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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, Padagis Israel, 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-six patent family members in twenty-two countries.

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

Summary for adapalene

International Patents:	56
US Patents:	24
Tradenames:	5
Applicants:	12
NDAs:	22
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	74
Patent Applications:	6,448
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for adapalene
Drug Sales Revenues:	Drug sales revenues for adapalene
What excipients (inactive ingredients) are in adapalene?	adapalene excipients list
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
Edward Lain, MD	Phase 4
Vyne Therapeutics Inc.	Phase 4
Bausch Health Americas, Inc.	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

Anatomical Therapeutic Chemical (ATC) Classes for adapalene

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

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	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996		DISCN	Yes	No
Call Inc	ADAPALENE	adapalene	SOLUTION;TOPICAL	204593-001	Jan 5, 2016	AB	RX	No	No
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000	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		RX	Yes	Yes
Taro	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	206959-001	Jan 24, 2018	AB	RX	No	No
Galderma Labs Lp	DIFFERIN	adapalene	LOTION;TOPICAL	022502-001	Mar 17, 2010		RX	Yes	Yes			Y

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	GEL;TOPICAL	021753-001	Jun 19, 2007
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000

International Patents for adapalene

Country	Patent Number	Estimated Expiration
European Patent Office	1485080
Denmark	1532974
Austria	417610
Hong Kong	1073996
China	104013540
Portugal	1485080
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	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
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