EPIDUO FORTE Drug Patent Profile

Which patents cover Epiduo Forte, and what generic alternatives are available?

Epiduo Forte is a drug marketed by Galderma Labs and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-nine patent family members in twenty-two countries.

The generic ingredient in EPIDUO FORTE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this compound. Fourteen 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 Forte

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

Summary for EPIDUO FORTE

International Patents:	39
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	31
Patent Applications:	26
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EPIDUO FORTE
Drug Sales Revenues:	Drug sales revenues for EPIDUO FORTE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPIDUO FORTE
What excipients (inactive ingredients) are in EPIDUO FORTE?	EPIDUO FORTE excipients list
DailyMed Link:	EPIDUO FORTE at DailyMed

See drug prices for EPIDUO FORTE

See drug sales revenues for EPIDUO FORTE

Recent Clinical Trials for EPIDUO FORTE

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

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

See all EPIDUO FORTE clinical trials

Pharmacology for EPIDUO FORTE

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for EPIDUO FORTE

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 FORTE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPIDUO FORTE	Gel	adapalene; benzoyl peroxide	0.3%/2.5%	207917	1	2016-05-04

US Patents and Regulatory Information for EPIDUO FORTE

EPIDUO FORTE is protected by four US patents.

Patents protecting EPIDUO FORTE

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

Expired US Patents for EPIDUO FORTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015

International Patents for EPIDUO FORTE

When does loss-of-exclusivity occur for EPIDUO FORTE?

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 FORTE around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1107583
Australia	2002364437
Russian Federation	2008118056	ПРИМЕНЕНИЕ 6-[3-(1-АДАМАНТИЛ)-4-МЕТОКСИФЕНИЛ]-2-НАФТОЙНОЙ КИСЛОТЫ ДЛЯ ЛЕЧЕНИЯ ДЕРМАТОЛОГИЧЕСКИХ РАССТРОЙСТВ
Germany	60216634
Hungary	E025484
Spain	2319778

Supplementary Protection Certificates for EPIDUO FORTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
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	C01458369/01	Switzerland		PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369	380	Finland
1458369	SZ 31/2008	Austria		PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID