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Last Updated: December 14, 2019

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Deoxycholic acid - Generic Drug Details

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What are the generic drug sources for deoxycholic acid and what is the scope of patent protection?

Deoxycholic acid is the generic ingredient in one branded drug marketed by Kythera Biopharms and is included in one NDA. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Deoxycholic acid has one hundred and nineteen patent family members in thirty-four countries.

There are thirty-three drug master file entries for deoxycholic acid. One supplier is listed for this compound.

Recent Clinical Trials for deoxycholic acid

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

SponsorPhase
AllerganPhase 4
Juva Skin & Laser CenterPhase 4
University of California, San DiegoEarly Phase 1

See all deoxycholic acid clinical trials

Recent Litigation for deoxycholic acid

Identify potential future generic entrants

District Court Litigation
Case NameDate
KYTHERA BIOPHARMACEUTICALS, INC. v. SLAYBACK PHARMA LLC2018-11-09
Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd.2017-05-31

See all deoxycholic acid litigation

Pharmacology for deoxycholic acid
Medical Subject Heading (MeSH) Categories for deoxycholic acid
Synonyms for deoxycholic acid
(3ALPHA,5ALPHA,12ALPHA)-3,12-DIHYDROXYCHOLAN-24-OIC ACID
(3alpha,5alpha,8alpha,12alpha,14beta,17alpha)-3,12-dihydroxycholan-24-oic acid
(3alpha,5beta,12alpha)-3,12-Dihydroxycholan-24-oic acid
(4R)-4-((1S,2S,11S,16S,5R,7R,10R,14R,15R)-5,16-dihydroxy-2,15-dimethyltetracyc lo[8.7.0.0<2,7>.0<11,15>]heptadec-14-yl)pentanoic acid
(4R)-4-((3R,8R,9S,10S,12S,13R,14S,17R)-3,12-dihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid
(4R)-4-[(1S,2S,5R,7R,10R,11S,14R,15R,16S)-5,16-dihydroxy-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadecan-14-yl]pentanoic acid
(4R)-4-[(1S,2S,5R,7R,10R,11S,14R,15R,16S)-5,16-dihydroxy-2,15-dimethyltetracyclo[8.7.0.0(2),.0(1)(1),(1)]heptadecan-14-yl]pentanoic acid
(4R)-4-[(3R,5R,8R,9S,10S,12S,13R,14S,17R)-3,12-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid
(R)-4-((3R,5R,8R,9S,10S,12S,13R,14S,17R)-3,12-dihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid
005990WHZZ
115349-14-9
17-beta-(1-Methyl-3-carboxypropyl)-etiocholane-3-alpha,12-alpha-diol
17.beta.-(1-Methyl-3-carboxypropyl)-etiocholane-3.alpha.,12.alpha.-diol
1e3v
25793-EP2289879A1
25793-EP2295401A2
25793-EP2315303A1
3-.alpha.,12-.alpha.-Dihydroxycholansaeure
3-alpha,12-alpha-Dihydroxy-5-beta-cholan-24-oic acid
3-alpha,12-alpha-Dihydroxy-5-beta-cholanoic acid
3-alpha,12-alpha-Dihydroxycholansaeure
3-alpha,12-alpha-Dihydroxycholansaeure [German]
3-Hydroxy-polydeoxycholic acid
3,12-Dihydroxycholan-24-oic acid, (3.alpha.,5.beta.,12.alpha.)- #
3,12-Dihydroxycholan-24-oic acid, (3alpha,5beta,12alpha)-
3,12-Dihydroxycholanic acid
3.alpha.,12.alpha.-Dihydroxy-5.beta.-cholan-24-oic acid
3.alpha.,12.alpha.-Dihydroxy-5.beta.-cholanic acid
3.alpha.,12.alpha.-Dihydroxy-5.beta.-cholanoic acid
3.alpha.,12.alpha.-Dihydroxycholanic acid
3|A,12|A-Dihydroxy-5|A-cholanic acid
302-95-4 (mono-hydrochloride salt))
3alpha-Hydroxy-polydeoxycholate
3alpha,12alpha-Dihydroxy-5beta-cholan-24-oic acid
3alpha,12alpha-Dihydroxy-5beta-cholanate
3alpha,12alpha-Dihydroxy-5beta-cholanic acid
4-10-00-01608 (Beilstein Handbook Reference)
5-beta-Cholan-24-oic acid, 3-alpha,12-alpha-dihydroxy-
5-beta-Deoxycholic acid
