Last updated: February 17, 2026
Overview of NDC 51672-1263
NDC code 51672-1263 specifies the drug Cenobamate (brand name: Xcopri). Approved by the FDA in 2019, Cenobamate is indicated for the management of partial-onset seizures in adults with epilepsy. It is marketed by Aquestive Therapeutics.
Market Landscape
1. Market Demand and Patient Population
Approximately 3.4 million Americans live with epilepsy, with about 40% suffering from focal seizures. The U.S. market for epilepsy drugs exceeds $1 billion annually, with newer agents capturing increasing market share due to improved efficacy and safety profiles.
Cenobamate's target population is estimated at 1.2 million adults with focal epilepsy in the U.S., considering the prevalence and existing treatment gaps. The drug's potential is reinforced by its rapid onset of action and minimal drug interactions, prompting prescriber interest.
2. Competitive Position
Cenobamate competes primarily with drugs such as lamotrigine, levetiracetam, carbamazepine, and lacosamide. Its distinctive profile includes high efficacy and lower dosing frequency, which may influence prescriber preference.
Market penetration is projected to grow as clinicians become more familiar with its benefits and as additional real-world evidence accumulates.
3. Regulatory and Commercial Factors
Reimbursement avenues are under development, with initial coverage becoming available through major payers. FDA approval and support from epilepsy advocacy groups enhance adoption prospects.
Pricing strategies and formulary placements are vital. As of early 2023, Cenobamate's wholesale acquisition cost (WAC) is approximately $660 per month, translating to roughly $7,920 annually per patient (based on 12-month therapy).
Price Projections and Revenue Estimates
| Year |
Estimated Market Penetration |
Total Patients (U.S.) |
Annual Revenue (USD) |
Remarks |
| 2023 |
10% |
120,000 |
$960 million |
Launch phase, limited prescriber uptake |
| 2024 |
15% |
180,000 |
$1.42 billion |
Increased prescriber familiarity, formulary access |
| 2025 |
25% |
300,000 |
$2.37 billion |
Broader access, insurance coverage improved |
| 2026 |
35% |
420,000 |
$3.32 billion |
Growing clinician confidence and patient adoption |
Factors influencing price and revenue growth include:
- Payer negotiation strength
- Competition from alternative treatments
- Label updates or expanded indications
- Price adjustments for affordability and access
Long-Term Price Trends
Prices for novel epilepsy drugs tend to stabilize after initial premiums, with gradual decreases driven by biosimilar or generic entry, although generics are unlikely for Cenobamate due to patent protections.
Assuming price adjustments of 3% annually, future WAC prices may decline to approximately $580 per month (~$6,960 annually) by 2026, depending on market dynamics.
Regulatory and Policy Impacts
The U.S. Medicare Part D and commercial insurance policies favor cost-effective therapies. Price controls and value-based purchasing models could influence future pricing, especially if Cenobamate demonstrates superior efficacy or safety.
Summary of Key Insights
- The U.S. epilepsy market exceeds $1 billion annually.
- Cenobamate’s estimated peak sales could reach over $3 billion by 2026.
- The initial wholesale price (~$660/month) is competitive but may decrease as patents mature.
- Market penetration hinges on prescriber acceptance, payer coverage, and real-world evidence.
Key Takeaways
Cenobamate (NDC 51672-1263) is positioned as a high-efficacy option for focal epilepsy. Its revenue outlook depends on adoption speed, competitive forces, and reimbursement policies. Its initial pricing supports robust margins, with potential for moderate downward adjustments over time.
Frequently Asked Questions
Q1: What is the current patent status of Cenobamate?
Cenobamate’s primary patents extend into the mid-2030s, protecting exclusivity and preventing generic competition until then [1].
Q2: How does Cenobamate compare price-wise to other epilepsy drugs?
Its wholesale cost (~$660/month) is comparable to other branded agents like lacosamide (~$600/month). Its value proposition emphasizes efficacy and safety benefits.
Q3: What are the main barriers to market expansion?
Barriers include prescriber familiarity, insurance formulary restrictions, and competition from established therapies. Extended clinical data and favorable reimbursement will be critical.
Q4: Are there plans for expanded indications?
FDA approval updates or additional indications could enlarge market scope but are not confirmed as of early 2023.
Q5: How might biosimilars or generics impact pricing?
Given patent protections, biosimilar entry is unlikely before patent expiration. Generic versions may emerge afterward, potentially reducing prices by up to 80%.
Sources
[1] FDA Drug Approval Package for Xcopri (Cenobamate), 2019.
[2] IQVIA National Prescription Audit, 2022.
[3] EvaluatePharma, 2023.
[4] Centers for Medicare & Medicaid Services, 2023.
