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Azelaic acid - Generic Drug Details

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What are the generic sources for azelaic acid and what is the scope of azelaic acid freedom to operate?

Azelaic acid is the generic ingredient in three branded drugs marketed by Leo Pharma As, Aqua Pharms Llc, Actavis Labs Ut Inc, Glenmark Pharms, and Tolmar, and is included in six NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Azelaic acid has one hundred and ninety-five patent family members in thirty-one countries.

There are eight drug master file entries for azelaic acid. Nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for azelaic acid

International Patents:	195
US Patents:	9
Tradenames:	3
Applicants:	5
NDAs:	6
Drug Master File Entries:	8
Suppliers / Packagers:	9
Bulk Api Vendors:	98
Clinical Trials:	28
Patent Applications:	5,792
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for azelaic acid
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for azelaic acid
DailyMed Link:	azelaic acid at DailyMed

Pharmacology for azelaic acid

Physiological Effect

Decreased Protein Synthesis Decreased Sebaceous Gland Activity

Synonyms for azelaic acid

0C50D8EC-0DB0-4F24-8EFC-2919E1F0D9BF

1,7-Dicarboxyheptane

1,7-Heptanedicarboxylate

1,7-Heptanedicarboxylic acid

1,9-Nonanedioate

1,9-Nonanedioic acid

123-99-9

123-99-9 (Parent)

17265-13-3 (di-hydrochloride salt)

17356-30-8 (mono-hydrochloride salt)

19619-43-3 (unspecified potassium salt)

1tuf

21175-EP2269988A2

21175-EP2270008A1

21175-EP2275413A1

21175-EP2287156A1

21175-EP2292617A1

21175-EP2301940A1

21175-EP2314295A1

21175-EP2374895A1

21175-EP2380874A2

26776-28-3

27825-99-6

27825-99-6 (unspecified hydrochloride salt)

32733-99-6

38900-29-7 (di-lithium salt)

4-02-00-02055 (Beilstein Handbook Reference)

52457-54-2 (di-potassium salt)

A-9800

A0561

AB00052140_12

AC1L1DAO

AC1Q75FC

acide azelaique

Acide azelaique [French]

Acido azelaico

Acido azelaico [Spanish]

Acidum acelaicum

acidum azelaicum

Acidum azelaicum [Latin]

ACMC-1BTAP

AGN-191861

AI3-06299

AK174117

AKOS000120052

AN-22935

Anchoate

Anchoic acid

ANW-18182

ARONIS24596

AZ1

Azalaic Acid

Azelaic

Azelaic acid (USAN/INN)

Azelaic acid [USAN:INN]

Azelaic acid 99%

azelaic acid dipotassium salt

Azelaic acid polyanhydride

AZELAIC ACID, 95%

Azelaic acid, 98%

Azelaic acid, 98% 25g

Azelaic acid, analytical standard

Azelaic acid, technical grade

Azelaic acid, technical grade, 80%

Azelaic acid, technical, ~85% (GC)

Azelaic acid, Vetec(TM) reagent grade

Azelaic acid,technical grade

Azelaic polyanhydride

azelaicacid

Azelaicacidtech

Azelainic acid

Azelainsaeure

Azelainsaure

azelate

Azelex

Azelex (TN)

Azleaic Acid

BDJRBEYXGGNYIS-UHFFFAOYSA-N

BIDD:GT0315

BRN 1101094

BSPBio_001756

C08261

CAS-123-99-9

CCG-40081

CHEBI:48131

CHEMBL1238

CTK0H8917

D03034

D0E4WR

DB00548

Dicarboxylic acid C9

Dicarboxylic acid C9; Nonanedioic acid; AZA

DivK1c_000532

DSSTox_CID_1640

DSSTox_GSID_21640

DSSTox_RID_76254

DTXSID8021640

EINECS 204-669-1

Emerox 1110

Emerox 1144

Emery's L-110

Epitope ID:187039

EU-0100051

F2VW3D43YT

F8889-5093

Finacea

Finacea (TN)

