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Last Updated: August 8, 2020

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CHOLBAM Drug Profile

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When do Cholbam patents expire, 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

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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
University of PittsburghPhase 1/Phase 2
Children's Hospital Medical Center, CincinnatiPhase 1/Phase 2
University of NebraskaPhase 1/Phase 2

See all CHOLBAM clinical trials

Pharmacology for CHOLBAM
Drug ClassBile Acid

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
>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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