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Generated: November 13, 2018

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 sixteen 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:16
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 202833
Generic Entry Date for 202833*:
Constraining patent/regulatory exclusivity:
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.

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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.015%
Approval Date:Jan 23, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 19, 2018
Regulatory Exclusivity Use:UPDATES TO LABELING DESCRIBING RESPONSE TO A REPEAT COURSE OF PICATO GEL 0.015% ON THE FACE OR SCALP IF AN INCOMPLETE RESPONSE IS OBSERVED AT A FOLLOW-UP EXAMINATION.
Patent:➤ Try a Free TrialPatent Expiration:Aug 19, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACTINIC KERATOSIS
Patent:➤ Try a Free TrialPatent Expiration:Aug 19, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACTINIC KERATOSIS

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 ➤ Try a Free Trial ➤ Try a Free Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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