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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Chinese Patent Office
Queensland Health
Express Scripts
Cantor Fitzgerald
McKinsey
Accenture
Novartis
Deloitte

Generated: January 19, 2018

DrugPatentWatch Database Preview

Adapalene - Generic Drug Details

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What are the generic sources for adapalene and what is the scope of adapalene freedom to operate?

Adapalene
is the generic ingredient in five branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Glenmark Generics, Pliva Hrvatska Doo, Taro, Tolmar, Call Inc, and Galderma Labs, and is included in sixteen NDAs. There are twenty-three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Adapalene has fifty-five patent family members in twenty-two countries.

There are twelve drug master file entries for adapalene. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for adapalene
Ingredient-typeRetinoids
Drug ClassRetinoid
Medical Subject Heading (MeSH) Categories for adapalene
Tentative approvals for ADAPALENE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe1%;2%GEL;TOPICAL

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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Glenmark Generics ADAPALENE adapalene GEL;TOPICAL 091314-001 Jul 1, 2010 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Taro ADAPALENE adapalene GEL;TOPICAL 208322-001 Jun 23, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Non-Orange Book US Patents for adapalene

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,387,187 Administration of 6[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders ➤ Subscribe
8,653,140 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders ➤ Subscribe
8,729,127 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders ➤ Subscribe
9,622,994 Method for the treatment of acne using pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid ➤ Subscribe
9,381,179 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders ➤ Subscribe
8,921,423 Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for adapalene

Supplementary Protection Certificates for adapalene

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB10/005 United Kingdom ➤ Subscribe PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
C0024 France ➤ Subscribe PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Argus Health
Colorcon
Cerilliant
QuintilesIMS
US Department of Justice
Daiichi Sankyo
McKinsey
McKesson
Baxter

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 verifification 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.

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