You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

DEOXYCHOLIC ACID Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for DEOXYCHOLIC ACID?
  • What are the global sales for DEOXYCHOLIC ACID?
  • What is Average Wholesale Price for DEOXYCHOLIC ACID?
Drug patent expirations by year for DEOXYCHOLIC ACID
Recent Clinical Trials for DEOXYCHOLIC ACID

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

SponsorPhase
Jingzhou Hospital of Traditional Chinese MedicinePHASE2
Yichang Hospital of Traditional Chinese MedicinePHASE2
Wuhan No.1 HospitalPHASE2

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

Deoxycholic Acid: Market Dynamics and Financial Trajectory Analysis

Last updated: February 15, 2026

Market Overview

Deoxycholic acid, a secondary bile acid, is used primarily in aesthetic medicine for non-invasive fat reduction procedures. It is marketed under invasive and non-invasive formulations, with a significant presence in the minimally invasive body contouring segment. Its regulatory approval status varies globally; the U.S. Food and Drug Administration (FDA) approved its injectable form (Kybella, marketed by Solta Medical) in 2015 for submental fat reduction.

Market Drivers

  1. Aesthetic Demand Expansion: Growth in demand for non-surgical body contouring treatments drives sales. Global non-invasive fat reduction medical procedures expanded at a Compound Annual Growth Rate (CAGR) of 8.3% from 2020-2025, according to MarketsandMarkets.

  2. Product Approvals and Regulatory Status: FDA approval of deoxycholic acid for submental fat is a significant driver in the U.S., with similar approvals in Europe and Asia-Pacific expanding market access.

  3. Technological Advances: Development of refined injection techniques and better patient targeting increase adoption and repeat procedures.

  4. Demographic Trends: Aging populations seek minimally invasive options for cosmetic improvement; younger demographics prefer non-invasive options.

Market Constraints

  1. Regulatory Variability: Approval status differs across countries, affecting market penetration. For instance, certain Asian markets are still evaluating licensing of deoxycholic acid products.

  2. Competition from Alternatives: Other fat reduction modalities like cryolipolysis (CoolSculpting) and laser lipolysis impose price and innovation pressure.

  3. Safety and Side Effects: Post-treatment adverse effects such as swelling, numbness, or uneven contours limit acceptance and repeat procedures.

  4. Pricing Pressures: Competitive pricing and reimbursement challenges hinder revenue growth potential in some regions.

Market Size and Revenue

The global market for deoxycholic acid-based treatments was valued at approximately USD 250 million in 2022, with projections reaching USD 500 million by 2028 (CAGR 12%). The U.S. accounts for over 70% of the sales, due to early product approval and high aesthetic medicine penetration.

Key Players and Market Share

Company Product Estimated Market Share (2022) Notes
Solta Medical Kybella 65% Only FDA-approved deoxycholic acid product
HUGEL Belkyra 10% Korean-market alternative
Other Emerging Players Multiple smaller brands 25% Varying regulatory statuses

Financial Trajectory

  • Revenue Growth: For major players, revenues increased by 25% YoY in 2022, driven by increased procedure volume and expanding geographic reach.
  • Profitability: Gross margins range from 70% to 80%, benefiting from high-margin product sales and minimal manufacturing costs.
  • Investments: R&D spending by key manufacturers increased 15% from 2021-2022, focusing on new formulations and expanded indications, such as body contouring beyond submental fat.

Regulatory and Policy Impact

Enhanced regulatory pathways in Asia-Pacific (e.g., China’s CFDA approvals) could accelerate market growth. Conversely, restrictions on off-label uses or new safety regulations could temper growth.

Emerging Trends and Outlook

  • Expansion into additional indications, such as generalized obesity or specific fat deposits.
  • Development of combination therapies with other minimally invasive treatments.
  • Growth in medical tourism influencing sales, particularly in Asia and Latin America.

Key Takeaways

  • The deoxycholic acid market is expanding at a CAGR of approximately 12% from 2022-2028.
  • U.S. market dominance stems from regulatory approval and established procedures.
  • Competitive landscape is consolidating, with Solta Medical controlling a significant share.
  • Regulatory variability and competition from alternative modalities constrain growth pathways.
  • Innovation and new indications will likely serve as primary growth catalysts.

FAQs

1. What is the primary use of deoxycholic acid?
Deoxycholic acid is used for minimally invasive fat reduction, primarily in submental areas (double chin).

2. What factors could hinder market growth?
Regulatory restrictions, competition from other fat reduction technologies, safety concerns, and pricing pressures limit growth.

3. How does regulatory approval influence market dynamics?
FDA approval in the U.S. greatly accelerates adoption and sales; lack of approval elsewhere restricts expansion.

4. Which regions are emerging markets for deoxycholic acid?
Asia-Pacific and Latin America are expanding due to increasing aesthetic procedures and regulatory approvals.

5. What are the future trends for this market?
Expansion into broader fat reduction applications, combination therapies, and increased medical tourism are key trends.

References

[1] MarketsandMarkets, "Non-Invasive Fat Reduction Market," 2022.
[2] U.S. FDA, "FDA approves Kybella for double chin treatment," 2015.
[3] GlobalData, "Aesthetic Medicine Market Report," 2022.
[4] Grand View Research, "Body Contouring Devices Market," 2021.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.