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Last Updated: April 23, 2024

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 six branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Alembic, Encube Ethicals, Glenmark Generics, P And L, Taro, Call Inc, Actavis Labs Ut Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, Zydus Pharms, Galderma Labs, and Bausch, and is included in twenty-eight NDAs. There are fifteen 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. Thirty-eight suppliers are listed for this compound.

Summary for adapalene

International Patents:	56
US Patents:	15
Tradenames:	6
Applicants:	16
NDAs:	28
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	81
Patent Applications:	5,616
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
Mansoura University	Phase 2
University of Oklahoma	Phase 3
Dr.dr.Irma Bernadette, SpKK (K)	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

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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 Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Mid Atlantic	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	203790-001	Sep 30, 2015		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	020380-002	Jul 8, 2016		OTC	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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

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

International Patents for adapalene

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Country	Patent Number	Title	Estimated Expiration
Mexico	2008003422	COMPOSICIONES QUE COMPRENDEN AL MENOS UN DERIVADO DE ACIDO NAFTOICO Y AL MENOS UN COMPUESTO DE TIPO POLIMERO DE POLIURETANO O DERIVADOS DEL MISMO, PROCESOS DE PREPARACION Y COMPOSICIONES QUE COMPRENDEN AL MENOS UN DERIVADO DE ACIDO NAFTOICO Y AL MENO (COMPOSITION COMPRISING AT LEAST ONE NAPHTHOIC ACID DERIVATIVE AND AT LEAST ONE COMPOUND OF POLYURETHANE POLYMER TYPE OR DERIVATIVES THEREOF, PREPARATION PROCESSES THEREFOR AND USES THEREOF.)	⤷ Try a Trial
Hong Kong	1073996	USE OF ADAPALENE FOR THE TREATMENT OF DERMATOLOGICAL DISORDERS	⤷ Try a Trial
Denmark	1532974		⤷ Try a Trial
Brazil	PI0307550	composição farmacêutica em gel tópica, de adapaleno 0,3%	⤷ Try a Trial
Mexico	PA04008684	USO DE ADAPALENO PARA TRATAMIENTO DE TRASTORNOS DERMATOLOGICOS. (USE OF ADAPALENE FOR THE TREATMENT OF DERMATOLOGICAL DISORDERS.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for adapalene

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	08C0024	France	⤷ Try a Trial	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	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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