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Generated: September 21, 2017

DrugPatentWatch Database Preview

ADAPALENE; BENZOYL PEROXIDE - Generic Drug Details

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

Adapalene; benzoyl peroxide
is the generic ingredient in three branded drugs marketed by Galderma Labs, Galderma Labs Lp, and Actavis Mid Atlantic, 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 ninety-eight patent family members in twenty-five countries.

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

Summary for Generic Name: ADAPALENE; BENZOYL PEROXIDE

Tradenames:3
Patents:15
Applicants:3
NDAs:3
Drug Master File Entries: see list11
Suppliers / Packagers: see list4
Clinical Trials: see list157
Drug Prices:see low prices
DailyMed Link:ADAPALENE; BENZOYL PEROXIDE at DailyMed

Pharmacology for Ingredient: ADAPALENE; BENZOYL PEROXIDE

Ingredient-typeRetinoids
Drug ClassRetinoid
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;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Actavis Mid Atlantic
ADAPALENE AND BENZOYL PEROXIDE
adapalene; benzoyl peroxide
GEL;TOPICAL203790-001Sep 30, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► 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 Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008► Subscribe► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;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
7,579,377Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
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
7,838,558Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
7,834,060Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic 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
7,737,181Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
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
8,653,140Administration 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
Japan2016029094► Subscribe
European Patent Office2450035► Subscribe
World Intellectual Property Organization (WIPO)03055472► Subscribe
Australia2008203279► Subscribe
Russian Federation2377981► Subscribe
Austria417610► Subscribe
France2837101► Subscribe
Argentina038924► Subscribe
Denmark2114392► Subscribe
Slovenia2114392► 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
1458369/01Switzerland► SubscribePRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
C0024France► SubscribePRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
0Finland► Subscribe
31/2008Austria► SubscribePRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
2008 00029Denmark► Subscribe
C/GB10/005United Kingdom► SubscribePRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
2008000041Germany► SubscribePRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
Daiichi Sankyo
Chinese Patent Office
Boehringer Ingelheim
Moodys
Dow
Chubb
Healthtrust
Cipla
Fuji

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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