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Last Updated: March 29, 2024

DIFFERIN Drug Patent Profile


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When do Differin patents expire, and what generic alternatives are available?

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

This drug has fifty-six patent family members in twenty-two countries.

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

DrugPatentWatch® 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Wake Forest University Health SciencesEarly Phase 1
Bausch Health Americas, Inc.Early Phase 1
Aurobindo Pharma LtdPhase 3

See all DIFFERIN clinical trials

Pharmacology for DIFFERIN
Drug ClassRetinoid
Paragraph IV (Patent) Challenges for DIFFERIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DIFFERIN Topical Gel adapalene 0.30% 021753 1 2009-09-15

US Patents and Regulatory Information for DIFFERIN

DIFFERIN is protected by five US patents.

Patents protecting DIFFERIN

Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS

Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ACNE

Cosmetic/dermatological compositions comprising naphtholic acid compounds and polyurethane polymers
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ACNE

Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ACNE

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene LOTION;TOPICAL 022502-001 Mar 17, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 020380-002 Jul 8, 2016 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene LOTION;TOPICAL 022502-001 Mar 17, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DIFFERIN

See the table below for patents covering DIFFERIN around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 0199636 BENZONAPHTHALENIC DERIVATIVES, PROCESS FOR THEIR PREPARATION AND THEIR USE IN PHARMACY AND COSMETICS ⤷  Try a Trial
Norway 170627 ⤷  Try a Trial
Finland 87762 ⤷  Try a Trial
Brazil 0307550 Uso do ácido 6-[3-(1-adamantil)-4-metoxifenil]-2-naftanóico e composição farmacêutica ⤷  Try a Trial
China 104013540 Composition comprising at least one naphthoic acid derivative and at least one compound of polyurethane polymer type or derivatives thereof, preparation processes therefor and uses thereof ⤷  Try a Trial
Slovenia 1532974 ⤷  Try a Trial
Denmark 162286 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DIFFERIN

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