Cholic acid - Generic Drug Details

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

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	44
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	13
What excipients (inactive ingredients) are in cholic acid?	cholic acid excipients list
DailyMed Link:	cholic acid at DailyMed

Recent Clinical Trials for cholic acid

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

Sponsor	Phase
The Fifth Hospital of Wuhan	PHASE2
Hubei Hospital of Traditional Chinese Medicine	PHASE2
Xiangyang No.1 People's Hospital	PHASE2

See all cholic acid clinical trials

Pharmacology for cholic acid

Drug Class

Bile Acid

Anatomical Therapeutic Chemical (ATC) Classes for cholic acid

A05AA	Bile acids and derivatives
A05A	BILE THERAPY
A05	BILE AND LIVER THERAPY
A	Alimentary tract and metabolism

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

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/001250Orphacol 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/002081Cholic 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

Market Dynamics and Financial Trajectory for Cholalic Acid

Last updated: February 16, 2026

Cholalic acid is a naturally occurring bile acid involved in lipid digestion and absorption. Its applications in pharmaceuticals primarily target cholestatic liver diseases and certain metabolic conditions. The market for cholalic acid and related bile acids is influenced by several factors, including therapeutic demand, regulatory pathways, manufacturing complexities, and competitive landscape.

Market Size and Growth Drivers

The global market for bile acids, including cholalic acid, was valued at approximately USD 55 million in 2021. It is projected to reach near USD 80 million by 2028, growing at a compound annual growth rate (CAGR) around 6.0% from 2022 to 2028 (source: Reports and Market Research Databases).

Key drivers include:

• Rising prevalence of liver-related disorders such as cholestasis, primary biliary cirrhosis, and gallstone diseases.
• Increasing adoption of bile acid therapy for metabolic syndrome management.
• Expanding pipeline of formulations and derivatives with improved efficacy and safety profiles.
• Growing geriatric population susceptible to liver conditions.

Constraints:

• Limited patent protections for natural bile acids like cholalic acid, leading to generic competition.
• Strict regulatory pathways for approval, necessitating rigorous clinical trial data.
• Manufacturing challenges involving complex extraction, purification, and stability considerations.

Competitive Landscape and Supply Chain

Major players include:

• Global pharmaceutical companies with existing bile acid products or derivatives.
• Specialty manufacturers producing raw cholalic acid through extraction or synthesis.
• Biotech firms exploring synthetic or semi-synthetic derivatives with enhanced therapeutic properties.

Supply chain considerations are:

• Raw material sourcing from animal or microbial sources.
• Synthetic routes requiring advanced chemistry processes.
• Distribution channels primarily focused on hospital pharmacies, specialty clinics, and research institutions.

Regulatory Environment

Cholalic acid, classified as an active pharmaceutical ingredient (API), must navigate clinical efficacy validations, safety assessments, and quality standards set by agencies like the FDA, EMA, and other regulatory bodies.

Market entry strategies typically involve orphan drug designations for rare liver diseases, fast-track approvals based on promising clinical data, or inclusion in combination therapies.

Financial Trajectory

Investments are concentrated in research and development (R&D) to modify or improve natural cholalic acid's pharmacokinetics, stability, and dosing profiles.

R&D expenditure for bile acid derivatives can range from USD 10 million to USD 50 million annually, depending on the scope and stage of development.

Profitability depends on:

• Patent protection period—generics dominate once patents expire, reducing prices.
• Clinical trial success—successful Phase III trials can justify higher pricing models in orphan indications.
• Market penetration—targets like specialized liver conditions tend to have higher per-unit pricing.

Market Forecast and Investment Outlook

While the current market is niche, growth prospects are tied to emerging clinical applications and synthetic analogs. Expected incremental revenue opportunities will be highest in formulations that demonstrate superior efficacy, reduced side effects, or versatile delivery mechanisms.

Fostering partnerships with biotech firms or academic institutions accelerates innovation and market access. Entry into emerging markets, such as China or India, also expands revenue potential due to increasing healthcare spending and disease prevalence.

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Key Takeaways

• The mid-term outlook for cholalic acid emphasizes modest growth driven by demand for liver disease treatments and synthetic derivatives development.
• Market constraints include patent expiry, regulatory hurdles, and manufacturing complexities.
• The competitive landscape is fragmented, with opportunities for innovation via derivatives or combination therapies.
• R&D investments remain crucial for capturing higher-margin opportunities from new formulations or indications.
• Strategic partnerships and geographic expansion support revenue diversification and market share growth.

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FAQs

1. What therapeutic applications drive demand for cholalic acid?
Treatment of cholestatic liver diseases, metabolic syndrome, and gallstone dissolution are primary areas. Off-label exploration includes lipid metabolism disorders.

2. How does patent life affect market potential?
Patent expiry encourages generic manufacturing, decreasing prices and margins, but also opens opportunities for competitors producing derivatives.

3. Are synthetic or semi-synthetic derivatives more commercially viable?
Synthetic derivatives with enhanced properties and patent protections offer better margins, but require higher R&D investment and regulatory approval.

4. What regulatory challenges exist?
Demonstrating safety and efficacy in targeted indications is necessary; approvals often depend on clinical trial results and orphan drug designations.

5. Which regions present the most growth opportunity?
Developed markets like North America and Europe have established pathways, though emerging markets in Asia-Pacific show significant long-term growth potential due to rising liver disease prevalence.

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Sources:

[1] Market Research Future. "Global Bile Acid Market Analysis." 2022.
[2] Reports and Market Databases. "Pharmaceutical Bile Acid Segment Report," 2023.
[3] U.S. FDA. "Guidance for Industry: Bile Acid Products," 2021.