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Serving leading biopharmaceutical companies globally:

US Army
Baxter
Express Scripts
Boehringer Ingelheim
Cerilliant
Julphar
Dow
Teva
Citi
Covington

Generated: December 15, 2017

DrugPatentWatch Database Preview

EPIDUO Drug Profile

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When do Epiduo patents expire, and when can generic versions of Epiduo launch?

Epiduo is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in two NDAs. There are fifteen patents protecting this drug and two Paragraph IV challenges.

This drug has seventy-five patent family members in twenty-four countries and seven supplementary protection certificates in seven countries.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the adapalene; benzoyl peroxide profile page.
Drug patent expirations by year for EPIDUO

Pharmacology for EPIDUO

Ingredient-typeRetinoids
Drug ClassRetinoid

US Patents and Regulatory Information

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► SubscribeY► Subscribe
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe► 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► Subscribe► Subscribe
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma Labs LpEPIDUOadapalene; benzoyl peroxideGEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► 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
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Galderma Labs LpEPIDUOadapalene; benzoyl peroxideGEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for EPIDUO

Drugname Dosage Strength RLD Submissiondate
adapalene and benzoyl peroxideGel0.3%/2.5%Epiduo Forte5/4/2016
adapalene and benzoyl peroxideGel0.1%/2.5%Epiduo12/30/2011

Non-Orange Book Patents for Tradename: EPIDUO

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
8,785,420Combination/association of adapalene and benzoyl peroxide for treating acne lesions► Subscribe
9,814,690Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt► 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 Tradename: EPIDUO

Country Document Number Estimated Expiration
Cyprus1116672► Subscribe
Cyprus1107583► Subscribe
Germany60216634► Subscribe
China1329025► Subscribe
Denmark2114392► Subscribe
Japan2009542779► Subscribe
Japan2005513146► Subscribe
Portugal2046318► Subscribe
South Korea20090028764► Subscribe
Spain2546029► 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: EPIDUO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008 00029Denmark► Subscribe
2008000041Germany► SubscribePRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
C/GB10/005United Kingdom► SubscribePRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
0Finland► Subscribe
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
1458369/01Switzerland► SubscribePRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Deloitte
US Army
Healthtrust
Colorcon
Mallinckrodt
Dow
Citi
Harvard Business School
AstraZeneca

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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