5.beta.-Cholan-24-oic acid, 3.alpha.,12.alpha.-dihydroxy-
5.beta.-Cholan-24-oic acid,12.alpha.-dihydroxy-
5b-Cholanic acid-3a,12a-diol
5b-Deoxycholate
5b-Deoxycholic acid
5beta-Cholan-24-oic acid, 3alpha,12alpha-dihydroxy-
5beta-Cholan-24-oic acid, 3alpha,12alpha-dihydroxy- (8CI)
7-Deoxycholate
7-Deoxycholic acid
7-Desoxycholic acid
7.alpha.-Deoxycholic acid
71888-65-8 (magnesium (2:1) salt)
728917-93-9
7alpha-Deoxycholic acid
83-44-3
AC1L5BW0
AKOS005622617
AN-774
AS-13233
ATX 101
ATX-101
ATX101
BBL013877
BDBM50375599
BIDD:PXR0198
bmse000833
BP-13275
BRN 3219882
C04483
CCRIS 1627
CHEBI:28834
CHEMBL406393
Cholan-24-oic acid, 3,12-dihydroxy-, (3-.alpha., 5-.beta.,12-.alpha.)-
Cholan-24-oic acid, 3,12-dihydroxy-, (3-alpha,5-beta,12-alpha)-
Cholan-24-oic acid, 3,12-dihydroxy-, (3-alpha,5-beta,12-alpha)- (9CI)
Cholan-24-oic acid, 3,12-dihydroxy-, (3a,5b,12a)-
Cholan-24-oic acid, 3,12-dihydroxy-, (3alpha,5beta,12alpha)-
Cholan-24-oic acid, 3,12-dihydroxy-, (3alpha,5beta,12alpha)-, homopolymer
Cholan-24-oic acid,12-dihydroxy-, (3.alpha.,5.beta.,12.alpha.)-
Cholan-24-oic acid,3,12-dihydroxy-, (3a,5b,12a)-
Cholan-24-oic, 3,12-dihydroxy-(3alpha,5beta,12alpha)-
Choleic acid
Cholerebic
Cholic acid, deoxy-
Cholorebic
CS-7613
D10781
DB03619
de-oxycholate
Degalol
Deoxy cholic acid
deoxy-Cholate
deoxy-Cholic acid
Deoxycholatate
deoxycholate
Deoxycholatic acid
Deoxycholic Acid (Desoxycholic Acid), United States Pharmacopeia (USP) Reference Standard
Deoxycholic acid (USAN/INN)
Deoxycholic acid [USAN:INN]
DEOXYCHOLIC ACID FREE ACID
Deoxycholic acid, >=98% (HPLC)
Deoxycholic acid, >=99.0% (T)
Deoxycholic acid, 500 mug/mL in methanol, certified reference material
Deoxycholic acid, 98.5%
Deoxycholic acid, BioXtra, >=98% (HPLC)
Desoxycholic acid
Desoxycholic acid [NF]
Desoxycholsaeure
Desoxycholsaeure [German]
Desoxycholsaure
Dihydroxycholanoic acid
Droxolan
DTXSID0042662
DXC
EINECS 201-478-5
GTPL610
H681
HMS2270H22
HSDB 293
HY-N0593
KXGVEGMKQFWNSR-LLQZFEROSA-N
Kybella
Kybella (TN)
l7-.beta.-(1-Methyl-3-carboxypropyl)-etiocholane-3-.alpha.,12-.alpha.-diol
l7-beta-(1-Methyl-3-carboxypropyl)-etiocholane-3-alpha,12-alpha-diol
LMST04010040
MCULE-2553099876
MFCD00003673
MLS001066423
MLS001306460
MolPort-002-507-414
NCI60_041946
NSC 8797
NSC-8797
NSC8797
Pyrochol
s4689
SBB058040
SC-18172
SCHEMBL4300
Septochol
SMR000112166
Spectrum5_002007
SR-01000765601
SR-01000765601-2
STK801948
UNII-005990WHZZ
UNII-JIY1ILR284 component KXGVEGMKQFWNSR-LLQZFEROSA-N
W-3065
Z1945707492
ZINC3914810
Paragraph IV (Patent) Challenges for DEOXYCHOLIC ACID
Tradename Dosage Ingredient NDA Submissiondate
KYBELLA SOLUTION;SUBCUTANEOUS deoxycholic acid 206333 2018-07-13

US Patents and Regulatory Information for deoxycholic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kythera Biopharms KYBELLA deoxycholic acid SOLUTION;SUBCUTANEOUS 206333-001 Apr 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

Supplementary Protection Certificates for deoxycholic acid

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1758590 CA 2017 00067 Denmark   Start Trial PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 20170703; FIRST REG. NO/DATE: IS IS/1/16/071/01 20160729
1758590 LUC00029 Luxembourg   Start Trial PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
1758590 2017C/063 Belgium   Start Trial PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
1758590 122018000065 Germany   Start Trial PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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