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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.

Summary for CHOLBAM

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	71
Clinical Trials:	1
Patent Applications:	4,435
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CHOLBAM
DailyMed Link:	CHOLBAM at DailyMed

Generic Entry Opportunity Date for CHOLBAM

Constraining patent/regulatory exclusivity:

TREATMENT OF BILE ACID SYNTHESIS DISORDERS DUE TO SINGLE ENZYME DEFECTS

NDA:

205750

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.

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
Rtrx	CHOLBAM	cholic acid	CAPSULE;ORAL	205750-002	Mar 17, 2015		RX	Yes	Yes
Rtrx	CHOLBAM	cholic acid	CAPSULE;ORAL	205750-001	Mar 17, 2015		RX	Yes	No
Rtrx	CHOLBAM	cholic acid	CAPSULE;ORAL	205750-002	Mar 17, 2015		RX	Yes	Yes