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Last Updated: December 8, 2019

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Cholic acid - Generic Drug Details

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

Cholic acid is the generic ingredient in one branded drug marketed by Rtrx and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are forty-four drug master file entries for cholic acid. One supplier is listed for this compound.

Recent Clinical Trials for cholic acid

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

SponsorPhase
Pierre and Marie Curie UniversityPhase 4
Lars Kristian MunckPhase 4
University of PittsburghPhase 1/Phase 2

See all cholic acid clinical trials

Pharmacology for cholic acid
Drug ClassBile Acid
Synonyms for cholic acid
(3.alpha.,5.beta.,7.alpha.,12.alpha.)-3,7,12-Trihydroxycholan-24-oic acid sodium salt
(3alpha,5beta,7alpha,12alpha)-3,7,12-trihydroxycholan-24-oic acid
(3alpha,5beta,7alpha,8alpha,12alpha,14beta,17alpha)-3,7,12-trihydroxycholan-24-oic acid
(3alpha,5beta,7alpha,8x,12alpha)-3,7,12-trihydroxycholan-24-oic acid
(3alpha,5beta,7alpha,8xi,12alpha)-3,7,12-trihydroxycholan-24-oic acid
(4R)-4-((3R,7R,8R,9S,10S,12S,13R,14S,17R)-3,7,12-trihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid
(4R)-4-[(1S,2S,5R,7S,9R,10R,11S,14R,15R,16S)-5,9,16-trihydroxy-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadecan-14-yl]pentanoic acid
(4R)-4-[(3R,5S,7R,8R,9S,10S,12S,13R,14S,17R)-3,7,12-trihydroxy-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,5S,7R,8R,10S,12S,13R,14S,17R)-3,7,12-trihydroxy-10,13-dimethyl-hexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid
(R)-4-((3R,5S,7R,8R,9S,10S,12S,13R,14S,17R)-3,7,12-Trihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid
10321-98-9
116-68-7
134353-30-3
17-beta-(1-Methyl-3-carboxypropyl)etiocholane-3alpha,7alpha,12alpha-triol
17.beta.-(1-Methyl-3-carboxypropyl)etiocholane-3.alpha.,7.alpha.,12.alpha.-triol
17b-[1-Methyl-3-carboxypropyl]etiocholane-3a,7a,12a-triol
17beta-[1-Methyl-3-carboxypropyl]etiocholane-3alpha,7alpha,12alpha-triol
198976-EP2280282A1
3-.alpha.,7-.alpha.,12-.alpha.-Trihydroxy-5-.beta.-cholan-24-oic acid
3-.alpha.,7-.alpha.,12-.alpha.-Trihydroxycholansaeure
3-&alpha,7-&alpha,12-&alpha-trihydroxy-5-&beta-cholanate
3-alpha,7-alpha,12-alpha-Trihydroxy-5-beta-cholan-24-oic acid
3-alpha,7-alpha,12-alpha-Trihydroxycholansaeure
3-alpha,7-alpha,12-alpha-Trihydroxycholansaeure [German]
3,7,12-trihydroxy-(3alpha,5alpha,7alpha,12alpha)-cholan-24-oate
3,7,12-trihydroxy-(3alpha,5alpha,7alpha,12alpha)-cholan-24-oic acid
3,7,12-Trihydroxy-cholan-24-oic acid (3-alpha,5-beta,7-alpha,12-alpha)
3,7,12-Trihydroxy-cholan-24-oic acid, (3.alpha.,5.beta.,7.alpha.,12.alpha.)-
3,7,12-Trihydroxycholan-24-oic acid, (3alpha,5beta,7alpha,12alpha)-
3,7,12-Trihydroxycholanic acid
3.alpha.,12.alpha.-Trihydroxy-5.beta.-cholanic acid
3.alpha.,7.alpha.,12.alpha.-Trihydroxy-5.beta.-cholanic acid
3|A,7|A,12|A-Trihydroxy-5|A-cholanic acid; Cholanic acid
3a,7a,12a-trihydroxy-(5a)-cholan-24-oate
3a,7a,12a-trihydroxy-(5a)-cholan-24-oic acid
3a,7a,12a-trihydroxy-5a-cholan-24-oate
3a,7a,12a-trihydroxy-5a-cholan-24-oic acid
3a,7a,12a-Trihydroxy-5A-cholanic acid
3a,7a,12a-Trihydroxy-5b-cholan-24-oate
3a,7a,12a-Trihydroxy-5b-cholan-24-oic acid
3a,7a,12a-Trihydroxy-5b-cholanate
3a,7a,12a-Trihydroxy-5b-cholanic acid
3a,7a,12a-Trihydroxy-5b-cholanoate
3a,7a,12a-Trihydroxy-5b-cholanoic acid
3a,7a,12a-Trihydroxy-b-cholanate
3a,7a,12a-Trihydroxy-b-cholanic acid
3a,7a,12a-Trihydroxy-beta-cholanate
3a,7a,12a-Trihydroxy-beta-cholanic acid
