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Serving leading biopharmaceutical companies globally:

Covington
Queensland Health
McKinsey
Accenture
Merck
McKesson
Dow
Federal Trade Commission
Baxter
Fish and Richardson

Generated: February 23, 2018

DrugPatentWatch Database Preview

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, Perrigo Israel, Taro, Galderma Labs Lp, and Galderma Labs, and is included in five NDAs. There are sixteen 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 eleven patent family members in twenty-five countries.

There are twelve drug master file entries for adapalene; benzoyl peroxide. Six suppliers are listed for this compound.
Summary for adapalene; benzoyl peroxide
International Patents:111
US Patents:16
Tradenames:3
Applicants:5
NDAs:5
Drug Master File Entries: 12
Suppliers / Packagers: 6
Clinical Trials: 161
Drug Prices:see low prices
DailyMed Link:adapalene; benzoyl peroxide at DailyMed
Pharmacology for adapalene; benzoyl peroxide
Ingredient-typeRetinoids
Drug ClassRetinoid

US Patents and Regulatory Information for adapalene; benzoyl peroxide

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;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taro ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 206959-001 Jan 24, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Mid Atlantic ADAPALENE AND BENZOYL PEROXIDE adapalene; benzoyl peroxide GEL;TOPICAL 203790-001 Sep 30, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Expired US Patents for adapalene; benzoyl peroxide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 ➤ Sign Up ➤ Sign Up
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
7,579,377 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders ➤ Sign Up
7,838,558 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders ➤ Sign Up
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 ➤ Sign Up
8,921,423 Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid ➤ Sign Up
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 ➤ Sign Up
8,653,140 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders ➤ Sign Up
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 ➤ Sign Up
9,872,842 ➤ Sign Up
7,834,060 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for adapalene; benzoyl peroxide

Supplementary Protection Certificates for adapalene; benzoyl peroxide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0 Finland ➤ Sign Up
C/GB10/005 United Kingdom ➤ Sign Up PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
2008 00029 Denmark ➤ Sign Up PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369/01 Switzerland ➤ Sign Up PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
31/2008 Austria ➤ Sign Up PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
C0024 France ➤ Sign Up PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
2008000041 Germany ➤ Sign Up PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Colorcon
Baxter
Cipla
Queensland Health
Fish and Richardson
US Army
Express Scripts

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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