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 Pharms Inc, 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. Forty 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:	40
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	82
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
HITEC-Institute of Medical Sciences	N/A
Mansoura University	Phase 2
University of Oklahoma	Phase 3

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	DIFFERIN	adapalene	LOTION;TOPICAL	022502-001	Mar 17, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Call Inc	ADAPALENE	adapalene	SOLUTION;TOPICAL	203981-001	Sep 23, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch	CABTREO	adapalene; benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	216632-001	Oct 20, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glenmark Pharms Ltd	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	208108-001	Nov 8, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	⤷ Sign Up	⤷ Sign Up
>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
Cyprus	1109307		⤷ Sign Up
Japan	5722598		⤷ Sign Up
Poland	216763		⤷ Sign Up
European Patent Office	1532974	Composition comprenant de l'acide 6-[3-(1-adamantyl)-4-méthoxyphényl]-2-naphthanoique pour le traitement de troubles dermatologiques (Composition comprising 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders)	⤷ Sign Up
Portugal	1532974		⤷ Sign Up
>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	SPC/GB10/005	United Kingdom	⤷ Sign Up	PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369	132008901685368	Italy	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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