DIFFERIN Drug Patent 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 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. Forty 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 2^nd, 2010.

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Summary for DIFFERIN

International Patents:	56
US Patents:	5
Applicants:	1
NDAs:	5
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	22
Patent Applications:	4,034
Drug Prices:	Drug price information for DIFFERIN
Drug Sales Revenues:	Drug sales revenues for DIFFERIN
What excipients (inactive ingredients) are in DIFFERIN?	DIFFERIN excipients list
DailyMed Link:	DIFFERIN at DailyMed

Drug patent expirations by year for DIFFERIN

Recent Clinical Trials for DIFFERIN

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

Sponsor	Phase
Bausch Health Americas, Inc.	Early Phase 1
Wake Forest University Health Sciences	Early Phase 1
Aurobindo Pharma Ltd	Phase 3

See all DIFFERIN clinical trials

Pharmacology for DIFFERIN

Drug Class	Retinoid

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	LOTION;TOPICAL	022502-001	Mar 17, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	020380-002	Jul 8, 2016		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	LOTION;TOPICAL	022502-001	Mar 17, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1933827	COMPOSITION CONTENANT AU MOINS UN DERIVE D'ACIDE NAPHTOIQUE ET AU MOINS UN COMPOSE DE TYPE POLYMERE DE POLYURETHANE OU DES DERIVES DE CE COMPOSE, PROCEDES DE FABRICATION ET UTILISATIONS DE CETTE COMPOSITION (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)	⤷ Sign Up
Russian Federation	2004130308	ПРИМЕНЕНИЕ 6-[3-(1-АДАМАНТИЛ)-4-МЕТОКСИФЕНИЛ]-2-НАФТОЙНОЙ КИСЛОТЫ ДЛЯ ЛЕЧЕНИЯ ДЕРМАТОЛОГИЧЕСКИХ РАССТРОЙСТВ	⤷ Sign Up
Japan	5074401		⤷ Sign Up
Australia	2006290364	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	⤷ Sign Up
Hong Kong	1073996	USE OF ADAPALENE FOR THE TREATMENT OF DERMATOLOGICAL DISORDERS	⤷ Sign Up
Spain	2319778		⤷ Sign Up
Germany	60327745		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DIFFERIN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0199636	300209	Netherlands	⤷ Sign Up	300209, 20060411, EXPIRES: 20070702
1458369	SPC/GB10/005	United Kingdom	⤷ Sign Up	PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369	132008901685368	Italy	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description