EPIDUO Drug Patent Profile

Which patents cover Epiduo, and when can generic versions of Epiduo launch?

Epiduo is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in two NDAs. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-four patent family members in twenty-six countries.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Epiduo

A generic version of EPIDUO was approved as adapalene; benzoyl peroxide by PADAGIS ISRAEL on January 23^rd, 2018.

Summary for EPIDUO

International Patents:	84
US Patents:	10
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	31
Patent Applications:	53
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EPIDUO
Drug Sales Revenues:	Drug sales revenues for EPIDUO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPIDUO
What excipients (inactive ingredients) are in EPIDUO?	EPIDUO excipients list
DailyMed Link:	EPIDUO at DailyMed

See drug prices for EPIDUO

See drug sales revenues for EPIDUO

Recent Clinical Trials for EPIDUO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bausch Health Americas, Inc.	Phase 2
Mahidol University	Phase 2
Beiersdorf	Phase 2

See all EPIDUO clinical trials

Pharmacology for EPIDUO

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for EPIDUO

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

D10AE	Peroxides
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for EPIDUO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPIDUO	Gel	adapalene; benzoyl peroxide	0.1%/2.5%	022320	1	2011-12-30

US Patents and Regulatory Information for EPIDUO

EPIDUO is protected by ten US patents.

Patents protecting EPIDUO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes			Y
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	AB	RX	Yes	Yes
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	AB	RX	Yes	Yes
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes			Y
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	AB	RX	Yes	Yes

Expired US Patents for EPIDUO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008

International Patents for EPIDUO

When does loss-of-exclusivity occur for EPIDUO?

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

Argentina

Australia

Brazil

Canada

China

Colombia

Cyprus

Denmark

European Patent Office

France

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Turkey

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 EPIDUO around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2046318
Luxembourg	85849
Norway	861413
Austria	347354
Japan	2016029094	座瘡病変の治療のためのアダパレンと過酸化ベンゾイルとの組合せ (COMBINATIONS OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS)
Denmark	162286
World Intellectual Property Organization (WIPO)	2008006888

Supplementary Protection Certificates for EPIDUO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	SPC/GB10/005	United Kingdom		PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369	122008000041	Germany		PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369	SZ 31/2008	Austria		PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
0199636	300209	Netherlands		300209, 20060411, EXPIRES: 20070702
1458369	380	Finland
1458369	132008901685368	Italy		PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618
1458369	08C0024	France		PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218