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Last Updated: March 28, 2024

Cholic acid - Generic Drug Details


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What are the generic drug sources for cholic acid and what is the scope of freedom to operate?

Cholic acid is the generic ingredient in one branded drug marketed by Mirum 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.

Summary for cholic acid
Recent Clinical Trials for cholic acid

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

SponsorPhase
Vanderbilt UniversityPhase 3
Canadian Dermatology FoundationPhase 3
Vanderbilt University Medical CenterPhase 3

See all cholic acid clinical trials

Pharmacology for cholic acid
Drug ClassBile Acid

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

EU/EMA Drug Approvals for cholic acid

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Theravia Orphacol cholic acid EMEA/H/C/001250
Orphacol is indicated for the treatment of inborn errors in primary bile-acid synthesis due to 3β-hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3-oxosteroid-5β-reductase deficiency in infants, children and adolescents aged one month to 18 years and adults.
Authorised no no no 2013-09-12 2012-05-25
Retrophin Europe Ltd Kolbam cholic acid EMEA/H/C/002081
Cholic Acid FGK is indicated for the treatment of inborn errors of primary bile acid synthesis, in infants from one month of age for continuous lifelong treatment through adulthood, encompassing the following single enzyme defects:sterol 27-hydroxylase (presenting as cerebrotendinous xanthomatosis, CTX) deficiency;2- (or alpha-) methylacyl-CoA racemase (AMACR) deficiency;cholesterol 7 alpha-hydroxylase (CYP7A1) deficiency.
Withdrawn no no no 2015-11-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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