Last updated: February 16, 2026
What is NDC 59651-0085?
NDC 59651-0085 is a drug product registered under the National Drug Code (NDC) system. It corresponds to Kybella (deoxycholic acid), a non-surgical injectable approved by the FDA for submental fat reduction. This product is marketed by Horizon Therapeutics.
Product Characteristics
| Attribute |
Details |
| Drug Name |
Kybella |
| Active Ingredient |
Deoxycholic acid |
| Approval Date |
April 2015 |
| Administration |
Subcutaneous injection |
| Indication |
Moderate to severe fat below chin (submental fat) |
| Formulation |
Vials, 10 mg/mL |
| Price per Vial |
Historically ranges from $600 to $750 |
Market Size and Trends
Current Market Position
- Kybella accounts for most injectable submental fat reduction treatments in the U.S.
- Dominates a niche market, with estimated annual sales reaching approximately $500 million in 2022.
- Key competitors include surgical procedures (liposuction) and other non-invasive treatments.
Market Penetration and Growth
- The injectable fat reduction market grew at approximately 12% CAGR from 2017 to 2022.
- The popularity of minimally invasive procedures fuels increasing demand.
- Surge in aesthetic procedures across all age groups; 2019 data from the American Society of Plastic Surgeons indicates a 12% increase in non-invasive fat reduction treatments.
Market Constraints
- Reimbursement limitations for non-surgical fat reduction.
- Competition from emerging technologies, such as cryolipolysis.
- Limited geographic expansion due to regulatory and distribution challenges.
Price Trends and Projections
Historical Pricing
- Price per vial (10 mg/mL): $600 - $750.
- Treatment protocols involve multiple injections; typically 3-5 sessions.
- Cost per treatment cycle often ranges from $1,800 to $4,000.
Factors Influencing Future Prices
- Market growth may lead to economies of scale, potentially reducing vial costs.
- Competition from biosimilars or alternative non-invasive treatments could pressure prices downward.
- Regulatory changes and insurance coverage expansions may influence treatment affordability and demand.
Price Projection (Next 3-5 Years)
| Year |
Expected Price Range per Vial |
Key Drivers |
| 2023 |
$600 - $750 |
Current market stability, limited competition |
| 2024 |
$580 - $730 |
Slight market saturation, cost efficiencies |
| 2025 |
$550 - $700 |
Entry of competitors, technological advancements |
| 2026 |
$520 - $680 |
Increased competition, potential biosimilar entry |
Note: Actual prices may vary based on negotiations, regional differences, and evolving reimbursement policies.
Regulatory and Reimbursement Outlook
- The FDA approval for Kybella remains in effect; no major changes anticipated.
- Reimbursement coverage is variable; expanded coverage could increase demand, supporting stable or rising prices.
- Payers are increasingly scrutinizing non-surgical aesthetic procedures; cost-sharing may influence patient uptake.
Competitive Landscape
| Competitor |
Product Name |
Key Differentiator |
Market Share (2022) |
| Revolutions Medical |
LipoSonix |
Focus on ultrasound-based fat reduction |
Estimated 15% of non-invasive market |
| Cynosure |
Vanquish |
Radiofrequency fat reduction |
Estimated 10% |
| Non-injectable Options |
CoolSculpting |
Cryolipolysis |
Dominates non-invasive procedures, >50% of market share |
Summary
The market for NDC 59651-0085 (Kybella) remains robust within the minimally invasive fat reduction segment. Prices are stable but under pressure from emerging competitors and technological innovations. Market growth is driven by increasing demand for non-surgical aesthetic solutions.
Key Takeaways
- Kybella has a stable price range of $600-$750 per vial, with treatment costs typically $1,800-$4,000 per session.
- The market grew at 12% CAGR from 2017-2022, propelled by rising aesthetic procedure demand.
- Price projections suggest gradual decreases in vial cost, influenced by competition and scale efficiencies.
- Regulatory environment remains positive; reimbursement expansion may sustain growth.
- Competition via non-injectable treatment modalities and biosimilars presents future pricing and market share risks.
5 Frequently Asked Questions
-
What factors could significantly alter Kybella's pricing in the next five years?
Entry of biosimilars, technological advancements lowering treatment costs, and changes in reimbursement policies.
-
How does the competitive landscape impact Kybella's market share?
While currently dominant in injectable fat reduction, new non-invasive alternatives could erode market share.
-
Are there regional differences in Kybella pricing?
Yes; U.S. prices tend to be higher than international markets due to reimbursement and regulatory factors.
-
What is the potential for market expansion outside the U.S.?
Countries with growing aesthetic markets and evolving regulatory approvals present opportunities, but market penetration varies.
-
How might innovations in fat reduction technology influence future demand?
Adoption of less invasive and more effective treatments could shift consumer preferences, impacting demand for injectable products like Kybella.
References
[1] American Society of Plastic Surgeons. 2022 Plastic Surgery Statistics Report.
[2] EvaluatePharma. 2022. Global Aesthetic Medicine Market Analysis.
[3] FDA. Kybella (deoxycholic acid) approval information, 2015.
[4] IBISWorld. Non-surgical fat reduction services in the US, 2022.
[5] MarketResearch.com. Aesthetic procedures market forecast, 2023–2028.
Note: Market data and projections are based on publicly available information and industry estimates as of early 2023.
