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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Daiichi Sankyo
Harvard Business School
Fish and Richardson
AstraZeneca
Cantor Fitzgerald
Express Scripts
QuintilesIMS
Novartis

Generated: December 12, 2017

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Adapalene; benzoyl peroxide - Generic Drug Details

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

Adapalene; benzoyl peroxide
is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Galderma Labs Lp, and Galderma Labs, and is included in three NDAs. There are fifteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Adapalene; benzoyl peroxide has one hundred and thirteen patent family members in twenty-five countries and seven supplementary protection certificates in seven countries.

There are eleven drug master file entries for adapalene; benzoyl peroxide. Four suppliers are listed for this compound.

Summary for adapalene; benzoyl peroxide

Pharmacology for adapalene; benzoyl peroxide

Ingredient-typeRetinoids
Drug ClassRetinoid
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Galderma Labs LpEPIDUOadapalene; benzoyl peroxideGEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma Labs LpEPIDUOadapalene; benzoyl peroxideGEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Galderma Labs LpEPIDUOadapalene; benzoyl peroxideGEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma Labs LpEPIDUOadapalene; benzoyl peroxideGEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Actavis Mid AtlanticADAPALENE AND BENZOYL PEROXIDEadapalene; benzoyl peroxideGEL;TOPICAL203790-001Sep 30, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: adapalene; benzoyl peroxide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs LpEPIDUOadapalene; benzoyl peroxideGEL;TOPICAL022320-001Dec 8, 2008► Subscribe► Subscribe
Galderma Labs LpEPIDUOadapalene; benzoyl peroxideGEL;TOPICAL022320-001Dec 8, 2008► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: adapalene; benzoyl peroxide

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
7,868,044Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid► Subscribe
9,814,690Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt► Subscribe
8,653,140Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
8,921,423Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid► Subscribe
7,838,558Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
7,737,181Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
9,622,994Method for the treatment of acne using pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid► Subscribe
7,834,060Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders► Subscribe
7,579,377Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: adapalene; benzoyl peroxide

Country Document Number Estimated Expiration
Australia2003216898► Subscribe
Russian Federation2012144414► Subscribe
South Africa200405853► Subscribe
Japan2011032287► Subscribe
Hungary0500006► Subscribe
Cyprus1116672► Subscribe
Austria417610► Subscribe
Japan2005526063► Subscribe
Japan5722598► Subscribe
Hong Kong1073996► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ADAPALENE; BENZOYL PEROXIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
31/2008Austria► SubscribePRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
C0024France► SubscribePRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
C/GB10/005United Kingdom► SubscribePRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
2008 00029Denmark► Subscribe
1458369/01Switzerland► SubscribePRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
2008000041Germany► SubscribePRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
0Finland► Subscribe
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Serving leading biopharmaceutical companies globally:

Medtronic
Federal Trade Commission
McKinsey
AstraZeneca
McKesson
Merck
Deloitte
Accenture
QuintilesIMS
Healthtrust

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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