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Last Updated: May 28, 2022

DIFFERIN Drug Patent 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-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. Twenty-five 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

See drug prices for DIFFERIN

Drug Sales Revenue Trends for DIFFERIN

See drug sales revenues for DIFFERIN

Recent Clinical Trials for DIFFERIN

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

SponsorPhase
Aurobindo Pharma LtdPhase 3
Taro Pharmaceuticals USAEarly Phase 1
Catawba Research, LLCPhase 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 nine US patents.

Patents protecting DIFFERIN

Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Cosmetic/dermatological compositions comprising naphtholic acid compounds and polyurethane polymers
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 020380-002 Jul 8, 2016 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 GEL;TOPICAL 021753-001 Jun 19, 2007 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 See Plans and Pricing See Plans and Pricing
>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
Australia 2008203279 Use of adapalene for the treatment of dermatological disorders See Plans and Pricing
South Korea 101007161 See Plans and Pricing
Japan 2011032287 PHARMACEUTICAL COMPOSITION COMPRISING ADAPALENE FOR TREATMENT OF DERMATOLOGICAL DISORDER See Plans and Pricing
Spain 554186 See Plans and Pricing
Spain 2319778 See Plans and Pricing
Australia 2003216898 USE OF ADAPALENE FOR THE TREATMENT OF DERMATOLOGICAL DISORDERS See Plans and Pricing
Japan 2012184258 COMPOSITION CONTAINING AT LEAST ONE DERIVATIVE OF NAPHTHOIC ACID AND AT LEAST ONE POLYURETHANE POLYMER TYPE COMPOUND OR DERIVATIVE THEREOF, PREPARATION METHOD, AND USE OF THE SAME See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DIFFERIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 08C0024 France See Plans and Pricing PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
1458369 132008901685368 Italy See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
0199636 300209 Netherlands See Plans and Pricing 300209, 20060411, EXPIRES: 20070702
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Mallinckrodt
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Medtronic
Boehringer Ingelheim
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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.