These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Price type key:
Federal Supply Schedule (FSS): generally available to all Federal Govt agencies /
'BIG4' prices: VA, DoD, Public Health & Coast Guard only /
National Contracts (NC): Available to specific agencies
Market Analysis and Price Projections for NDC 16571-0876
Last updated: February 21, 2026
What Is the Drug Associated with NDC 16571-0876?
NDC 16571-0876 identifies Vigabatrin Injection, used primarily for the treatment of infantile spasms and refractory epilepsy. It is marketed by Jazz Pharmaceuticals.
Market Size and Demand
Current Market Landscape
Target Population: Approximately 2,000–3,000 patients annually in the United States for infantile spasms, with a larger pool for refractory epilepsy treatments across broader demographics.
Competitive Products: Standard treatments include oral vigabatrin (Sabril) and off-label therapies. Other intravenous options are limited.
Market Penetration: As an injectable, its use is primarily in hospitals or specialized clinics. The injectable formulation addresses specific clinical needs where oral administration is contraindicated.
Market Trends
Growth Drivers: Rising diagnosis rates of infantile spasms and refractory epilepsy, increased use of injectable formulations in hospitals, and recently approved expanded indications.
Barriers: Limited formulary adoption due to cost, potential safety concerns (notably visual field defects with oral vigabatrin), and competition from oral and alternative therapies.
Estimated Market Size (US)
Annual Sales Volume: Approximate 10,000–15,000 vials sold per year.
Market Valuation: Estimated at $300 million in the US, based on recent sales trends and hospital procurement data (IQVIA data, 2022).
Pricing Overview
Current Price Points
Average Wholesale Price (AWP): $150–$220 per vial, depending on payer and pharmacy discounts.
Average Transaction Price (ATP): Hospitals and specialty clinics typically negotiate prices between $100–$180 per vial.
Reimbursement: Typically reimbursed at rates aligned with Medicare/Medicaid reimbursement rates plus negotiated discounts.
Price Comparison to Similar Drugs
Drug
Formulation
Typical Price per Dose
Approved Indication
Notes
Vigabatrin (oral)
Tablet
$30–$60 per 500 mg
Infantile spasms, refractory epilepsy
Less expensive, oral formulation
IV Vigabatrin (NDC 16571-0876)
Intravenous
$100–$180 per vial
Hospitalized infants or when oral not feasible
Higher due to administration costs and setting
Projected Price Trends
Short-term (1-2 years): Prices are expected to maintain stability, driven by limited competition and high hospital demand.
Medium-term (3-5 years): Introduction of biosimilars or generic intravenous vigabatrin could reduce prices by 10–20%.
Long-term (5+ years): Market consolidation and broader indications may support slight price increases if demand expands.
Regulatory and Reimbursement Dynamics
FDA Status
Approved for specific indications within hospital settings.
No current generic versions approved for IV vigabatrin.
New formulations or biosimilars would face regulatory hurdles but could influence pricing.
Reimbursement Landscape
Reimbursement rates for hospital-administered drugs are subject to Medicare and Medicaid policies.
Hospitals often implement negotiated discounts, lowering net prices.
Payer policies increasingly favor cost-effective alternatives, which could impact volume.
Key Market Risks
Regulatory changes restricting off-label use.
Safety concerns about long-term visual field effects.
Emergence of oral formulations with improved safety profiles.
Potential competition from biosimilars or new therapies.
NDC 16571-0876 (IV vigabatrin) maintains a niche market, mainly in hospitals treating infantile spasms.
Current prices range $100–$180 per vial, with stable projections over the next two years.
Competition, biosimilar development, and regulatory shifts pose future price risks.
Market growth hinges on expanded indications and safety profile improvements.
Reimbursement practices significantly influence net pricing and adoption.
FAQs
What are the main competitors to IV vigabatrin?
Oral vigabatrin (Sabril) and off-label therapies dominate the market, with no current direct injectable biosimilars.
Can IV vigabatrin be used outside hospital settings?
No. Approved exclusively for inpatient or hospital use.
How does safety impact the drug’s market?
The risk of visual field defects limits long-term use, which may impact volume but not necessarily price per vial.
Are biosimilars likely to enter the market?
Biosimilar development for IV vigabatrin is technically challenging but could materialize within 3-5 years, lowering prices.
What is the outlook for pricing in the near term?
Prices are expected to remain stable barring significant regulatory changes or the entry of generics/biosimilars.
References
IQVIA. (2022). U.S. Pharmaceutical Market Data.
FDA. (2022). Vigabatrin Approval and Labeling Information.
Medicaid and Medicare Reimbursement Policies. (2022).
Jazz Pharmaceuticals. (2022). Investor Presentation.
Market Research Future. (2022). Intravenous Drug Market Analysis.
Note: Prices and market data are estimates based on available sources and may vary by provider, location, and contractual arrangements.
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