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Serving leading biopharmaceutical companies globally:

Fuji
Merck
Federal Trade Commission
Dow
McKesson
AstraZeneca
Teva
US Army
Fish and Richardson
Express Scripts

Generated: December 12, 2017

DrugPatentWatch Database Preview

DIFFERIN Drug Profile

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Which patents cover Differin, and what generic alternatives are available?

Differin is a drug marketed by Galderma Labs Lp and is included in five NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-five patent family members in twenty-two countries and two supplementary protection certificates in two countries.

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

Pharmacology for DIFFERIN

Ingredient-typeRetinoids
Drug ClassRetinoid

Medical Subject Heading (MeSH) Categories for DIFFERIN

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 LpDIFFERINadapaleneCREAM;TOPICAL020748-001May 26, 2000ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneGEL;TOPICAL021753-001Jun 19, 2007ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneGEL;TOPICAL021753-001Jun 19, 2007ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Galderma Labs LpDIFFERINadapaleneSOLUTION;TOPICAL020338-001May 31, 1996DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneGEL;TOPICAL021753-001Jun 19, 2007ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneGEL;TOPICAL020380-002Jul 8, 2016OTCYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneGEL;TOPICAL021753-001Jun 19, 2007ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Galderma Labs LpDIFFERINadapaleneGEL;TOPICAL021753-001Jun 19, 2007ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneGEL;TOPICAL021753-001Jun 19, 2007ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneLOTION;TOPICAL022502-001Mar 17, 2010RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: DIFFERIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs LpDIFFERINadapaleneSOLUTION;TOPICAL020338-001May 31, 1996► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneCREAM;TOPICAL020748-001May 26, 2000► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneGEL;TOPICAL021753-001Jun 19, 2007► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneGEL;TOPICAL021753-001Jun 19, 2007► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneSOLUTION;TOPICAL020338-001May 31, 1996► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneCREAM;TOPICAL020748-001May 26, 2000► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for DIFFERIN

Drugname Dosage Strength RLD Submissiondate
adapaleneTopical Gel0.30%Differin9/15/2009

Non-Orange Book Patents for Tradename: DIFFERIN

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
8,653,140Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
9,622,994Method for the treatment of acne using pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid► Subscribe
9,381,179Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
9,387,187Administration of 6[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
8,921,423Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid► Subscribe
8,729,127Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► 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: DIFFERIN

Country Document Number Estimated Expiration
Canada2622468► Subscribe
Australia2008203279► Subscribe
South Africa200405853► Subscribe
MexicoPA04008684► Subscribe
European Patent Office1933827► Subscribe
Austria417610► Subscribe
Slovenia1532974► Subscribe
World Intellectual Property Organization (WIPO)2007031883► Subscribe
Hong Kong1073996► Subscribe
Canada2478237► 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: DIFFERIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB10/005United Kingdom► SubscribePRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
C0024France► SubscribePRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Cipla
AstraZeneca
Citi
Cerilliant
Chinese Patent Office
Baxter
Dow
Merck

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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