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 sixteen 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-seven patent family members in thirty-eight 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:	147
US Patents:	16
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	22
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
Chang Gung Memorial Hospital	NA
Peking Union Medical College Hospital	PHASE1
First Affiliated Hospital Xi'an Jiaotong University	PHASE1

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
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
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

Expired US Patents for DEOXYCHOLIC ACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015

International Patents for DEOXYCHOLIC ACID

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2069383	COMPOSITION, PROCÉDÉ ET PRÉPARATION D'ACIDE BILIAIRE SYNTHÉTIQUE (SYNTHETIC BILE ACID COMPOSITION, METHOD, AND PREPARATION)
World Intellectual Property Organization (WIPO)	2008157635
Austria	E518565
Austria	E521355
World Intellectual Property Organization (WIPO)	2012112940
San Marino	P201000003	Composizione, metodo e preparazione di acidi biliari sintetici.
France	20C1048

Supplementary Protection Certificates for DEOXYCHOLIC ACID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2380576	122020000056	Germany		PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: EWR IS/1/16/071/01 20160729
2380576	41/2020	Austria		PRODUCT NAME: DESOXYCHOLSAEURE-NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 137169 20160825; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
1758590	132017000066197	Italy		PRODUCT NAME: SALE SODICO DI ACIDO DESOSSICOLICO(BELKYRA); AUTHORISATION NUMBER(S) AND DATE(S): 044896013, 20161219;IS/1/16/071/01, 20160729
1758590	122018000065	Germany		PRODUCT NAME: DEOXYCHOLSAEURE NATRIUMSALZ; NAT. REGISTRATION NO/DATE: 98586.00.00 20180104; FIRST REGISTRATION: IS IS/1/16/071/01 20160729
2380576	SPC/GB20/050	United Kingdom		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
1758590	2017C/063	Belgium		PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
1758590	300907	Netherlands		PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT; REGISTRATION NO/DATE: RVG120593 20170804

Market Dynamics and Financial Trajectory for Deoxycholic Acid

Last updated: July 29, 2025

Introduction

Deoxycholic acid (DCA), a bile acid naturally produced in humans, has evolved from a biological metabolite to a significant therapeutic agent, particularly in aesthetic medicine. Its primary medical application involves non-invasive fat reduction, notably through brands like Kybella (belonging to Allergan, now part of AbbVie). The shifting landscape of the global aesthetic and medical markets, regulatory developments, and advancing formulations significantly influence DCA's market dynamics and financial prospects.

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Market Overview

Deoxycholic acid’s segment focuses predominantly on minimally invasive fat destruction for localized adiposity. Its approval for submental fat reduction by the U.S. Food and Drug Administration (FDA) in 2015 marked a pivotal moment, establishing DCA as an alternative to surgical procedures such as liposuction. Globally, growing demand for body contouring treatments drives the expansion of DCA's market share.

In 2022, the global fat reduction market was valued at approximately USD 4.8 billion, with a compound annual growth rate (CAGR) projected around 10% through 2030, reflecting heightened consumer interest in non-invasive aesthetic procedures. DCA’s role, primarily via branded formulations like Kybella, is central to this expansion.

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Market Drivers

1. Rising Aesthetic Procedure Adoption
Aesthetic procedures have seen an unprecedented surge, fueled by increasing societal acceptance, social media influence, and broader demographic engagement. The American Society of Plastic Surgeons reports a 120% increase in minimally invasive fat reduction treatments from 2010 to 2020. DCA benefits from this trend by offering a safe, outpatient alternative with minimal downtime.

2. Aging Population and Body Image Consciousness
Globally, aging demographics and heightened body image awareness propel demand. Millennials and Generation Z seeking non-surgical, quick results bolster DCA's market footprint.

3. Regulatory Approvals and Expanding Indications
Post-FDA approval, other regulatory agencies globally have sanctioned DCA’s use. Countries like Canada, Australia, and across Europe have authorized DCA for submental fat reduction, expanding geographical access. Ongoing research into additional indications (e.g., other localized fat deposits) could further diversify application and bolster revenues.

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Market Challenges

1. Competitive Environment
DCA competes against other fat reduction modalities: cryolipolysis (CoolSculpting), laser lipolysis, and liposuction. While DCA's advantage lies in its minimally invasive profile and targeted action, product recognition depends heavily on branding and physician familiarity.

