DEOXYCHOLIC ACID - Generic Drug Details

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

Deoxycholic acid is the generic ingredient in two branded drugs marketed by Wilshire Pharms Inc and Abbvie, and is included in two NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Deoxycholic acid has one hundred and forty-one patent family members in thirty-seven countries.

There are thirty-three drug master file entries for deoxycholic acid. One supplier is listed for this compound.

Summary for DEOXYCHOLIC ACID

International Patents:	141
US Patents:	15
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	20
Patent Applications:	6,163
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEOXYCHOLIC ACID
What excipients (inactive ingredients) are in DEOXYCHOLIC ACID?	DEOXYCHOLIC ACID excipients list
DailyMed Link:	DEOXYCHOLIC ACID at DailyMed

Recent Clinical Trials for DEOXYCHOLIC ACID

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

Sponsor	Phase
Massachusetts General Hospital	Phase 1
Johns Hopkins University	Phase 1
Juva Skin & Laser Center	Phase 4

See all DEOXYCHOLIC ACID clinical trials

Pharmacology for DEOXYCHOLIC ACID

Drug Class	Cytolytic Agent
Physiological Effect	Decreased Cell Membrane Integrity

Medical Subject Heading (MeSH) Categories for DEOXYCHOLIC ACID

Cholagogues and Choleretics

Anatomical Therapeutic Chemical (ATC) Classes for DEOXYCHOLIC ACID

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for DEOXYCHOLIC ACID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYBELLA	Injection	deoxycholic acid	10 mg/mL (2 mL)	206333	1	2018-07-13

US Patents and Regulatory Information for DEOXYCHOLIC ACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes			Y

International Patents for DEOXYCHOLIC ACID

Country	Patent Number	Title	Estimated Expiration
Portugal	2380576
Hong Kong	1101062	USE OF A DETERGENT FOR THE NON-SURGICAL REMOVAL OF FAT
Argentina	112325	MÉTODO DE PREPARACIÓN DEL ÁCIDO BILIAR SINTÉTICO
United Kingdom	2452358	Preparation of bile acids and intermediates thereof
South Korea	20150013305	SYNTHETIC BILE ACID COMPOSITION, METHOD, AND PREPARATION

Supplementary Protection Certificates for DEOXYCHOLIC ACID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2380576	SPC/GB20/050	United Kingdom		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
1758590	LUC00029	Luxembourg		PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
2380576	122020000056	Germany		PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: EWR IS/1/16/071/01 20160729
3692995	301229	Netherlands		PRODUCT NAME: DEOXYCHOLAAT; NATIONAL REGISTRATION NO/DATE: RVG120593 20170804; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
2380576	20C1048	France		PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729

DEOXYCHOLIC ACID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Deoxycholic Acid

Introduction

Deoxycholic acid, a synthetic form of a bile acid, has gained significant attention in recent years, particularly in the aesthetic medicine sector. Its primary application is in the reduction of submental fat, commonly known as a double chin, through the FDA-approved treatment ATX-101, also known as Kybella.

Market Size and Growth Potential

The market for fat dissolving injections, which includes deoxycholic acid, is substantial and growing. As of 2023, the fat dissolving injection market was valued at USD 3.5 billion and is projected to reach USD 5.6 billion by 2031, with a compound annual growth rate (CAGR) of 9.1% during the forecast period[3].

Market Drivers

Several factors are driving the growth of the deoxycholic acid market:

Increasing Demand for Aesthetic Treatments

The demand for non-invasive aesthetic treatments is on the rise, driven by consumer preferences for minimally invasive procedures that offer quick and effective results. Deoxycholic acid, with its FDA approval for submental fat reduction, is a key beneficiary of this trend[3].

Technological Advancements

Advancements in medical technology and the development of new formulations have improved the efficacy and safety of deoxycholic acid treatments. This has enhanced its appeal to both patients and healthcare providers[2].

Expanding Patient Base

The growing awareness of aesthetic treatments and the increasing willingness of individuals to invest in their appearance are expanding the patient base for deoxycholic acid treatments. This includes a broader demographic, not limited to younger populations, but also older individuals seeking to maintain a youthful appearance[3].

Market Restraints

Despite the growth potential, there are several restraints that could impact the market:

Regulatory Challenges

Stringent regulatory requirements and the need for extensive clinical trials can slow down the approval and market entry of new deoxycholic acid formulations. This can limit the pace of innovation and market expansion[5].

Side Effects and Safety Concerns

Deoxycholic acid treatments, while generally safe, can have side effects such as injection-site pain, erythema, and hematoma. These side effects, although mild and temporary, can deter some potential patients[2].

