DIFFERIN Drug Patent Profile

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 2^nd, 2010.

Summary for DIFFERIN

International Patents:	56
US Patents:	9
Applicants:	1
NDAs:	5
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	21
Patent Applications:	5,111
Formulation / Manufacturing:	see details
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

See drug prices for DIFFERIN

See drug sales revenues for DIFFERIN

Recent Clinical Trials for DIFFERIN

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

Sponsor	Phase
Aurobindo Pharma Ltd	Phase 3
Taro Pharmaceuticals USA	Early Phase 1
Catawba Research, LLC	Phase 3

See all DIFFERIN clinical trials

Pharmacology for DIFFERIN

Drug Class

Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for DIFFERIN

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

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

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
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	AB	RX	Yes	Yes			Y
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	AB	RX	Yes	Yes
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996		DISCN	Yes	No
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	AB	RX	Yes	Yes			Y
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	020380-002	Jul 8, 2016		OTC	Yes	Yes
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	AB	RX	Yes	Yes

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
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007
Galderma Labs Lp	DIFFERIN	adapalene	SOLUTION;TOPICAL	020338-001	May 31, 1996
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000

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
South Korea	101007161
Japan	2011032287	PHARMACEUTICAL COMPOSITION COMPRISING ADAPALENE FOR TREATMENT OF DERMATOLOGICAL DISORDER
Spain	554186
Spain	2319778
Australia	2003216898	USE OF ADAPALENE FOR THE TREATMENT OF DERMATOLOGICAL DISORDERS
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

Supplementary Protection Certificates for DIFFERIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	08C0024	France		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		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		PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
0199636	300209	Netherlands		300209, 20060411, EXPIRES: 20070702