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Last Updated: December 5, 2019

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FINACEA Drug Profile

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When do Finacea patents expire, and what generic alternatives are available?

Finacea is a drug marketed by Leo Pharma As and is included in two NDAs. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and sixty-two patent family members in twenty-one countries.

The generic ingredient in FINACEA is azelaic acid. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the azelaic acid profile page.

Drug patent expirations by year for FINACEA
Drug Prices for FINACEA

See drug prices for FINACEA

Drug Sales Revenue Trends for FINACEA

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Recent Clinical Trials for FINACEA

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

SponsorPhase
Clinical Research Center of the CarolinasPhase 4
Taro Pharmaceuticals USAPhase 1
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering PharmaPhase 4

See all FINACEA clinical trials

Recent Litigation for FINACEA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Bayer HealthCare Pharmaceuticals Inc. v. Perrigo UK FINCO Limited Partnership2018-02-15
LEO Pharma A/S v. Teva Pharmaceuticals USA, Inc.2018-01-03
Delcor Asset Corporation v. Taro Pharmaceutical Industries, Ltd.2016-03-01

See all FINACEA litigation

Pharmacology for FINACEA
Synonyms for FINACEA
0C50D8EC-0DB0-4F24-8EFC-2919E1F0D9BF
1,7-Dicarboxyheptane
1,7-Heptanedicarboxylate
1,7-Heptanedicarboxylic acid
1,9-Nonanedioate
1,9-Nonanedioic acid
1219811-33-2
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
AKOS000120052
AN-22935
Anchoate
Anchoic acid
ANW-18182
ARONIS24596
AZ1
Azalaic Acid
azelaate
Azelaic
azelaic acid
Azelaic acid (USAN/INN)
Azelaic acid [USAN:INN]
Azelaic acid 99%
Azelaic acid polyanhydride
AZELAIC ACID, 95%
Azelaic acid, 98%
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 polyanhydride
azelaicacid
Azelaicacidtech
Azelainic acid
Azelainsaeure
Azelainsaure
azelate
Azelex
Azelex (TN)
Azleaic Acid
BCP18690
BDJRBEYXGGNYIS-UHFFFAOYSA-N
BIDD:GT0315
BRN 1101094
BSPBio_001756
C08261
CAS-123-99-9
CCG-40081
CHEBI:48131
CHEMBL1238
CTK0H8917
D03034
DB00548
Dicarboxylic acid C9; Nonanedioic acid; AZA
DivK1c_000532
DSSTox_CID_1640
DSSTox_GSID_21640
DSSTox_RID_76254
DTXSID8021640
EC 204-669-1
EINECS 204-669-1
Emerox 1110
Emerox 1144
Emery's L-110
Epitope ID:187039
EU-0100051
F2VW3D43YT
F8889-5093
Finacea (TN)
Finevin
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
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
nonanedionic acid
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
SMR000059164
SPBio_001089
Spectrum_000057
SPECTRUM1500648
Spectrum2_000995
Spectrum3_000278
Spectrum4_000401
Spectrum5_001304
SR-01000075671
SR-01000075671-1
SR-01000075671-4
SR-01000075671-6
ST45053319
STL059432
Tox21_110063
Tox21_110063_1
Tox21_201989
Tox21_303011
Tox21_500051
TR-003741
TRA0060478
UNII-F2VW3D43YT
Z57127532
ZINC1531036
ZK 62498
ZK-62498
Paragraph IV (Patent) Challenges for FINACEA
Tradename Dosage Ingredient NDA Submissiondate
FINACEA AEROSOL, FOAM;TOPICAL azelaic acid 207071 2017-09-14
FINACEA GEL;TOPICAL azelaic acid 021470 2012-07-27

US Patents and Regulatory Information for FINACEA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 FINACEA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002   Start Trial   Start Trial
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015   Start Trial   Start Trial
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
McKesson
Dow
Moodys
Medtronic

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