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 six patents protecting this drug.

This drug has thirty-one patent family members in eighteen 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 June 8, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ESKATA

International Patents:	31
US Patents:	6
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	145
Patent Applications:	4,138
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in ESKATA?	ESKATA excipients list
DailyMed Link:	ESKATA at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity 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.

Anatomical Therapeutic Chemical (ATC) Classes for ESKATA

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D08AX	Other antiseptics and disinfectants
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ESKATA

ESKATA is protected by six 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

International Patents for ESKATA

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

Country	Patent Number	Title	Estimated Expiration
China	100508990
Japan	6622217
World Intellectual Property Organization (WIPO)	02064151

Supplementary Protection Certificates for ESKATA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2523731	CA 2020 00025	Denmark		PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
2523731	2020012	Norway		PRODUCT NAME: OSILODROSTAT ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV, INKLUDERT OSILODROSTAT DIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200203