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EPIDUO FORTE Drug Patent Profile

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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.

The generic ingredient in EPIDUO FORTE 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 Forte

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

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Summary for EPIDUO FORTE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	31
Patent Applications:	22
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

Drug patent expirations by year 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
Mahidol University	Phase 2
Beiersdorf	Phase 2

See all EPIDUO FORTE clinical trials

Pharmacology for EPIDUO FORTE

Drug Class	Retinoid

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for EPIDUO FORTE

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

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

Patent: 1989
Patent: COMBINACION DE PEROXIDO DE ADAPALENO Y BENZOILO PARA EL TRATAMIENTO DE LESIONES DE ACNE
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 07274288
Patent: Combination of adapalene and benzoyl peroxide for treating acne lesions
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 0713182
Patent: usos de adapaleno de um de seus sais farmaceuticamente aceitáveis, kit e produto
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Canada

Patent: 56456
Patent: ADAPALENE ET PEROXYDE DE BENZOYLE COMBINES UTILISES DANS LE TRAITEMENT DE LESIONS DUES A L'ACNE (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS)
Estimated Expiration: ⤷ Sign Up

China

Patent: 1541320
Patent: Combination of adapalene and benzoyl peroxide for treating acne lesions
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 50136
Patent: COMBINACION DE ADAPALENO Y PEROXIDO DE BENZOILO PARA TRATAR LESIONES DE ACNE
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 14473
Estimated Expiration: ⤷ Sign Up

Patent: 21398
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 46318
Estimated Expiration: ⤷ Sign Up

Patent: 50035
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 46318
Patent: Combinaison d'adapalène et de peroxyde de benzoyle pour le traitement de lésions inflammatoires de l'acné (Combination of adapalene and benzoyl peroxide for treating inflammatory acne lesions)
Estimated Expiration: ⤷ Sign Up

Patent: 50035
Patent: Combinaison d'adapalène et de péroxyde de benzoyle dans le traitement des lésions acnéiques (Combination of adapalene and benzoyl peroxide for treating acne lesions)
Estimated Expiration: ⤷ Sign Up

France

Patent: 03603
Patent: COMBINAISON D'ADAPALENE ET DE PEROXYDE DE BENZOLE DANS LE TRAITEMENT DE L'ACNE (Use of adapalene for the preparation of composition to be administered in combination/in association with benzoyl peroxide for reducing the number of acne injuries such as inflammatory and/or non-inflammatory type)
Estimated Expiration: ⤷ Sign Up

Hungary

Patent: 43502
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 09542779
Estimated Expiration: ⤷ Sign Up

Patent: 14040481
Patent: COMBINATIONS OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷ Sign Up

Patent: 16029094
Patent: 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)
Estimated Expiration: ⤷ Sign Up

Lithuania

Patent: 50035
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 09000319
Patent: COMBINACION DE ADAPALENO Y PEROXIDO DE BENZOILO PARA TRATAMIENTO DE LESIONES DEL ACNE. (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS.)
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 46318
Estimated Expiration: ⤷ Sign Up

Patent: 50035
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 46318
Estimated Expiration: ⤷ Sign Up

Patent: 50035
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 09104949
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
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Patent: 12136952
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
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Patent: 12144414
Patent: КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 46318
Estimated Expiration: ⤷ Sign Up

Patent: 50035
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 090028764
Patent: COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷ Sign Up

Patent: 150003917
Patent: COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS
Estimated Expiration: ⤷ Sign Up

Patent: 160120352
Patent: 여드름 병변 치료를 위한 아다팔렌 및 벤조일 퍼옥시드의 조합물 (COMBINATION OF ADAPALENE AND BENZOYL PEROXIDE FOR TREATING ACNE LESIONS)
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Spain

Patent: 23951
Estimated Expiration: ⤷ Sign Up

Patent: 03505
Estimated Expiration: ⤷ Sign Up

Turkey

Patent: 1819658
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Argentina	065085	METODO PARA TRATAMIENTO PROLONGADO DEL ACNE VULGARIS	⤷ Sign Up
Croatia	P20150940		⤷ Sign Up
Poland	216763		⤷ Sign Up
European Patent Office	2046318	Combinaison d'adapalène et de peroxyde de benzoyle pour le traitement de lésions inflammatoires de l'acné (Combination of adapalene and benzoyl peroxide for treating inflammatory acne lesions)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EPIDUO FORTE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	132008901685368	Italy	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
1458369	SZ 31/2008	Austria	⤷ Sign Up	PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
1458369	122008000041	Germany	⤷ Sign Up	PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for EPIDUO FORTE

Recent Clinical Trials for EPIDUO FORTE

Pharmacology for EPIDUO FORTE

Paragraph IV (Patent) Challenges for EPIDUO FORTE

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

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