3a,7a,12a-Trihydroxycholanate
3a,7a,12a-Trihydroxycholanic acid
3alpha, 7alpha, 12alpha-trihydroxy-5beta-cholanic acid
3alpha, 7alpha, 12alpha-trihydroxy-5beta-cholanoic acid
3alpha,7alpha,12alpha-Trihydroxy-5 beta-cholan-24-ic acid
3alpha,7alpha,12alpha-Trihydroxy-5beta-cholan-24-oic acid
3alpha,7alpha,12alpha-Trihydroxy-5beta-cholanate
3alpha,7alpha,12alpha-Trihydroxy-5beta-cholanic acid
3alpha,7alpha,12alpha-Trihydroxy-5beta-cholanoic acid
3alpha,7alpha,12alpha-Trihydroxy-beta-cholanic acid
3alpha,7alpha,12alpha-Trihydroxycholanic acid
4-((1S,2S,7S,11S,16S,5R,9R,10R,14R,15R)-5,9,16-trihydroxy-2,15-dimethyltetracy clo[8.7.0.0<2,7>.0<11,15>]heptadec-14-yl)pentanoic acid
4-10-00-02072 (Beilstein Handbook Reference)
5.beta.-Cholan-24-oic acid, 3.alpha.,7.alpha.,12.alpha.-trihydroxy-
5.beta.-Cholan-24-oic acid,7.alpha.,12.alpha.-trihydroxy-
5.beta.-Cholic acid
5a-Allocholate
5a-Allocholic acid
5a-Cholate
5a-cholic acid
5b-Cholanic acid-3a,7a,12a-triol
5b-Cholate
5b-Cholic acid
5beta-Cholan-24-oic acid, 3alpha,7alpha,12alpha-trihydroxy-
5beta-Cholanic acid-3alpha,7alpha,12alpha-triol
5beta-Cholanic acid-3alpha,7alpha,12alpha-triol 5beta-Cholic acid
5beta-Cholanic acid, 3alpha,7alpha,12alpha-trihydroxy- (7CI)
7060-EP2289879A1
7060-EP2289883A1
7060-EP2315303A1
728917-96-2
732303-80-9
81-25-4
882740-42-3
889875-66-5
904791-60-2
AB1003389
AC1L5ACI
AK-77688
AKOS005622502
BBL029799
BDBM21680
BHQCQFFYRZLCQQ-OELDTZBJSA-N
BIC0608
BIDD:PXR0196
bmse000650
BP-30084
BRN 2822009
C00695
C24H40O5
CCRIS 1626
CHD
CHEBI:16359
CHEMBL205596
Cholalate
Cholalic acid
Cholalin
Cholan-24-oic acid, 3,7,12-trihydroxy-, (3-alpha,5-beta,7-alpha,12-alpha)-
Cholan-24-oic acid, 3,7,12-trihydroxy-, (3-alpha,5-beta,7-alpha,12-alpha)- (9CI)
Cholan-24-oic acid, 3,7,12-trihydroxy-, (3a,5b,7a,12a)-
Cholan-24-oic acid, 3,7,12-trihydroxy-, (3alpha,5beta,7alpha,12alpha)-
Cholan-24-oic acid, 3,7,12-trihydroxy-, (3alpha,5beta,7alpha,12alpha)- (9CI)
Cholan-24-oic acid,7,12-trihydroxy-, (3.alpha.,5.beta.,7.alpha.,12.alpha.)-
cholate
Cholbam
Cholbam (TN)
Cholic acid (8CI)
Cholic acid (USAN)
Cholic acid [USAN]
Cholic acid, 500 mug/mL in methanol, certified reference material
Cholic acid, 5beta-
Cholic acid, British Pharmacopoeia (BP) Reference Standard
Cholic acid, European Pharmacopoeia (EP) Reference Standard
Cholic acid, from ox or sheep bile, >=98%
Cholic acid, United States Pharmacopeia (USP) Reference Standard
Cholic acid, Vetec(TM) reagent grade, 98%
cholicacid
Cholsaeure
Cholsaeure [German]
Colalin
Colalin (VAN)
CS-6608
D10699
DB02659
DTXSID6040660
EC 201-337-8
EINECS 201-337-8
G1JO7801AE
GTPL609
HMS2268L18
HSDB 982
HY-N0324
K446
kolbam
LMST04010001
MCULE-7032345049
MFCD00003672
MLS001066422
MLS002207051
MolPort-003-892-613
N1680
NSC-6135
NSC6135
OrphacolReg
PubChem16772
SC-46787
SCHEMBL27461
SMR000112165
Spectrum5_002005
SR-01000765698
SR-01000765698-4
ST024722
ST24026431
STK801993
UNII-G1JO7801AE
UNII-JIY1ILR284 component BHQCQFFYRZLCQQ-OELDTZBJSA-N
ZINC6858022

US Patents and Regulatory Information for cholic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rtrx CHOLBAM cholic acid CAPSULE;ORAL 205750-001 Mar 17, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Rtrx CHOLBAM cholic acid CAPSULE;ORAL 205750-002 Mar 17, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Rtrx CHOLBAM cholic acid CAPSULE;ORAL 205750-001 Mar 17, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Rtrx CHOLBAM cholic acid CAPSULE;ORAL 205750-002 Mar 17, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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