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CHOLBAM Drug Profile
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.
Summary for CHOLBAM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 74 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,492 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for CHOLBAM |
| DailyMed Link: | CHOLBAM at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Children's Hospital Medical Center, Cincinnati | Phase 1/Phase 2 |
| University of Nebraska | Phase 1/Phase 2 |
| University of Colorado, Denver | Phase 1/Phase 2 |
Pharmacology for CHOLBAM
| Drug Class | Bile 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 |
