ADAPALENE - Generic Drug Details

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What are the generic drug sources for adapalene and what is the scope of patent protection?

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	GEL;TOPICAL	020380-002	Jul 8, 2016		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	ADAPALENE	adapalene	GEL;TOPICAL	208322-001	Jun 23, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Inc	ADAPALENE	adapalene	GEL;TOPICAL	091314-001	Jul 1, 2010		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	ADAPALENE	adapalene	GEL;TOPICAL	215940-001	Jan 14, 2022		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Ut Inc	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	209641-001	Jun 22, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Encube	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	206164-001	May 23, 2018	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	CREAM;TOPICAL	020748-001	May 26, 2000	⤷ 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
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
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996	⤷ 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
Brazil	PI0307550	composição farmacêutica em gel tópica, de adapaleno 0,3%	⤷ Sign Up
Russian Federation	2332208	ПРИМЕНЕНИЕ 6-[3-(1-АДАМАНТИЛ)-4-МЕТОКСИФЕНИЛ]-2-НАФТОЙНОЙ КИСЛОТЫ ДЛЯ ЛЕЧЕНИЯ ДЕРМАТОЛОГИЧЕСКИХ РАССТРОЙСТВ (APPLICATION OF 6-[3-(1-ADAMANTYL)-4-METHOXYPHENYL]-2-NAPHTHOIC ACID FOR DERMATOLOGICAL DISORDER TREATMENT)	⤷ Sign Up
Russian Federation	2008118056	ПРИМЕНЕНИЕ 6-[3-(1-АДАМАНТИЛ)-4-МЕТОКСИФЕНИЛ]-2-НАФТОЙНОЙ КИСЛОТЫ ДЛЯ ЛЕЧЕНИЯ ДЕРМАТОЛОГИЧЕСКИХ РАССТРОЙСТВ	⤷ Sign Up
South Africa	200405853	Use of adapalene for the treatment of dermatological disorders	⤷ Sign Up
Russian Federation	2377981	ПРИМЕНЕНИЕ 6-[3-(1-АДАМАНТИЛ)-4-МЕТОКСИФЕНИЛ]-2-НАФТОЙНОЙ КИСЛОТЫ ДЛЯ ЛЕЧЕНИЯ ДЕРМАТОЛОГИЧЕСКИХ РАССТРОЙСТВ (APPLICATION OF 6-[3(1-ADAMANTYL)-4-METHOXYPHENYL]-2-NAPHTHOIC ACID FOR TREATING DERMATOLOGICAL DISORDER)	⤷ Sign Up
Australia	2008203279	Use of adapalene for the treatment of dermatological disorders	⤷ Sign Up
Brazil	0307550	Uso do ácido 6-[3-(1-adamantil)-4-metoxifenil]-2-naftanóico e composição farmacêutica	⤷ 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.