date:Jan 23, 2012TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Oct 10, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TO INHIBIT THE PROLIFERATIVE ACTIVITY OF NEOPLASTIC CELLS
Patent:  Start TrialPatent Expiration:Jul 6, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent 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   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 202833-002 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 202833-001 Jan 23, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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