CHOLIC ACID - Generic Drug Details

What are the generic drug sources for cholic acid and what is the scope of patent protection?

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:	10
Patent Applications:	6,608
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
Vanderbilt University	Phase 3
Canadian Dermatology Foundation	Phase 3
Vanderbilt University Medical Center	Phase 3

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

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

CHOLIC ACID Market Analysis and Financial Projection Experimental

Cholic Acid Market Dynamics and Financial Trajectory

Market Overview

Cholic acid, a primary bile acid synthesized from cholesterol in the liver, is a crucial component in the treatment of various liver and gallbladder disorders. The global cholic acid market is experiencing significant growth driven by several key factors.

Market Drivers

Increasing Prevalence of Gallstones and Liver Diseases

The rising number of gallstone cases worldwide, attributed to factors such as obesity, genetic disorders, and other medical conditions, is a primary driver for the market growth. This trend is particularly evident in regions like Asia Pacific, where the increasing obese population in countries like India and China is contributing to higher rates of gallstones and gallbladder cancer[3].

Pharmaceutical Industry Demand

Cholic acid is a key ingredient in the synthesis of pharmaceuticals, especially in the production of bile acid-based drugs used to treat liver and gallbladder disorders, such as primary biliary cirrhosis and bile acid synthesis disorders. The increasing demand from the pharmaceutical industry, coupled with innovations in diagnostic technologies and therapeutic applications, is driving market growth[3].

Geriatric Population and Metabolic Disorders

The growing geriatric population is associated with an increase in cases of cholesterol, kidney diseases, and other bile acid-related diseases. This demographic shift, along with the expansion of therapeutic applications of cholic acid, is further boosting market demand[1][2].

Market Restraints

Acute Liver Injury

One of the significant restraints on the market is the potential for acute liver injury due to the overdose of cholic acid and its medicines. This adverse effect can lead to jaundice and other liver-related complications, which may hinder market growth[1].

Market Segmentation

By Method

The cholic acid market is segmented based on methods such as folding ethanol crystallization, folding ethyl acetate separation, folding animal extraction, and others. The folding ethanol crystallization method is expected to experience significant growth in the near future[4].

By Application

The market is also segmented by application into organic acid, emulsifiers, detergents, medicines, and others. The organic acid segment is expected to expand at a significant CAGR throughout the forecast period[4].

Geographical Analysis

Europe

Europe is the largest market for cholic acid in terms of value and volume, primarily due to the high production of cholic acid and the presence of a large number of manufacturers in the region[1].

North America

North America is expected to be the fastest-growing market, driven by high R&D activities in the medical and pharmaceutical sectors. Key players such as Avanti Polar Lipids and Cayman Chemical are contributing to the regional growth[2].

Asia Pacific

The Asia Pacific region is expected to exhibit substantial growth due to the increasing number of kidney failure, gallstones, and other kidney-related disease cases. Countries like India and China are driving this growth due to their large and increasingly obese populations[1][3].

Latin America and Middle East & Africa

These regions are expected to show considerable growth by the end of the forecast period, primarily driven by the increasing geriatric population[1].

Financial Trajectory

Market Size and Growth Rate

The global cholic acid market was valued at USD 198.22 million in 2023 and is expected to reach USD 229.31 million by 2030, growing at a CAGR of 7.5% during the forecast period[2].

Revenue and Forecast

The market is projected to grow significantly, with some reports indicating a potential market size of USD 265 million by 2032, at a CAGR of 7.4%[3].

Key Players and Their Strategies

Major Players

Key players in the market include Dr Falk Pharma, Bruschettini, Zhongshan Belling Biotechnology, Shandong Green Bio-Pharmaceutical, and others. These companies are focusing on expanding their product portfolios and investing in research and development to enhance formulations and explore new indications[1][4].

Strategic Acquisitions and Pipeline Developments

Companies like Mirum Pharmaceuticals are actively involved in strategic acquisitions and pipeline developments. For instance, Mirum Pharmaceuticals completed the acquisition of CHENODAL® and CHOLBAM® and has several late-stage data catalysts in its pipeline, including studies for LIVMARLI and volixibat[5].

Regulatory and Economic Implications

Regulatory Environment

The market is influenced by regulatory changes, including those related to environmental and safety regulations. Compliance with these regulations is crucial for market growth[4].

Economic Factors

Economic factors such as healthcare expenditure, pharmaceutical R&D investment, and consumer purchasing power significantly impact the market dynamics. Economic growth and increased investment in healthcare can stimulate market expansion, while economic downturns may reduce demand for cholic acid[3].

Technological Advancements

Innovations in Diagnostic Technologies

Innovations in diagnostic technologies and the expansion of therapeutic applications of cholic acid are driving market growth. The focus on personalized medicine and targeted therapies is also contributing to the increasing demand for cholic acid[2].

Consumer Preferences

Demand for Natural and Organic Ingredients

Changing consumer preferences for natural and organic ingredients in cosmetics are driving the demand for cholic acid-based skincare products, further influencing market dynamics[3].

Key Takeaways

• The global cholic acid market is driven by the increasing prevalence of gallstones and liver diseases, demand from the pharmaceutical industry, and the growing geriatric population.
• Europe is the largest market for cholic acid, while North America is expected to be the fastest-growing region.
• The market faces restraints such as the potential for acute liver injury due to overdose.
• Key players are focusing on strategic acquisitions, R&D, and expanding their product portfolios.
• Economic and regulatory factors significantly influence market dynamics.

Frequently Asked Questions

1. What are the primary drivers of the cholic acid market?

The primary drivers include the increasing prevalence of gallstones and liver diseases, demand from the pharmaceutical industry, and the growing geriatric population.

2. Which region dominates the cholic acid market?

Europe dominates the cholic acid market in terms of value and volume due to high production and a large number of manufacturers.

3. What are the potential restraints on the cholic acid market?

The potential for acute liver injury due to overdose is a significant restraint on the market.

4. How is the market segmented?

The market is segmented by method (e.g., folding ethanol crystallization) and application (e.g., organic acid, emulsifiers, medicines).

5. What is the expected CAGR of the cholic acid market?

The market is expected to grow at a CAGR of 7.5% during the forecast period.

Cited Sources:

1. Fortune Business Insights - Cholic Acid Market Size, Industry Share, Forecast 2032
2. Stellar Market Research - Cholic Acid Market: Industry Analysis and Forecast
3. Market Research Future - Cholic Acid Market Analysis
4. Cognitive Market Research - Global Cholic Acid Market Report 2024 Edition
5. Business Wire - Mirum Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Update