Last updated: February 21, 2026
What is NDC 16714-0763?
NDC 16714-0763 identifies a specific drug product in the National Drug Code (NDC) database. Based on available data, this code corresponds to Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy indicated for spinal muscular atrophy (SMA).
Market Overview
Product Profile
- Manufacturer: Novartis
- Approval Date: May 24, 2019 (FDA)
- Indication: SMA in pediatric patients less than two years of age
- Delivery: Single infusion
- Price: Estimated wholesale acquisition cost (WAC) of $2.1 million per dose as of 2023
Market Size and Demand Drivers
- Target Population: SMA occurs in approximately 1 in 10,000 live births.
- Prevalence in the US: Estimated at 9,000 to 10,000 patients, with roughly 350 new cases annually.
- Market Penetration: Limited by high cost, regulatory approvals, and reimbursement challenges.
- Competitive Landscape: No direct competitors with comparable gene therapies for SMA as of 2023. Prior treatments include nusinersen (Spinraza) with annual costs around $750,000 and risdiplam (Evrysdi) at approximately $340,000 annually, primarily as ongoing formulations rather than one-time treatments.
Price Projections
Current Price Setting Dynamics
- Pricing Model: Premium pricing justified by the single-dose therapy and long-term efficacy.
- Market Access: Price negotiations with payers influence net pricing, potentially reducing actual reimbursement below WAC.
Market Growth Drivers
- Increasing Diagnoses: Newborn screening improves early detection.
- Expanded Approvals: Potential for broader indications or age range approval could expand market size.
- Pricing Trends: Growing acceptance of high-cost gene therapies in healthcare systems.
Future Price Trends (2024-2028)
| Year |
Estimated Wholesale Price (WAC) |
Notes |
| 2024 |
$2.1 million |
Baseline; sustained by market acceptance and manufacturing costs |
| 2025 |
$2.2 million |
Slight increase driven by inflation and manufacturing improvements |
| 2026 |
$2.3 million |
Potential price stabilization or marginal increase due to market expansion |
| 2027 |
$2.3 million |
Price plateau as payer negotiations mature |
| 2028 |
$2.3 million |
Long-term stability; market saturation limits further escalation |
Key Factors Impacting Price Trajectory
- Reimbursement Policies: Growing utilization could pressure prices downward.
- Manufacturing Costs: Technological advancements could reduce production expenses, enabling price adjustments.
- Regulatory Changes: Expanded indications or new approval data might influence pricing strategies.
- Market Competition: Absence of direct competitors supports sustained high pricing; emergence of competitors would impact price.
Market Penetration and Revenue Projections
| Year |
Estimated Patients Treated |
Revenue (assuming 100% penetration) |
| 2024 |
1,000 |
$2.1 billion |
| 2025 |
1,200 |
$2.64 billion |
| 2026 |
1,400 |
$3.22 billion |
| 2027 |
1,600 |
$3.68 billion |
| 2028 |
1,800 |
$4.14 billion |
Real-world uptake will likely be lower due to market barriers, reimbursement issues, and patient eligibility.
Strategic Considerations
- Pricing negotiations with payers will impact net revenue.
- Market expansion depends on regulatory approval for broader indications.
- Pipeline developments may influence both competition and pricing.
Key Takeaways
- NDC 16714-0763 corresponds to Zolgensma, a high-value gene therapy for SMA.
- Current WAC stands at approximately $2.1 million, with modest increases projected to 2028.
- Market size remains constrained by the genetic disorder’s prevalence, but expanding diagnostic protocols could increase demand.
- Reimbursement negotiations and regulatory shifts will significantly influence actual net prices and revenue streams.
FAQs
1. How does Zolgensma pricing compare with other SMA treatments?
Zolgensma's single-dose price of approximately $2.1 million exceeds initial annual costs for treatments like Spinraza (~$750,000 annually) and Evrysdi (~$340,000 annually). However, its one-time administration potentially reduces long-term treatment costs.
2. What factors could cause Zolgensma's price to decrease?
Market competition, manufacturing improvements, and payer pressure could reduce net prices. Expanded indications may also lead to pricing adjustments based on volume and clinical data.
3. Are there indications for price reductions or discounts?
Pricing discounts are common through payer negotiations, risk-sharing agreements, and outcomes-based contracts, especially as the therapy becomes more widely adopted.
4. What is the potential market size for NDC 16714-0763 in the coming years?
Initially, around 350 new SMA cases annually in the U.S., with growth driven by improved diagnosis and expanded access. Total treatable patients could increase to roughly 1,500 nationwide over five years.
5. How might regulatory developments influence future pricing?
If additional indications are approved or if new data demonstrate broader effectiveness, pricing power may increase. Conversely, regulatory pressures to control healthcare costs could limit price escalations.
References
[1] U.S. Food and Drug Administration. (2019). FDA approves Zolgensma for pediatric patients less than 2 years of age with SMA.
[2] Novartis. (2023). Zolgensma prescribing information.
[3] IQVIA. (2023). National drug pricing reports.
[4] Center for Drug Evaluation and Research. (2021). SMA treatment market analysis.
