Last updated: March 13, 2026
What Is NDC 00299-5890?
NDC 00299-5890 is a unique identifier for Triheptanoin (Dojolvi), a medical food used as an adjunct therapy for managing long-chain fatty acid oxidation disorders. It is marketed by Ultragenyx Pharmaceutical. Approved by the FDA in 2019, Dojolvi is prescribed to patients with specific metabolic conditions.
Market Size and Demographics
Indications and Patient Population
- Target Conditions: Long-chain fatty acid oxidation disorders (LC-FAOD)
- Prevalence: Estimated at 1 in 250,000 to 1 in 300,000 globally, with higher prevalence in certain populations.
- Estimated Patient Count: In the U.S., approximately 400-500 patients are eligible for treatment based on current diagnosis rates.
Key Market Drivers
- Expansion of newborn screening programs
- Increased awareness among metabolic specialists
- Limited alternative treatments for LC-FAOD
- Off-label uses under investigation for other metabolic disorders
Market Channels
- Specialty pharmacies
- Metabolic clinics
- Hospital outpatient pharmacies
Competitive Landscape
Direct Competitors and Alternatives
| Drug |
Indication |
Approval Year |
Market share (estimated) |
Price (per unit) |
| No approved alternative |
Long-chain fatty acid oxidation disorders |
2019 |
Dominant (initially) |
~$8,000/100 mL for 25kcal/mL |
| Off-label use of MCT oils |
Metabolic support products |
- |
Low |
~$50-150/month (over-the-counter) |
| Experimental therapies |
Under clinical trials |
- |
N/A |
N/A |
Market Entry and Penetration
Dojolvi's market penetration has been gradual due to the rarity of the condition and limited awareness. As of 2023, sales are estimated between $20-40 million annually in the U.S.
Price Trends and Projections
Historical Pricing Trends
- Initial launch price (2019): Approximately $8,000 per 100 mL.
- Price adjustments: Minor increases (~3-5%) annually, driven by manufacturing costs and label expansions.
Future Price Projections (2023-2028)
| Year |
Expected Price per 100 mL |
Key Influences |
| 2023 |
$8,400 |
Stable with minor inflation |
| 2024 |
$8,700 |
Anticipated manufacturing cost rises |
| 2025 |
$9,000 |
Potential market expansion; payor negotiations |
| 2026 |
$9,300 |
Possible new indications; reimbursement pressures |
| 2027 |
$9,600 |
Greater adoption; inflation adjustments |
Factors Impacting Price
- Reimbursement policies: Payers may negotiate discounts or utilize formulary strategies to contain costs.
- Market expansion: Broader indications or off-label uses can affect pricing.
- Manufacturing costs: R&D and production cost increases influence retail pricing.
- Generic or biosimilar entry: Limited for rare disease drugs; unlikely within forecast period.
Regulatory and Policy Impact
- Pricing regulations: US policies focus on transparency and value-based arrangements, possibly applying pressure to stabilize or reduce prices.
- Orphan drug status: Confers market exclusivity through 2024, delaying generic competition.
Key Market Opportunities
- Expanding indication scope to other fatty acid oxidation disorders
- Formulation improvements to reduce treatment volume
- Competitive pricing strategies to gain market share
- Collaborations with payers for value-based pricing
Key Risks
- Slow adoption due to the small patient population
- Pricing pressures from payers as awareness grows
- Potential development of alternative therapies or gene editing solutions
Summary
Dojolvi remains the primary therapy for LC-FAOD, with a current annual market size near $30 million in the U.S. Price stability is expected through 2025 with minor incremental increases. Market growth may be constrained by the rarity of the disorders and payer negotiations, but expansion into new indications offers potential upside.
Key Takeaways
- NDC 00299-5890 (Dojolvi) is a rare disease drug with limited but growing demand.
- Current pricing is approximately $8,400 per 100 mL, with projected increases of about 3-4% annually until 2025.
- The market is characterized by limited competition, with primary growth driven by diagnosis rates and expanded clinical use.
- Regulatory exclusivities help sustain pricing but may face pressure from evolving reimbursement policies.
- Future growth hinges on expanding indications, improving formulations, and managing payer negotiations.
FAQs
Q1: What is the main driver of the market for NDC 00299-5890?
The primary driver is the diagnosis and identification of long-chain fatty acid oxidation disorders, which are rare metabolic conditions.
Q2: How does the pricing of Dojolvi compare to other rare metabolic drugs?
Dojolvi is priced around $8,400 per 100 mL, comparable to other specialty metabolic therapies that range from $7,000 to $10,000 per month.
Q3: What are the primary regulatory factors affecting pricing?
Market exclusivity through orphan drug designation and potential changes in payer reimbursement strategies influence pricing stability.
Q4: Are there any upcoming pipeline therapies that could impact the market?
Current pipeline therapies are limited, with no major late-stage candidates competing directly against Dojolvi as of 2023.
Q5: What strategies might pharmaceutical companies adopt to expand market share?
Strategies include seeking label expansions, developing better formulations, negotiating value-based agreements, and increasing awareness among clinicians.
References
- Food and Drug Administration. (2019). FDA approves Dojolvi for long-chain fatty acid oxidation disorders. https://www.fda.gov
- IQVIA. (2022). Specialty drug market data.
- Ultragenyx Pharmaceuticals. (2023). Dojolvi product website.
- EvaluatePharma. (2022). Orphan and rare disease market report.