Competition from Alternative Treatments

The aesthetic medicine market is highly competitive, with various treatments available for fat reduction, including other injectable therapies and surgical options. This competition can affect the market share of deoxycholic acid treatments[3].

Financial Trajectory

The financial trajectory of deoxycholic acid is closely tied to the overall growth of the fat dissolving injection market.

Revenue Projections

The fat dissolving injection market, which includes deoxycholic acid, is expected to grow from USD 3.5 billion in 2023 to USD 5.6 billion by 2031. This growth is driven by increasing demand, technological advancements, and expanding patient bases[3].

Key Players and Market Share

Companies like Kythera Biopharmaceuticals, Inc., which developed ATX-101 (Kybella), play a significant role in the market. These companies invest heavily in research and development to improve treatment efficacy and safety, which in turn drives market growth and revenue[2].

Regional Analysis

The market for deoxycholic acid is geographically diverse, with different regions contributing to its growth:

North America

North America, particularly the United States and Canada, is a dominant market for deoxycholic acid treatments. This region benefits from a well-established healthcare infrastructure and high spending on aesthetic treatments[3].

Europe

Europe is another significant market, with countries like the UK, Germany, and France showing strong demand for aesthetic treatments. The regulatory environment in Europe is also supportive, facilitating the approval and marketing of new treatments[3].

Asia-Pacific

The Asia-Pacific region, including countries like China, Japan, and India, is emerging as a fast-growing market. Increasing healthcare expenditure and growing awareness of aesthetic treatments are driving the demand for deoxycholic acid in this region[3].

Product Type and Application

Deoxycholic acid is primarily categorized under the product type of fat dissolving injections:

Deoxycholic Acid

Deoxycholic acid is a synthetic form of a bile acid that selectively targets adipocytes for cell lysis. It is FDA-approved for the reduction of submental fat and is also used in other body contouring and facial contouring applications[2][3].

End Users

The primary end users of deoxycholic acid treatments include:

• Hospitals: Where more complex procedures may be performed.
• Aesthetic Clinics: Specialized clinics focusing on non-invasive aesthetic treatments.
• Dermatology Clinics: Clinics specializing in skin and related treatments.
• Medical Spas: Facilities offering a range of aesthetic and wellness treatments[3].

Clinical and Regulatory Aspects

The clinical and regulatory aspects of deoxycholic acid are crucial for its market success:

FDA Approval

Deoxycholic acid, under the brand name Kybella, was FDA-approved in 2015 for the reduction of submental fat. The approval was based on extensive clinical trials that demonstrated its safety and efficacy[5].

Clinical Trials

The clinical trials for deoxycholic acid involved multiple phases, including phase I, II, and III trials. These trials established the optimal dosing and treatment regimen and demonstrated the treatment's efficacy in reducing submental fat[5].

Key Takeaways

• Growing Market: The fat dissolving injection market, including deoxycholic acid, is expected to grow significantly, reaching USD 5.6 billion by 2031.
• Increasing Demand: The demand for non-invasive aesthetic treatments is driving the growth of deoxycholic acid treatments.
• Regulatory Environment: FDA approval and compliance with good clinical practices are critical for the market success of deoxycholic acid.
• Regional Growth: North America, Europe, and the Asia-Pacific region are key markets for deoxycholic acid treatments.
• Competitive Landscape: The market is competitive, with several players investing in research and development to improve treatment efficacy and safety.

FAQs

1. What is deoxycholic acid used for?

Deoxycholic acid is used primarily for the reduction of submental fat, commonly known as a double chin, through the FDA-approved treatment ATX-101 (Kybella).

2. How does deoxycholic acid work?

Deoxycholic acid works by selectively targeting adipocytes for cell lysis, breaking down and absorbing fat cells which the body then naturally eliminates.

3. What are the common side effects of deoxycholic acid treatments?

Common side effects include injection-site pain, erythema, and hematoma, which are generally mild and temporary.

4. Which regions are the largest markets for deoxycholic acid treatments?

North America, particularly the United States and Canada, and the Asia-Pacific region, including countries like China, Japan, and India, are the largest and fastest-growing markets.

5. What is the projected market size for fat dissolving injections by 2031?

The fat dissolving injection market, which includes deoxycholic acid, is projected to reach USD 5.6 billion by 2031.

Sources

1. Ursodeoxycholic Acid Market Size, Trends And Forecast To 2031 - Coherent Market Insights
2. Deoxycholic Acid for Submental Fat - Rejuvenation Resource
3. Fat Dissolving Injection Market Size, Share, Trends And Forecast - Verified Market Research
4. Ursodeoxycholic Acid Market Size – Trends Analysis Report, 2032 - Global Market Insights
5. 206333Orig1s000 - accessdata.fda.gov - FDA Documentation