Adapalene - Generic Drug Details

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, Encube Ethicals, Glenmark Generics, P And L, Taro, Taro Pharms, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, Zydus Pharms, and Galderma Labs, and is included in twenty-seven 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-six suppliers are listed for this compound.

Summary for adapalene

International Patents:	56
US Patents:	24
Tradenames:	5
Applicants:	16
NDAs:	27
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	79
Patent Applications:	6,252
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
University of Oklahoma	Phase 3
Dr.dr.Irma Bernadette, SpKK (K)	Phase 1
Jonathan M Towarnicki	Early Phase 1

See all adapalene clinical trials

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	Strength	NDA	ANDAs Submitted	Submissiondate
DIFFERIN	Topical Gel	adapalene	0.30%	021753	1	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
P And L	ADAPALENE	adapalene	GEL;TOPICAL	090962-001	Jun 2, 2010		OTC	No	No
Glenmark Pharms Ltd	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	208108-001	Nov 8, 2019	AB	RX	No	No

Expired US Patents for adapalene

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	CREAM;TOPICAL	020748-001	May 26, 2000

International Patents for adapalene

Country	Patent Number	Title	Estimated Expiration
France	2890861	COMPOSITIONS COMPRENANT AU MOINS UN DERIVE DE L'ACIDE NAPHTOIQUE ET AU MOINS UN COMPOSE DE TYPE POLYMERES DE POLYURETHANES OU DES DERIVES DE CELUI-CI, LEURS PROCEDE DE PREPARATION, ET LEUR UTILISATION (Composition, useful to treat and/or prevent e.g. dermatological diseases, acne necrotic, acne neonatorum, comprises naphthoic acid derivative and polyurethane type polymer)
Russian Federation	2008114840	КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ПО МЕНЬШЕЙ МЕРЕ ОДНО ПРОИЗВОДНОЕ НАФТОЕВОЙ КИСЛОТЫ И ПО МЕНЬШЕЙ МЕРЕ ОДНО СОЕДИНЕНИЕ ТИПА ПОЛИУРЕТАНОВОГО ПОЛИМЕРА ИЛИ ЕГО ПРОИЗВОДНОЕ, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ
Poland	372317	Zastosowanie kwasu 6-[3-(1-adamantylo)-4-metoksyfenylo]-2-naftalenokarboksylowego (USE OF ADAPALENE FOR THE TREATMENT OF DERMATOLOGICAL DISORDERS)

Supplementary Protection Certificates for adapalene

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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