.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

► See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving 500+ biopharmaceutical companies globally:

Cipla
Colorcon
Merck
AstraZeneca
Queensland Health
Cerilliant
Healthtrust
Deloitte
Moodys
Johnson and Johnson

Generated: September 25, 2017

DrugPatentWatch Database Preview

EPIDUO FORTE Drug Profile

« Back to Dashboard

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 ninety-six 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 Tradename: EPIDUO FORTE

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list1
Clinical Trials: see list72
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EPIDUO FORTE at DailyMed

Pharmacology for Tradename: EPIDUO FORTE

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
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV (Patent) Challenges for EPIDUO FORTE

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

Non-Orange Book Patents for Tradename: 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
8,071,644Combinations of adapalene and benzoyl peroxide for treating acne lesions► Subscribe
7,964,202Method for treatment of common acne► 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
8,653,140Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
7,838,558Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
8,105,618Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide► Subscribe
7,579,377Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
8,241,649Dermatological/cosmetic gels comprising at least one retinoid and/or retinoid salt and benzoyl peroxide► Subscribe
8,129,362Combination/association of adapalene and benzoyl peroxide for treating acne lesions► Subscribe
7,820,186Gel composition for once-daily treatment of common acne comprising a combination of benzoyl peroxide and adapalene and/or adapalene salt► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: EPIDUO FORTE

Country Document Number Estimated Expiration
South Korea20040111394► Subscribe
Germany60216634► Subscribe
Slovenia1485080► Subscribe
Canada2677167► Subscribe
Hungary0500006► Subscribe
Portugal2046318► Subscribe
Japan2011037904► Subscribe
Spain2275948► Subscribe
Russian Federation2009104949► Subscribe
Hong Kong1073996► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: EPIDUO FORTE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369/01Switzerland► SubscribePRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
2008000041Germany► SubscribePRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
C0024France► SubscribePRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
31/2008Austria► SubscribePRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
0Finland► Subscribe
2008 00029Denmark► Subscribe
C/GB10/005United Kingdom► SubscribePRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Dow
Deloitte
Healthtrust
Chubb
US Department of Justice
QuintilesIMS
Harvard Business School
Argus Health
Farmers Insurance
Chinese Patent Office

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot