ESKATA Drug Patent Profile

Which patents cover Eskata, and what generic alternatives are available?

Eskata is a drug marketed by Aclaris and is included in one NDA. There are five patents protecting this drug.

This drug has eighteen patent family members in sixteen countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Eskata

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 21, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ESKATA

International Patents:	18
US Patents:	5
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	155
Patent Applications:	2,190
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in ESKATA?	ESKATA excipients list
DailyMed Link:	ESKATA at DailyMed

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

NDA:

209305

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.

US Patents and Regulatory Information for ESKATA

ESKATA is protected by five US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ESKATA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No			Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No			Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No			Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No			Y

Expired US Patents for ESKATA

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

International Patents for ESKATA

When does loss-of-exclusivity occur for ESKATA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Israel

Japan

Mexico

Poland

Portugal

Russian Federation

Singapore

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ESKATA around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2016013826	FORMULACIONES DE PEROXIDO Y METODOS Y APLICACIONES PARA UTILIZARLAS. (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME.)
Israel	157321
China	106659643	过氧化物制剂及使用过氧化物制剂的方法和施加器 (Peroxide formulations and methods and applicators for using the same)
Mexico	PA03007151	CURACION DE ACROCORDONES. (ACROCHORDON ALLEVIATION.)
Canada	2946568	FORMULES DE PEROXYDE ET PROCEDES ET APPLICATEURS POUR LEUR UTILISATION (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME)
Australia	2007203283

Supplementary Protection Certificates for ESKATA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0281459	98C0036	France		PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001
2523731	CR 2020 00025	Denmark		PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
1968948	CR 2021 00044	Denmark		PRODUCT NAME: SELUMETINIB HYDROGENSULFAT OG SOLVATER OG ANHYDRID FORMER DERAF; REG. NO/DATE: EU/1/21/1552 20210619
3106463	LUC00150	Luxembourg		PRODUCT NAME: LAROTRECTINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE SULFATE DE LAROTRECTINIB, Y COMPRIS L'HYDROGENOSULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923
3106463	2020/009	Ireland		PRODUCT NAME: LAROTRECTINIB AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REGISTRATION NO/DATE: EU/1/19/1385 20190923
2787345	CA 2016 00055	Denmark		PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531