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Adapalene - Generic Drug Details

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What are the generic sources for adapalene and what is the scope of freedom to operate?

Adapalene is the generic ingredient in five branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Aleor Dermaceuticals, Glenmark Generics, P And L, Taro, Tolmar, Call Inc, Glenmark Pharms Ltd, Perrigo Uk Finco, and Galderma Labs, and is included in twenty-two NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Adapalene has fifty-five patent family members in twenty-two countries.

There are twelve drug master file entries for adapalene. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for adapalene

International Patents:	55
US Patents:	24
Tradenames:	5
Applicants:	12
NDAs:	22
Drug Master File Entries:	12
Suppliers / Packagers:	20
Bulk Api Vendors:	119
Clinical Trials:	70
Patent Applications:	4,256
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for adapalene
Drug Sales Revenues:	Drug sales revenues for adapalene
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for adapalene
DailyMed Link:	adapalene at DailyMed

See drug prices for adapalene

See drug sales revenues for adapalene

Recent Clinical Trials for adapalene

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

Sponsor	Phase
Aurobindo Pharma Ltd	Phase 3
Assiut University	Phase 4
Foamix Ltd.	Phase 2

See all adapalene clinical trials

Generic filers with tentative approvals for ADAPALENE

Applicant	Application No.	Strength	Dosage Form
		0.3%;2.5%	GEL; TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for adapalene

Drug Class

Retinoid

Medical Subject Heading (MeSH) Categories for adapalene

Anti-Inflammatory Agents, Non-Steroidal

Dermatologic Agents

Paragraph IV (Patent) Challenges for ADAPALENE

Tradename	Dosage	Ingredient	NDA	Submissiondate
DIFFERIN	GEL;TOPICAL	adapalene	021753	2009-09-15

US Patents and Regulatory Information for adapalene

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 Lp	DIFFERIN	adapalene	LOTION;TOPICAL	022502-001	Mar 17, 2010		RX	Yes	Yes			Y
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	AB	RX	Yes	Yes			Y
Galderma Labs Lp	DIFFERIN	adapalene	LOTION;TOPICAL	022502-001	Mar 17, 2010		RX	Yes	Yes			Y
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes

Expired US Patents for adapalene

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007

International Patents for adapalene

Country	Patent Number	Estimated Expiration
Poland	216763
Germany	60325379
South Korea	20080050579
Cyprus	1108868
Mexico	2008003422

Supplementary Protection Certificates for adapalene

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	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