Last Updated: June 21, 2026

DEOXYCHOLIC ACID Drug Patent Profile


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When do Deoxycholic Acid patents expire, and what generic alternatives are available?

Deoxycholic Acid is a drug marketed by Wilshire Pharms Inc and is included in one NDA.

The generic ingredient in DEOXYCHOLIC ACID is deoxycholic acid. There are thirty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the deoxycholic acid profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Deoxycholic Acid

A generic version of DEOXYCHOLIC ACID was approved as deoxycholic acid by WILSHIRE PHARMS INC on April 2nd, 2021.

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Recent Clinical Trials for DEOXYCHOLIC ACID

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SponsorPhase
Wuhan No.1 HospitalPHASE2
The Fifth Hospital of WuhanPHASE2
Hubei Hospital of Traditional Chinese MedicinePHASE2

See all DEOXYCHOLIC ACID clinical trials

Medical Subject Heading (MeSH) Categories for DEOXYCHOLIC ACID
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
Wilshire Pharms Inc DEOXYCHOLIC ACID deoxycholic acid SOLUTION;SUBCUTANEOUS 212296-001 Apr 2, 2021 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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