Last Updated: November 8, 2026

Details for New Drug Application (NDA): 209305

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 is one drug master file entry 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^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial 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

Anti-Infective Agents, Local
Oxidants

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	40%
Approval Date:	Dec 14, 2017	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Apr 21, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF SEBORRHEIC KERATOSES THAT ARE RAISED
Patent:	⤷ Start Trial	Patent Expiration:	Apr 21, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Apr 21, 2035	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 209305

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

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Summary for 209305

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209305

Medical Subject Heading (MeSH) Categories for 209305

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209305