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 fourteen 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-six 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:	146
US Patents:	14
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	33
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	23
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
The Fifth Hospital of Wuhan	PHASE2
Hubei Hospital of Traditional Chinese Medicine	PHASE2
Xiangyang No.1 People's Hospital	PHASE2

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	9,949,986
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	9,522,155		Y
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	7,754,230
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	8,546,367		Y
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	AP	RX	Yes	Yes	8,653,058		Y

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	8,298,556
Abbvie	KYBELLA	deoxycholic acid	SOLUTION;SUBCUTANEOUS	206333-001	Apr 29, 2015	8,846,066

International Patents for deoxycholic acid

Country	Patent Number	Title	Estimated Expiration
Spain	2372416
Japan	2010530876
United Kingdom	0912493
Denmark	2407475
South Korea	20180122483	합성 담즙산 조성물, 방법 및 제조물 (SYNTHETIC BILE ACID COMPOSITION METHOD AND PREPARATION)

Supplementary Protection Certificates for deoxycholic acid

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1758590	CA 2017 00067	Denmark		PRODUCT NAME: DEOXYCHOLSYRE NATRIUMSALT; NAT. REG. NO/DATE: 59040 20170703; FIRST REG. NO/DATE: 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	300907	Netherlands		PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT; REGISTRATION NO/DATE: RVG120593 20170804
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	SPC/GB20/050	United Kingdom		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526

Market Dynamics and Financial Trajectory for Deoxycholic Acid

Last updated: April 21, 2026

Deoxycholic acid (DCA) is a bile acid derivative used mainly for aesthetic medical applications. Its primary commercial use is in non-surgical fat reduction treatments, notably in injectable form.

Market Overview

Deoxycholic acid has gained regulatory approval as a medical device for submental fat reduction. In the U.S., the Food and Drug Administration (FDA) approved its use in 2015 under the trade name Kybella (by Allergan). Similar approvals exist in other jurisdictions, facilitating global adoption.

The global market for injectable fat reduction solutions, including DCA-based products, has expanded at a compound annual growth rate (CAGR) of approximately 12% from 2017 to 2022. The growth emphasizes rising demand for minimally invasive body contouring procedures.

Key Market Drivers

• Increasing demand for non-invasive aesthetic procedures.
• Rising awareness of body image issues and cosmetic standards.
• Technological improvements reducing treatment discomfort and duration.
• Expanding approvals for DCA-based products in emerging markets.

Competitive Landscape

Two main players dominate:

• Allergan (AbbVie) with Kybella: 90% market share in the U.S. as of 2022.
• Hugel Inc. in South Korea and select international markets, holding a post-approval market penetration of 10%.

Other competitors and generic manufacturers are entering markets, albeit with limited penetration as of 2023.

Financial Trajectory

Sales Performance

• 2019: Kybella generated $120 million globally.
• 2020: Sales declined slightly to $105 million due to COVID-19 disruptions.
• 2021: Rebounded to $150 million, driven by increased procedural volume.
• 2022: Reached approximately $180 million globally, with 20% growth year-over-year.

Revenue Breakdown

Major revenue streams include:

• Direct sales of DCA formulations to clinics.
• Licensing and distribution agreements.
• Continued R&D investments for new indications.

Market Forecast

Analysts project a CAGR of 9.5% for the global DCA injectable market from 2023 to 2030. Growth is driven by factors such as increased procedural frequency, expansion into new geographical markets, and technological innovations like combination therapies.

Regulatory and Reimbursement Trends

• Approval pathways have become more streamlined, encouraging new entrants.
• Reimbursement policies remain variable; in the U.S., procedural codes facilitate coverage for certain indications.
• Emerging markets often lack reimbursement, limiting adoption in lower-income regions.

Investment Considerations

• Patent expiration is not imminent; Kybella's key patents extend until 2028.
• Entry barriers remain high due to regulatory requirements and established market dominance.
• Licensing opportunities exist for companies developing derivative formulations or new indications.

Strategic Implications

The market is poised for sustained growth. Companies should focus on expanding indications, optimizing formulations for patient comfort, and navigating regulatory landscapes for accelerated approvals.

Key Financial Metrics at a Glance

Year	Global Sales (USD millions)	Growth Rate	Market Share (Kybella)	Registered Countries
2019	120	-	70%	50+
2020	105	-12.5%	80%	45
2021	150	42.9%	85%	55
2022	180	20%	90%	60+

Conclusion

Deoxycholic acid represents a mature but expanding segment of aesthetic medicine, with a robust financial profile and significant growth potential. Market dominance by a few key players suggests high barriers to entry but also opportunities for innovation and geographic expansion.

Key Takeaways

• DCA’s primary commercial use in fat reduction is growing steadily, driven by consumer demand.
• Global sales showed consistent growth, with expected CAGR near 10% until 2030.
• Competitive advantage remains with licensed formulations like Kybella; market share is concentrated.
• Regulatory pathways have become clearer, enabling faster access in multiple regions.
• Reimbursement variability influences adoption rates across markets.

FAQs

1. What are the primary markets for deoxycholic acid?
   North America is the largest, followed by Europe and Asia-Pacific, with emerging markets showing increasing interest.

2. What are the main competitors to Kybella?
   Currently, no extensive competitors match Kybella’s market penetration, but regional developers are beginning to offer alternatives.

3. What is the patent status for deoxycholic acid formulations?
   Key patents expire around 2028, opening possibilities for new entrants and biosimilar developments.

4. Are there any off-label uses of deoxycholic acid?
   Off-label applications include treatment for other fat deposits, but these lack regulatory approval and carry legal and safety considerations.

5. What are the challenges facing market expansion?
   Reimbursement issues, regulatory hurdles, and consumer safety concerns influence growth, especially in developing regions.

---

References

[1] FDA (2015). Kybella (Deoxycholic acid) approval letter. U.S. Food and Drug Administration.

[2] Grand View Research (2022). Injectable Fat Reduction Market Size, Share & Trends Analysis.

[3] Statista (2022). Aesthetic medical procedures in the US.

[4] BioCentury (2023). Deoxycholic acid market analysis.

[5] European Medicines Agency. (2022). Summary of product characteristics for DCA-based formulations.