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Last Updated: July 4, 2020

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DIFFERIN Drug Profile


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

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.

The generic ingredient in DIFFERIN is adapalene. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the adapalene profile page.

US ANDA Litigation and Generic Entry Outlook for Differin

A generic version of DIFFERIN was approved as adapalene by P AND L on June 2nd, 2010.

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Drug patent expirations by year for DIFFERIN
Drug Prices for DIFFERIN

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Drug Sales Revenue Trends for DIFFERIN

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Recent Clinical Trials for DIFFERIN

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SponsorPhase
Aurobindo Pharma LtdPhase 3
Aleor Dermaceuticals LimitedPhase 3
Catawba Research, LLCPhase 3

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Pharmacology for DIFFERIN
Drug ClassRetinoid
Paragraph IV (Patent) Challenges for DIFFERIN
Tradename Dosage Ingredient NDA Submissiondate
DIFFERIN GEL;TOPICAL adapalene 021753 2009-09-15

US Patents and Regulatory Information for DIFFERIN

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 DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DIFFERIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996   Start Trial   Start Trial
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000   Start Trial   Start Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007   Start Trial   Start Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007   Start Trial   Start Trial
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DIFFERIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 08C0024 France   Start Trial PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
0199636 300209 Netherlands   Start Trial 300209, 20060411, EXPIRES: 20070702
1458369 132008901685368 Italy   Start Trial PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618
1458369 SPC/GB10/005 United Kingdom   Start Trial PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Mallinckrodt
Colorcon
Medtronic
Boehringer Ingelheim
Merck

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