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Last Updated: November 5, 2024

Details for New Drug Application (NDA): 209305


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

The generic ingredient in ESKATA is hydrogen peroxide. There are fifty-three drug master file entries for this compound. Additional details are available on the hydrogen peroxide profile page.
Summary for 209305
Tradename:ESKATA
Applicant:Aclaris
Ingredient:hydrogen peroxide
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209305
Generic Entry Date for 209305*:
Constraining patent/regulatory exclusivity:
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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;TOPICALStrength40%
Approval Date:Dec 14, 2017TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 21, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEBORRHEIC KERATOSES THAT ARE RAISED
Patent:⤷  Sign UpPatent Expiration:Apr 21, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Apr 21, 2035Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 209305

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aclaris ESKATA hydrogen peroxide SOLUTION;TOPICAL 209305-001 Dec 14, 2017 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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