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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Medtronic
Moodys
Fish and Richardson
Farmers Insurance
Harvard Business School
Express Scripts
Mallinckrodt
Accenture

Generated: January 18, 2018

DrugPatentWatch Database Preview

EPIDUO FORTE Drug Profile

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Which patents cover Epiduo Forte, and when can generic versions of Epiduo Forte launch?

Epiduo Forte is a drug marketed by Galderma Labs and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eleven patent family members in twenty-five countries.

The generic ingredient in EPIDUO FORTE 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.
Summary for EPIDUO FORTE
Drug patent expirations by year for EPIDUO FORTE
Pharmacology for EPIDUO FORTE
Ingredient-typeRetinoids
Drug ClassRetinoid

US Patents and Regulatory Information for EPIDUO FORTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ 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 EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 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
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ 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 EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ 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 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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Paragraph IV (Patent) Challenges for EPIDUO FORTE
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Gel 0.3%/2.5% ➤ Subscribe 5/4/2016

Non-Orange Book US Patents for EPIDUO FORTE

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
7,737,181 Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders ➤ Subscribe
9,622,994 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
8,071,644 Combinations of adapalene and benzoyl peroxide for treating acne lesions ➤ Subscribe
7,868,044 Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid ➤ Subscribe
8,241,649 Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide ➤ Subscribe
8,105,618 Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide ➤ Subscribe
7,820,186 Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt ➤ Subscribe
9,814,690 Gel composition for treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt ➤ Subscribe
8,080,537 Combinations of adapalene and benzoyl peroxide for treating acne lesions ➤ Subscribe
7,834,060 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for EPIDUO FORTE

Supplementary Protection Certificates for EPIDUO FORTE

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
1458369/01 Switzerland ➤ Subscribe PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
2008 00029 Denmark ➤ Subscribe
2008000041 Germany ➤ Subscribe PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
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
31/2008 Austria ➤ Subscribe PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
0 Finland ➤ Subscribe
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
McKinsey
QuintilesIMS
Cerilliant
Federal Trade Commission
Fish and Richardson
US Department of Justice
US Army

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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