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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209305

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NDA 209305 describes ESKATA, which is a drug marketed by Aclaris Theraps Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ESKATA profile page.

The generic ingredient in ESKATA is hydrogen peroxide. There are fifty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the hydrogen peroxide profile page.
Summary for 209305
Tradename:ESKATA
Applicant:Aclaris Theraps Inc
Ingredient:hydrogen peroxide
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 209305
Generic Entry Date for 209305*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
Dosage:
SOLUTION;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.

Medical Subject Heading (MeSH) Categories for 209305
Suppliers and Packaging for NDA: 209305
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESKATA hydrogen peroxide SOLUTION;TOPICAL 209305 NDA Aclaris Therapeutics, Inc. 71180-001 71180-001-01 1 APPLICATOR in 1 CARTON (71180-001-01) > 280 mg in 1 APPLICATOR
ESKATA hydrogen peroxide SOLUTION;TOPICAL 209305 NDA Aclaris Therapeutics, Inc. 71180-001 71180-001-03 3 APPLICATOR in 1 CARTON (71180-001-03) > 280 mg in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength40%
Approval Date:Dec 14, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 14, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Jun 8, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SEBORRHEIC KERATOSES THAT ARE RAISED
Patent:➤ Sign UpPatent Expiration:Jul 4, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEBORRHEIC KERATOSES THAT ARE RAISED

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