Last updated: February 13, 2026
What is NDC 13668-0286?
NDC code 13668-0286 refers to a specific drug product registered within the US healthcare system. According to the FDA’s National Drug Code Directory, this identifier corresponds to Voxzogo (vosoritide), marketed for the treatment of achondroplasia, a form of dwarfism.
Market Overview
Indications and Patient Population
Voxzogo primarily treats achondroplasia in children aged 5 years and older. The estimated prevalence of achondroplasia in the US is approximately 4,000 to 6,000 patients. The target market extends globally, particularly in markets with established healthcare infrastructure and approval pathways.
Regulatory Status
Voxzogo received FDA approval in July 2021. Regulatory approvals in the European Union and other jurisdictions have followed or are pending. The drug's orphan drug designation supports exclusivity rights, typically lasting 7 years in the US, with potential extensions under certain conditions.
Market Size and Penetration
Estimates indicate initial US sales potential between $300 million and $500 million annually, assuming rapid adoption in eligible pediatric populations and ongoing off-label use. Market penetration depends on drug pricing, reimbursement policies, physician acceptance, and competitive landscape.
Competitive Landscape
Currently, no approved treatments specifically target achondroplasia. Management involves supportive care; thus, Voxzogo's entry introduces a novel, disease-modifying therapy. Competitors are research-stage biologics or gene therapies, but none has secured market approval.
Price Projections
Pricing Strategy
The wholesale acquisition cost (WAC) for Voxzogo is approximately $137,000 per year per patient, based on initial pricing disclosures. The price reflects the chronic administration, reconstituted therapy, and specialized delivery.
Cost Comparison and Reimbursement
- Similar orphan biologics, such as Zolgensma (SPINRAZA is another comparison), are priced between $2.1 million and $4.1 million for a course.
- Daily or monthly pricing models are common in similar chronic therapies for rare disorders.
Revenue Projections
| Year |
US Sales (millions) |
Global Sales (millions) |
Assumptions |
| 2023 |
$50 |
$70 |
Launch phase, 10-15% market share |
| 2024 |
$150 |
$250 |
Increased adoption, expanded coverage |
| 2025 |
$350 |
$500 |
Full market penetration, reimbursement stabilization |
These projections assume:
- Rapid payer acceptance
- Patient adherence
- Competitive landscape remains stable
- No significant price erosion
Price Sensitivity and Payer Policies
Reimbursement negotiations may influence the effective price. Payers may require discounts, especially in Medicaid and private insurance, potentially cutting net revenue by 20-30%.
Risks and Opportunities
- Risks: Off-label use, payer restrictions, unmet patient needs, potential competition.
- Opportunities: Expanding indications, combination therapies, international approval, and biosimilars.
Key Takeaways
- NDC 13668-0286 is Voxzogo, a treatment for achondroplasia approved in the US in July 2021.
- The US market potential exceeds $300 million annually, with global sales potentially doubling that figure.
- Initial pricing around $137,000/year per patient is in line with other orphan biologics.
- Sales growth depends on healthcare provider acceptance, payer coverage, and regulatory developments.
- Competition is limited but evolving; pricing pressures and reimbursement policies remain key factors.
FAQs
1. What factors influence Voxzogo’s pricing?
Healthcare provider costs, market demand, regulatory approvals, manufacturing expenses, and payer negotiations drive pricing decisions.
2. How does Voxzogo's market entry compare to similar orphan drugs?
Voxzogo’s initial pricing aligns with other biologic therapies for rare diseases, which often range from $100,000 to $200,000 annually.
3. What are the key risks to revenue projections?
Reimbursement restrictions, off-label use, emerging competitors, and unforeseen adverse events could impact sales.
4. Are there any international market considerations?
European regulators approved Voxzogo in 2022, expanding global access but subject to local pricing and reimbursement policies.
5. How might price erosion affect long-term projections?
Introduction of biosimilars, patent challenges, and payer pressure could lead to a 10-20% annual decrease in net prices over time.
References
- FDA Drug Approval Package – Voxzogo (vosoritide).
- IQVIA Contract Sales Data, 2022.
- Industry price reports and press releases.
- Market research reports on orphan biologics.
- European Medicines Agency approval documents.
