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EPIDUO Drug Profile

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

This drug has fifty-nine patent family members in twenty-four countries.

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

Summary for Tradename: EPIDUO

Patents:15
Applicants:2
NDAs:2
Suppliers / Packagers: see list2
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: EPIDUO

Ingredient-typeRetinoids
Drug ClassRetinoid
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008RXYes7,964,202► subscribeY ► subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYes9,387,187► subscribe ► subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008RXYes8,809,305► subscribe ► subscribe
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Expired Patents for Tradename: EPIDUO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 20084,717,720► subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008RE34440► subscribe
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Paragraph IV activity 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
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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
Canada2466321► subscribe
Denmark2114392► subscribe
Argentina065085► 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
1458369/01Switzerland► subscribePRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
C/GB10/005United Kingdom► subscribePRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
0Finland► subscribe
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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 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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