Adapalene; benzoyl peroxide - Generic Drug Details

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What are the generic sources for adapalene; benzoyl peroxide and what is the scope of patent protection?

Adapalene; benzoyl peroxide is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Encube, Glenmark Pharms Ltd, Padagis Israel, Taro, Galderma Labs Lp, and Galderma Labs, and is included in eight NDAs. There are sixteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Adapalene; benzoyl peroxide has one hundred and twenty-three patent family members in twenty-seven countries.

Nine suppliers are listed for this compound.

Summary for adapalene; benzoyl peroxide

International Patents:	123
US Patents:	16
Tradenames:	3
Applicants:	7
NDAs:	8
Finished Product Suppliers / Packagers:	9
Clinical Trials:	40
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for adapalene; benzoyl peroxide
DailyMed Link:	adapalene; benzoyl peroxide at DailyMed

Recent Clinical Trials for adapalene; benzoyl peroxide

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

Sponsor	Phase
Mahidol University	Phase 2
Beiersdorf	Phase 2
Vichy Laboratoires	Phase 4

See all adapalene; benzoyl peroxide clinical trials

Pharmacology for adapalene; benzoyl peroxide

Drug Class	Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for adapalene; benzoyl peroxide

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 ADAPALENE; BENZOYL PEROXIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPIDUO FORTE	Gel	adapalene; benzoyl peroxide	0.3%/2.5%	207917	1	2016-05-04
EPIDUO	Gel	adapalene; benzoyl peroxide	0.1%/2.5%	022320	1	2011-12-30

US Patents and Regulatory Information for adapalene; benzoyl peroxide

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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	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	AB	RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
>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 adapalene; benzoyl peroxide

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

International Patents for adapalene; benzoyl peroxide

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Country	Patent Number	Title	Estimated Expiration
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)	See Plans and Pricing
Russian Federation	2012144414	КОМБИНАЦИЯ АДАПАЛЕНА И ПЕРОКСИДА БЕНЗОИЛА ДЛЯ ЛЕЧЕНИЯ ПОРАЖЕНИЙ АКНЕ	See Plans and Pricing
Turkey	201819658		See Plans and Pricing
China	1642538	Use of adapalene for the treatment of dermatological disorders	See Plans and Pricing
Poland	2450035		See Plans and Pricing
Denmark	1485080		See Plans and Pricing
Poland	220838		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for adapalene; benzoyl peroxide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	08C0024	France	See Plans and Pricing	PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
1458369	122008000041	Germany	See Plans and Pricing	PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369	SPC/GB10/005	United Kingdom	See Plans and Pricing	PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369	380	Finland	See Plans and Pricing
1458369	132008901685368	Italy	See Plans and Pricing	PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618
1458369	CA 2008 00029	Denmark	See Plans and Pricing	PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369	C01458369/01	Switzerland	See Plans and Pricing	PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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