Last updated: February 26, 2026
What is NDC 58657-0524?
NDC 58657-0524 is a specific drug identified in the U.S. National Drug Code (NDC) system. This code corresponds to Voxzogo (vosoritide), a recombinant peptide developed by BioMarin Pharmaceutical for the treatment of achondroplasia, a genetic condition causing dwarfism.
Market Overview
Current Market Environment
Voxzogo received FDA approval on July 1, 2021, for pediatric patients aged 5 years and older with achondroplasia. The drug targets a niche market with limited competition, mainly other experimental or off-label therapies.
Market Need
Achondroplasia affects approximately 1 in 15,000 to 40,000 individuals globally. The U.S. market is estimated at around 80,000 to 125,000 patients. Currently, there are no approved disease-modifying medications, with treatment primarily focusing on symptomatic management.
Competitive Landscape
- Existing therapies: Growth hormone has been used off-label but shows limited efficacy.
- Pipeline drugs: Several companies are researching drugs targeting fibroblast growth factor receptor 3 (FGFR3). None are yet approved for this indication.
Market Drivers
- FDA approval of Voxzogo created a new treatment paradigm.
- Increased awareness of achondroplasia and related genetic testing.
- Potential eventual expansion to adult populations.
Price Strategy and Revenue Projections
Current Pricing
BioMarin priced Voxzogo at $385,000 annually per patient upon launch. The price reflects high developmental costs and the small target population.
Insurance and Reimbursement
- Reimbursement depends on insurance coverage.
- Biologic drugs typically have favorable coverage due to chronic nature and lack of alternatives.
- Medicare and Medicaid coverage vary; negotiations influence final patient access.
Revenue Projections Over the Next 5 Years
| Year |
Estimated Patients (U.S.) |
Market Penetration |
Revenue (USD millions) |
| 2022 |
3,000 |
4% |
1,155 |
| 2023 |
4,000 |
6% |
2,310 |
| 2024 |
5,000 |
8% |
3,850 |
| 2025 |
6,000 |
10% |
4,620 |
| 2026 |
7,000 |
12% |
5,410 |
Assumptions: Steady growth in prevalence and market penetration, with gradual uptake reflecting clinical data, insurance approvals, and physician adoption.
Price Adjustment Factors
- Potential discounts for payers.
- International pricing variations.
- Pipeline competition may exert downward pressure.
Regulatory and Policy Impact
- Broader approval for adult populations is under review.
- Health policy initiatives promoting rare disease treatments could expand access.
- Price control policies may influence future pricing strategies.
Key Takeaways
- NDC 58657-0524 is associated with Voxzogo (vosoritide), approved since 2021.
- Market size begins at a few thousand patients in the U.S., with revenue potential surpassing $4 billion annually with expanded access.
- Pricing remains high at launch, with potential for discounts as payers negotiate.
- Revenue growth depends on market penetration, insurance coverage, and competition.
- The evolving regulatory landscape and pipeline drugs will influence long-term pricing and market share.
FAQs
Q1: Is Voxzogo approved outside the U.S.?
Currently, it is approved only in the U.S. FDA. Regulatory review processes are ongoing in other territories.
Q2: What factors could affect price projections?
Market competition, policy changes, payer negotiations, and potential expanded indications can influence pricing.
Q3: How many patients are expected to enroll in clinical trials?
Approximately 1,500 to 2,000 patients globally are expected to participate in ongoing or planned trials assessing broader indications.
Q4: Will prices decrease with market expansion?
Possible, as discounts and negotiations increase and market entry of biosimilars or generics does not occur due to the complex biologic nature.
Q5: Are there alternative therapies in development?
Yes, several companies are developing FGFR3 inhibitors and related biologics, but none have yet received regulatory approval.
Sources:
[1] U.S. Food and Drug Administration. (2021). FDA Approves Voxzogo to Treat Children with Achondroplasia.
[2] BioMarin Pharmaceutical Inc. (2021). Voxzogo (vosoritide) Prescribing Information.
[3] IQVIA. (2022). U.S. Biopharmaceutical Market Data.
[4] Fierce Pharma. (2022). Rare Disease Drug Pricing Strategies.
[5] EvaluatePharma. (2022). Global Market Forecasts for Rare Disease Treatments.
