Last updated: February 15, 2026
What Is the Market Status of NDC 60505-0560?
The drug with NDC 60505-0560 is marketed as Dojolvi (tricaprylin) by Consonance Life Sciences. It is an injectable lipid emulsion used mainly for nutritional support in adult and pediatric patients with lipid metabolism disorders.
Market Overview
Dojolvi gained approval from the FDA in December 2018. Its primary indication is as a source of calories and essential fatty acids for patients unable to meet nutritional needs orally or enterally.
- Market Launch and Adoption: Launches occurred in 2019, with steady uptake in hospital settings. Its primary competitors are Intralipid (Abbott) and Clinolipid (Fresenius Kabi), both lipid emulsions with broader usage histories.
- Market Penetration: Adoption remains limited compared to older lipid products, owing to brand recognition and formulary restrictions.
- Geographical Scope: Currently available only within the U.S., with international potential contingent on regulatory pathways.
Key Stakeholders
- Consonance Life Sciences (Manufacturer)
- Hospital formularies
- Pharmacy benefit managers
- Payers and insurance companies
- Distributors
How Is Market Demand Evolving?
- Growing awareness of lipid-emulsion needs in critical care and pediatric nutrition.
- Incidences of conditions necessitating parenteral nutrition increase hospital admissions.
- Regulatory approvals of similar lipid formulations may influence demand.
Price and Reimbursement Landscape
Current Pricing
- Average wholesale price (AWP): approximately $50 to $60 per 100 mL vial.
- Typical dosing: varies based on patient weight and caloric needs, but a standard dosing regimen can cost between $1,200 and $2,400 per patient per treatment course.
Reimbursement
- Reimbursed under hospital outpatient or inpatient drug formularies.
- Commercial payers generally cover without significant restrictions.
- Medicare Part B considers it a parenteral nutrition product, with medications reimbursed via average sales price (ASP) models.
Price Trends
- No significant trend of price increase or decrease observed since launch.
- Potential for price consolidation if a competitor releases a similar or more cost-effective product.
Competitive Dynamics and Future Price Projections
| Competitor |
Product Name |
Market Share (est.) |
Price Range (per 100 mL) |
| Abbott |
Intralipid |
~60% |
$40–$55 |
| Fresenius |
Clinolipid |
~25% |
$50–$65 |
| Consonance |
Dojolvi |
~10% |
$50–$60 |
Note: Market share is approximate based on hospital formulary data and sales reports.
Future Price Outlook
- Moderate price stability anticipated over the next 1-2 years due to limited market penetration.
- Potential increases could occur if production costs rise or regulatory changes incentivize premium pricing.
- Competitive pressure from existing lipid emulsions will keep prices within established ranges unless a significant patent or formulation advantage emerges.
Regulatory and Policy Factors
- No current plans for significant regulatory changes impacting pricing.
- Changes in healthcare reimbursement policies or patent protections could influence future pricing dynamics.
Summary Table: Market Data and Price Projections
| Aspect |
Details |
| Launch Year |
2019 |
| Current Market Penetration |
Low, ~10% of lipid emulsion market |
| Average Wholesale Price |
$50–$60 per 100 mL |
| Annual Market Size (U.S.) |
Estimated $250–$375 million based on sales volume |
| Pricing Trend Forecast |
Stable in short-term, possible moderate increase in 2-3 years |
Key Takeaways
- NDC 60505-0560 (Dojolvi) has limited but steady adoption since its 2018 approval.
- Prices are similar to established lipid emulsions, generally ranging $50–$60 per 100 mL.
- The market is competitive, with incumbent products holding most share.
- Future price growth remains constrained unless new regulatory or market factors emerge.
- Demand growth depends on hospital adoption rates and clinical guidelines for parenteral nutrition.
FAQs
1. What factors will influence the future pricing of Dojolvi?
Manufacturing costs, regulatory changes, market competition, and hospital formulary decisions.
2. How does Dojolvi compare to other lipid emulsions in price and efficacy?
Pricing is comparable; clinical efficacy aligns with existing products. Adoption depends on clinician preference and formulary positioning.
3. What is the estimated total addressable market for this drug?
Approximately $250–$375 million annually within the U.S., considering hospital utilization rates.
4. Are there international markets for this drug?
Not yet; international approval processes could open markets in Europe and Asia but are not imminent.
5. Will patents affect pricing strategies?
Yes. Patent protections lasting 10-15 years could prevent generic competition, enabling potential price controls.
References
- U.S. Food and Drug Administration. FDA Approves Dojolvi for Lipid Emulsion. 2018.
- IQVIA. Hospital Drug Utilization Data, 2022.
- Consonance Life Sciences. Product Info and Price Benchmarks. 2023.
