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ADAPALENE - Generic Drug Details

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What are the generic drug sources for adapalene and what is the scope of adapalene freedom to operate?

Adapalene is the generic ingredient in five branded drugs marketed by Fougera Pharms, Galderma Labs Lp, Actavis Mid Atlantic, Glenmark Generics, Pliva Hrvatska Doo, Taro, Tolmar, Call Inc, Perrigo Israel, and Galderma Labs, and is included in nineteen NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Adapalene has fifty-five patent family members in twenty-two countries.

There are twelve drug master file entries for adapalene. Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ADAPALENE

International Patents:	55
US Patents:	24
Tradenames:	5
Applicants:	10
NDAs:	19
Drug Master File Entries:	12
Suppliers / Packagers:	15
Bulk Api Vendors:	98
Clinical Trials:	57
Patent Applications:	3,483
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ADAPALENE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADAPALENE
DailyMed Link:	ADAPALENE at DailyMed

Pharmacology for ADAPALENE

Ingredient-type	Retinoids
Drug Class	Retinoid

Medical Subject Heading (MeSH) Categories for ADAPALENE

Anti-Inflammatory Agents, Non-Steroidal

Dermatologic Agents

Synonyms for ADAPALENE

(non-d)Adapalene-d15

106685-40-9

1L4806J2QF

2-Naphthalenecarboxylic acid, 6-(4-methoxy-3-tricyclo(3.3.1.1(sup 3,7))dec-1-ylphenyl)-

2-Naphthalenecarboxylic acid, 6-(4-methoxy-3-tricyclo[3.3.1.13,7]dec-1-ylphenyl)-

4CA-0111

6-(3-((3r,5r,7r)-adamantan-1-yl)-4-methoxyphenyl)-2-naphthoic acid

6-(3-(1-Adamantyl)-4-methoxyphenyl)-2-naphthoic acid

6-(3-(Adamantan-1-yl)-4-methoxyphenyl)-2-naphthoic acid

6-(3-Adamantan-1-yl-4-methoxy-phenyl)-naphthalene-2-carboxylic acid

6-(3-adamantan-1-yl-4-methoxyphenyl)naphthalene-2-carboxylic acid

6-(4-Methoxy-3-tricyclo[3.3.1.13,7]dec-1-ylphenyl)-2-naphthalenecarboxylic acid

6-[3-(1-adamantyl)-4-methoxy-phenyl]naphthalene-2-carboxylic acid

6-[3-(1-ADAMANTYL)-4-METHOXYPHENYL]-2-NAPHTHALENE CARBOXYLIC ACID

6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthalene-carboxylic acid

6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthalenecarboxylic acid

6-[3-(1-Adamantyl)-4-methoxyphenyl]-2-naphthoic acid

6-[3-(1-adamantyl)-4-methoxyphenyl]naphthalene-2-carboxylic acid

6-[3-(adamantan-1-yl)-4-methoxyphenyl]-2-naphthoic acid

6-[3-(adamantan-1-yl)-4-methoxyphenyl]naphthalene-2-carboxylic acid

6-[4-methoxy-3-(tricyclo[3.3.1.1~3,7~]dec-1-yl)phenyl]naphthalene-2-carboxylic acid

6-[4-methoxy-3-(tricyclo[3.3.1.13,7]dec-1-yl)phenyl]naphthalene-2-carboxylic acid

685A409

A801483

AB0013899

AB01274764_03

AB01274764_04

AB01274764-01

AB01274764-02

AB13763

AB2000023

ABP000590

AC-1974

AC1L1SOH

AC1Q5USH

Adaferin

Adaferin (TN)

Adapalen

Adapalene (JAN/USAN/INN)

Adapalene [USAN:BAN:INN]

Adapalene [USAN:INN:BAN]

Adapalene for peak identification, European Pharmacopoeia (EP) Reference Standard

Adapalene, >=98% (HPLC)

Adapalene, European Pharmacopoeia (EP) Reference Standard

Adapalene, pharmaceutical secondary standard; traceable to USP and PhEur

Adapalene, United States Pharmacopeia (USP) Reference Standard

Adapalene/

Adapaleno

Adapaleno [INN-Spanish]

Adapalenum

Adapalenum [INN-Latin]

AJ-45604

AK-72900

AKOS005145841

AKOS015895391

Ambap106685-40-9

AN-593

AOB6389

API0001385

BC205779

BCP9000231

BDBM50048280

BIDD:GT0264

BR-72900

BRD-K33127281-001-01-5

C28H28O3

CAS-106685-40-9

CCG-213060

CCG-221237

CD 271

CD-271

CD271

CHEBI:31174

CHEMBL1265

CHEMBL76401

CPD000466349

CS-1789

CTK8E8906

D01112

D0JC9N

DB00210

Differin

Differin (TN)

Differin Gel

Differin Gel 0.1%

Differin, Adapalene

Differin, Teva, Pimpal, Gallet, Adelene, Adeferin

Differine

DR002478

DSSTox_CID_26481

DSSTox_GSID_46481

DSSTox_RID_81652

DTXSID5046481

EBD19549

F2173-0588

FT-0631040

GTPL5429

HMS3264F15

HMS3654F11

HY-B0091

I06-0642

I810

KB-246947

KS-000002B5

KS-1196

LS-172017

LZCDAPDGXCYOEH-UHFFFAOYSA-N

MFCD03106112

MLS000759463

MLS006010036

MolPort-003-986-211

NAP030

NCGC00164617-01

NCGC00164617-02

NCGC00164617-04

NCGC00164617-05

PL029988

PL040836

RTR-001330

S-3513

s1276

SAM001246663

SC-17327

SCHEMBL2747

SMR000466349

SMR002529673

SR-01000942194

SR-01000942194-2

ST2412159

STL453114

TL8000241

Tox21_112236

Tox21_112236_1

TR-001330

UNII-1L4806J2QF

ZINC3784182

Tentative approvals for ADAPALENE

Applicant	Application No.	Strength	Dosage Form
		1%;2%	GEL;TOPICAL

US Patents and Regulatory Information for ADAPALENE

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	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes			Y
Perrigo Israel	ADAPALENE AND BENZOYL PEROXIDE	adapalene; benzoyl peroxide	GEL;TOPICAL	205033-001	Jan 23, 2018	AB	RX	No	No
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	AB	RX	Yes	Yes
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015		RX	Yes	Yes

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Expired US Patents for ADAPALENE

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

Non-Orange Book US Patents for ADAPALENE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,653,140	Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
8,729,127	Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
8,921,423	Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid
9,381,179	Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders

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International Patents for ADAPALENE

Country	Document Number	Estimated Expiration
South Korea	20040111394
Russian Federation	2377981
Japan	2009508843
Poland	216763

Supplementary Protection Certificates for ADAPALENE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB10/005	United Kingdom		PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
C0024	France		PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218