Last updated: February 12, 2026
Overview of NDC 58151-0126
NDC 58151-0126 is a pharmaceutical product marketed as Nayzilam (midazolam) nasal spray, 2.5 mg/actuation. It is indicated for the treatment of acute seizure clusters in patients aged 12 years and older. Approved by the FDA in 2019, Nayzilam addresses unmet needs in emergency seizure management, particularly in outpatient and home settings.
Current Market Position
Nayzilam entered the market amid competition from established seizure medications such as rectal diazepam and intranasal formulations like Diastat and Valtoco. It offers a needle-free, rapid administration route, which enhances usability and safety.
Market Size and Trends
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Target Population: Approximate 2 million epilepsy patients in the U.S., with roughly 1 million experiencing seizure clusters annually [[1]].
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Market Penetration: As of Q4 2022, Nayzilam holds approximately 8% of the emergency seizure adjunct market [[2]].
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Growth Drivers:
- Rising prevalence of epilepsy.
- Increased awareness of rapid, non-invasive treatment options.
- Prescription partner programs and insurance coverage expansion.
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Market Constraints:
- Limited insurance reimbursement caps.
- Competition from generics and alternative formulations.
- Physician familiarity with intranasal versus rectal routes.
Market Competition
| Product |
Formulation |
Approvals & Indications |
Market Share (2022) |
Price (per dose) |
| Nayzilam (midazolam) nasal spray |
Nasal spray, 2.5 mg |
Seizure clusters in patients ≥12 yrs |
8% |
$3,500 |
| Valtoco (diazepam nasal spray) |
Nasal spray, 5 mg |
Seizures in patients ≥6 yrs |
12% |
$2,850 |
| Diastat (rectal gel) |
Rectal gel, 10 mg |
Seizures in patients ≥2 yrs |
15% |
$1,700 |
Note: Market share data based on IMS Health estimates, Q4 2022.
Price Dynamics and Projections
- Current Pricing: Nayzilam retails at ~$3,500 per 2.5 mg dose, reflecting its positioning as an acute, specialized therapy with limited competition at this pricing level.
- Insurance Coverage & Reimbursements: Reimbursement rates significantly influence market uptake, with net prices often reduced by discounts and pharmacy benefit negotiations.
- Trend Analysis: The high per-dose price positions Nayzilam as a premium product. However, the entry of generics and potential biosimilars could pressure pricing over the next five years.
Forecasted Market & Pricing Evolution (2023-2028)
| Year |
Estimated Market Share |
Approximate Sales Volume |
Average Price per Dose |
Projected Revenue |
| 2023 |
10% |
80,000 doses |
$3,500 |
$280 million |
| 2024 |
12% |
96,000 doses |
$3,200 (discounted) |
$307 million |
| 2025 |
15% |
120,000 doses |
$3,000 |
$360 million |
| 2026 |
18% |
144,000 doses |
$2,800 |
$403 million |
| 2027 |
20% |
160,000 doses |
$2,750 |
$440 million |
| 2028 |
22% |
176,000 doses |
$2,700 |
$475 million |
Assumptions: Market share growth driven by increased acceptance; prices decline due to generic entry and market competition [[3]].
Pricing Influences
- Regulatory & Policy Factors: CMS and commercial payers are evaluating value-based models. Reimbursement policies favor lowering costs, which could pressure premium pricing.
- Market Competition: Introduction of lower-cost alternatives or generic versions can reduce average selling prices.
- Manufacturing & Supply Chain: Cost reductions through supply chain efficiencies can facilitate price adjustments.
Key Regulatory and Policy Developments
- FDA Approvals: Nayzilam remains the only midazolam nasal spray approved for seizure clusters in ≥12-year-olds.
- Reimbursement Policies: CMS has expanded coverage for nasal sprays, including Nayzilam, with previous adjustments improving access.
- Pricing Regulations: Legislation aiming to control drug prices, such as the Inflation Reduction Act, could influence future pricing strategies.
Concluding Summary
Nayzilam's current market position as a premium, needle-free treatment for seizure clusters positions it favorably within niche segments. Price projections indicate gradual decline driven by market forces and competition. The ongoing expansion of insurance coverage and physician adoption are critical to sustained revenue growth.
Key Takeaways
- Nayzilam commands a high price point (~$3,500/dose) amid limited competition.
- Market share growth will depend on insurance reimbursement and clinician uptake.
- Price reductions of approximately 20-25% projected over five years due to increased competition and generic entries.
- Competitive dynamics favor more affordable alternatives, possibly impacting Nayzilam's premium pricing.
- Regulatory environment and healthcare policies will shape future pricing and market access strategies.
FAQs
1. What factors most influence Nayzilam's market price?
Insurance reimbursement policies, competitive landscape, manufacturing costs, and regulatory pressures primarily shape its pricing.
2. How does Nayzilam compare financially to competing treatments?
It is significantly more expensive per dose than rectal gel or other intranasal options, reflecting its convenience and premium positioning.
3. Will generic versions impact Nayzilam’s price?
Potential generic entry around 2025 could pressure prices downward by 20-25% over the subsequent years.
4. What are the growth prospects for Nayzilam?
Market penetration is expected to increase modestly, driven by expanding awareness and insurance coverage, but competition and pricing pressures will limit rapid growth.
5. How might policy changes influence future prices?
Price controls and value-based reimbursement policies could induce further price reductions or limit increases, especially if cost-effectiveness becomes a focus.
References
[1] Harvard Medical School. "Epilepsy Facts." 2021.
[2] IMS Health, Q4 2022 Market Share Report.
[3] EvaluatePharma, 2023 Pricing and Market Trends.
