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ESKATA Drug Profile

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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 twenty-eight patent family members in fifteen 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.

US ANDA Litigation and Generic Entry Outlook for Eskata

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 14, 2020. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ESKATA

International Patents:	28
US Patents:	5
Applicants:	1
NDAs:	1
Bulk Api Vendors:	130
Patent Applications:	5,031
Formulation / Manufacturing:	see details
DailyMed Link:	ESKATA at DailyMed

Generic Entry Opportunity Date for ESKATA

Constraining patent/regulatory exclusivity:

NEW PRODUCT

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

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
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

International Patents for ESKATA

Country	Patent Number	Estimated Expiration
Brazil	112016024630
Brazil	0207163
Israel	157321
European Patent Office	3134061
Germany	60226953
Canada	2437823

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
0605697	SPC/GB01/008	United Kingdom		PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026
1419152	CR 2012 00019	Denmark		PRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
3106463	2020C/507	Belgium		PRODUCT NAME: VITRAKVI - LAROTRECTINIB ET/OU SES SELS ACCEPTABLES EN PHARMACIE, EN PARTICULIER L'HYDROGENO SULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923
3106463	122020000012	Germany		PRODUCT NAME: LAROTRECTINIB UND/ODER ANDERE PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFATE UMFASSEND LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190919
0302769	98C0036	Belgium		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