Aclaris Company Profile

What is the competitive landscape for ACLARIS, and when can generic versions of ACLARIS drugs launch?

ACLARIS has one approved drug.

There are five US patents protecting ACLARIS drugs.

There are fifteen patent family members on ACLARIS drugs in sixteen countries and thirty-six supplementary protection certificates in ten countries.

Summary for Aclaris

International Patents:	15
US Patents:	5
Tradenames:	1
Ingredients:	1
NDAs:	1

Drugs and US Patents for Aclaris

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	10,493,103		Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	9,980,983
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	9,675,639		Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	10,098,910		Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	10,729,720		Y

Expired US Patents for Aclaris

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017	7,381,427

International Patents for Aclaris Drugs

Country	Patent Number	Estimated Expiration
South Korea	20170029413
Mexico	2016013826
Japan	6622217
Spain	2828711
Denmark	3134061
Russian Federation	2711662
Japan	2017513907

Supplementary Protection Certificates for Aclaris Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1968948	122021000074	Germany		PRODUCT NAME: SELUMETINIB (EINSCHLIESSLICH PHARMAZEUTISCH AKZEPTABLER SALZE (INSBESONDERE HYDROGENSULFAT), ESTER, SOLVATE ODER ENANTIOMERE DAVON); REGISTRATION NO/DATE: EU/1/21/1552 20210617
1968948	2021C/549	Belgium		PRODUCT NAME: SELUMETINIB (Y COMPRIS TOUS SELS PHARMACEUTIQUEMENT ACCEPTABLES (EN PARTICULIER HYDROGENOSULFATE), ESTERS, SOLVATES OU ENANTIOMERES DE CEUX-CI); AUTHORISATION NUMBER AND DATE: EU/1/21/1552 20210619
1968948	CA 2021 00044	Denmark		PRODUCT NAME: SELUMETINIB, INKLUSIV FARMACEUTISK ACCEPTABLE SALTE (ISAER HYDROGENSULFAT), ESTRE, SOLVATER OG ENANTIOMERE DERAF; REG. NO/DATE: EU/1/21/1552 20210619
2523731	LUC00159	Luxembourg		PRODUCT NAME: OSILODROSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE DIHYDROGENOPHOSPHATE D'OSILODROSTAT; AUTHORISATION NUMBER AND DATE: EU/1/19/1407 20200113
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
0281459	35/1998	Austria		PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Aclaris