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DIFFERIN Drug Profile

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

This drug has forty-nine patent family members in twenty-two countries.

The generic ingredient in DIFFERIN is adapalene. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the adapalene profile page.

Summary for Tradename: DIFFERIN

Patents:9
Applicants:1
NDAs:5
Suppliers / Packagers: see list4

Pharmacology for Tradename: DIFFERIN

Ingredient-typeRetinoids
Drug ClassRetinoid

Clinical Trials for: DIFFERIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp
DIFFERIN
adapalene
LOTION;TOPICAL022502-001Mar 17, 2010RXYes7,998,467<disabled>Y <disabled>
Galderma Labs Lp
DIFFERIN
adapalene
GEL;TOPICAL021753-001Jun 19, 2007RXYes7,834,060<disabled> <disabled>
Galderma Labs Lp
DIFFERIN
adapalene
SOLUTION;TOPICAL020338-001May 31, 1996DISCNNo<disabled><disabled>
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Expired Patents for Tradename: DIFFERIN

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
DIFFERIN
adapalene
GEL;TOPICAL021753-001Jun 19, 2007RE34440<disabled>
Galderma Labs Lp
DIFFERIN
adapalene
SOLUTION;TOPICAL020338-001May 31, 1996RE34440<disabled>
Galderma Labs Lp
DIFFERIN
adapalene
CREAM;TOPICAL020748-001May 26, 20004,717,720<disabled>
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Paragraph IV activity 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<disabled in preview>
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<disabled in preview>
8,729,127Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders<disabled in preview>
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International Patent Family for Tradename: DIFFERIN

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2007031883<disabled in preview>
Japan2009508843<disabled in preview>
China1642538<disabled in preview>
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Supplementary Protection Certificates for Tradename: DIFFERIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB10/005United Kingdom<disabled>PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
C0024France<disabled>PRODUCT 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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