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Last Updated: November 13, 2019

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CHOLBAM Drug Profile

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Which patents cover Cholbam, and when can generic versions of Cholbam launch?

Cholbam is a drug marketed by Rtrx and is included in one NDA.

The generic ingredient in CHOLBAM is cholic acid. There are forty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cholic acid profile page.

Drug patent expirations by year for CHOLBAM
Drug Prices for CHOLBAM

See drug prices for CHOLBAM

Generic Entry Opportunity Date for CHOLBAM
Generic Entry Date for CHOLBAM*:
Constraining patent/regulatory exclusivity:
TREATMENT OF BILE ACID SYNTHESIS DISORDERS DUE TO SINGLE ENZYME DEFECTS
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CHOLBAM

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

SponsorPhase
Children's Hospital Medical Center, CincinnatiPhase 1/Phase 2
University of NebraskaPhase 1/Phase 2
University of Colorado, DenverPhase 1/Phase 2

See all CHOLBAM clinical trials

Pharmacology for CHOLBAM
Drug ClassBile Acid
Synonyms for CHOLBAM
(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 (TN)
cholic acid
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 CHOLBAM

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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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
Johnson and Johnson
Boehringer Ingelheim
Harvard Business School
Merck

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