Finevin

Finevin (TN)

FT-0626920

GTPL7484

heptane-1,7-dicarboxylic acid

Heptanedicarboxylic acid

HMS1921O11

HMS2092E22

HMS2234D10

HMS3260K03

HMS3372J07

HMS501K14

HSDB 7659

HY-B0704

I04-0585

IDI1_000532

InChI=1/C9H16O4/c10-8(11)6-4-2-1-3-5-7-9(12)13/h1-7H2,(H,10,11)(H,12,13

KB-74817

KBio1_000532

KBio2_000437

KBio2_003005

KBio2_005573

KBio3_001256

KBioGR_000662

KBioSS_000437

KS-00000WLV

KS-000046KE

KS-5293

KSC178S1P

Lepargylate

Lepargylic acid

LMFA01170054

Lopac-246379

Lopac0_000051

LP00051

LP083134

LS-22779

LS41867

M112324

MCULE-4093240509

MFCD00004432

MLS-0066619

MLS-0066619.P021

MLS000069659

MLS001148615

MolPort-001-779-873

n-Nonanedioate

n-Nonanedioic acid

NCGC00014993-01

NCGC00014993-02

NCGC00014993-03

NCGC00014993-04

NCGC00014993-05

NCGC00014993-06

NCGC00014993-07

NCGC00014993-08

NCGC00014993-09

NCGC00014993-10

NCGC00014993-12

NCGC00093565-01

NCGC00093565-02

NCGC00093565-03

NCGC00093565-04

NCGC00093565-05

NCGC00093565-06

NCGC00093565-07

NCGC00256508-01

NCGC00259538-01

NCGC00260736-01

NE10317

NINDS_000532

Nonandisaeure

Nonandisaure

NONANEDIOIC ACID

Nonanedioic acid Azelaic acid

Nonanedioic acid homopolymer

Nonanedioic acid, homopolymer

Nonanedioic acid, sodium salt

NSC 19493

NSC-19493

NSC-757406

NSC19493

NSC757406

Opera_ID_740

Pharmakon1600-01500648

Poly(azelaic anhydride)

Polyazelaic anhydride

Polyazelaic Polyanhydride

RP17465

RTR-003741

s4550

SBB060279

SBI-0050040.P003

SC-16119

SCHEMBL3887

SDCCGMLS-0066619.P001

SH-441

Skinorem

Skinoren

Skinoren (TN)

SMR000059164

SPBio_001089

Spectrum_000057

SPECTRUM1500648

Spectrum2_000995

Spectrum3_000278

Spectrum4_000401

Spectrum5_001304

SR-01000075671

SR-01000075671-1

ST45053319

STL059432

Tox21_110063

Tox21_110063_1

Tox21_201989

Tox21_303011

Tox21_500051

TR-003741

TRA0060478

UNII-F2VW3D43YT

Z57127532

ZINC1531036

ZK 62498

ZK-62498

Tentative approvals for AZELAIC ACID

Applicant	Application No.	Strength	Dosage Form
		15%	GEL;TOPICAL

US Patents and Regulatory Information for azelaic acid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Labs Ut Inc	AZELAIC ACID	azelaic acid	GEL;TOPICAL	208011-001	Nov 19, 2018	AB	RX	No	No
Tolmar	AZELAIC ACID	azelaic acid	GEL;TOPICAL	208724-001	Nov 19, 2018	AB	RX	No	No
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes			Y
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes			Y
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes			Y
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes			Y

Expired US Patents for azelaic acid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aqua Pharms Llc	AZELEX	azelaic acid	CREAM;TOPICAL	020428-001	Sep 13, 1995
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002

International Patents for azelaic acid

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007085899
Israel	136101
Denmark	2494959
World Intellectual Property Organization (WIPO)	2008110872
European Patent Office	1917072
World Intellectual Property Organization (WIPO)	2007007198
China	1856294