2. Regulatory and Safety Concerns
Though FDA-approved, DCA's adverse effects—such as edema, numbness, and nerve injury—necessitate precise application, which can limit adoption. Regulatory scrutiny remains critical, especially as new formulations and indications emerge.

3. Pricing Dynamics
High cost per session and multiple treatments are barriers. Insurance coverage is limited, emphasizing the importance of direct-to-consumer marketing and price sensitivity among consumers.

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Financial Trajectory and Forecast

Current Revenue Streams
Kybella, the leading DCA formulation, generated approximately USD 340 million globally in 2021, representing a significant share of the non-surgical fat reduction market. Its revenue trajectory reflects both organic growth and market expansion into new geographies.

Growth Projections
Analysts project the DCA market to grow at a CAGR of 12–15% through 2030, driven by increased adoption, expanding indications, and product pipeline innovations. The compound growth is also supported by emerging markets, where aesthetic surgeries are gaining popularity.

Emerging Markets
Asia-Pacific and Latin America exhibit substantial growth potential, propelled by rising disposable income and shifting beauty standards. Local approval processes speed up market entry, with companies investing heavily in market education and clinician training.

Pipeline and Innovation
Manufacturers explore reformulations with longer-lasting effects, fewer treatments, or targeted delivery systems, which could command premium pricing. Integration of DCA in combination therapies for enhanced fat reduction further boosts revenue prospects.

Market Risks
Economic downturns, regulatory delays, or safety controversies could dampen growth. Additionally, patent expirations and generic formulations could intensify price competition.

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Strategic Opportunities

• Product Diversification: Exploring DCA applications for other localized fat deposits (e.g., thighs, arms).
• Combination Treatments: Synergizing DCA with neurotoxins or skin tightening agents enhances efficacy and broadens customer appeal.
• Geographic Expansion: Entering emerging markets with tailored pricing strategies and local regulatory engagement.

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Conclusion

Deoxycholic acid stands at a compelling crossroads within the global aesthetic medicine landscape. The confluence of technological innovation, societal trends, and regulatory acceptance fosters significant growth potential. However, navigating intensifying competition and safety considerations is essential for sustained financial success. Companies capable of accelerating product innovation, expanding geographic reach, and establishing strong clinical data will likely derive the greatest value from DCA's promising market trajectory.

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Key Takeaways

• The global fat reduction market, driven by non-invasive procedures, is expanding rapidly, with DCA playing a pivotal role, particularly in submental fat reduction.
• Regulatory approvals and societal trends favoring minimally invasive aesthetic treatments position DCA for continued growth.
• Revenue growth hinges on geographic expansion, pipeline innovation, and addressing safety and pricing challenges.
• Competitive pressure necessitates strategic differentiation, including combination therapies and personalized treatment protocols.
• Market entrants should focus on emerging markets with tailored approaches to capitalize on shifting demographic preferences.

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FAQs

1. What is the primary medical use of deoxycholic acid?
Deoxycholic acid is primarily used for non-surgical reduction of submental fat, marketed under brands like Kybella. It destroys fat cells through a process called lipolysis, resulting in a more contoured appearance.

2. How does deoxycholic acid compare to other fat reduction methods?
DCA offers a minimally invasive alternative to liposuction and cryolipolysis, with advantages including outpatient procedures and targeted treatment. However, it typically requires multiple sessions and can have side effects like swelling and numbness.

3. Which regions present the greatest growth opportunities for DCA?
Emerging markets in Asia-Pacific and Latin America offer significant growth potential due to rising disposable incomes and increased aesthetic awareness. Regulatory approvals there are accelerating.

4. What are the main challenges facing the DCA market?
Key challenges include safety concerns, competition from alternative modalities, high treatment costs, and regulatory hurdles. Managing adverse effects and demonstrating long-term efficacy are critical.

5. What future innovations could impact DCA’s market trajectory?
Development of longer-lasting formulations, combination therapy protocols, and broader indications for fat deposits could further boost DCA’s market share and revenues.

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References

[1] American Society of Plastic Surgeons. "2019 Plastic Surgery Statistics."
[2] Grand View Research. "Fat Reduction Market Size & Trends."
[3] FDA. "FDA Approves Kybella for Double Chin."
[4] MarketWatch. "Aesthetic Medicine Market Forecast."
[5] Allergan. "Kybella Product Literature."