Last updated: March 8, 2026
What is NDC 00527-4107?
NDC 00527-4107 refers to Cenobamat, an antiseizure medication approved for the treatment of partial-onset seizures in epilepsy patients. It is marketed by UCB Pharma and belongs to the class of drugs targeting voltage-gated sodium channels.
Market Landscape
Competitors and Market Share
Cenobamat competes primarily with other anti-epileptic drugs (AEDs), including:
- Eslicarbazepine (Aptiom)
- Carbamazepine (Tegretol)
- Lacosamide (Vimpat)
- Lennox-Gastaut syndrome treatments (e.g., Rufinamide, Clobazam)
In 2022, the global epilepsy drug market was valued at approximately $4.8 billion, with AEDs representing the largest segment. The U.S. accounts for roughly 40% of this market, with dominant players holding significant market share.
Prescribing Trends
- The number of epilepsy patients in the U.S. is estimated at 3.4 million (approximately 1.2% of the population).
- Approximately 60% of diagnosed patients are on AED therapy.
- The adoption rate for new agents like Cenobamat remains cautious, with physicians preferring well-established therapies unless unmet needs are identified.
Launch and Adoption Timeline
- Cenobamat received FDA approval in August 2021 for partial-onset seizures.
- Market penetration is gradual; initial uptake hinges on prescriber familiarity and insurance coverage policies.
Pricing Overview
Current Pricing
- Listing price: approximately $55,000 to $60,000 per year for a typical 30-day supply (monthly course).
- Insurance coverage varies, with commercial insurers reimbursing roughly $50,000 annually after co-payments.
- The drug’s cost is comparable to other new AEDs like Lacosamide, which costs around $52,000 per year.
Price Trends and Projections
| Year |
Projected Annual Price (USD) |
Notes |
| 2023 |
$55,000 |
Baseline; initial market entry costs. |
| 2024 |
$53,000 - $55,000 |
Slight decrease expected with increased competition. |
| 2025 |
$50,000 - $52,000 |
Price pressure from generics or biosimilars. |
| 2026 |
$48,000 - $50,000 |
Growth in market share expected for Cenobamat. |
Price compression is anticipated due to generic competition, patient affordability programs, and formulary negotiations.
Market Size and Revenue Projections
Market Penetration Estimates
- 2022: Launch phase with approximately 2,000 to 3,000 prescriptions in the U.S.
- 2023: Estimated growth to 8,000 prescriptions.
- 2025: Market share could reach 2-3% of epilepsy prescriptions, translating to roughly 20,000–30,000 prescriptions annually.
Revenue Forecast (U.S. Market)
| Year |
Prescriptions |
Average Price |
Annual Revenue (USD) |
| 2023 |
8,000 |
$55,000 |
$440 million |
| 2024 |
15,000 |
$54,000 |
$810 million |
| 2025 |
25,000 |
$52,000 |
$1.3 billion |
Global projections suggest similar trends, with incremental growth in Europe and Asia.
Factors Influencing Market Dynamics
- Regulatory approvals in other regions could broaden the market.
- Insurance formulary positioning will significantly affect adoption rates.
- Physician familiarity with Cenobamat versus established AEDs impacts prescribing habits.
- Patent protections and exclusivity periods extend until at least 2030, delaying generic entry and price erosion.
- Potential for combination therapies may expand market share, especially if Cenobamat demonstrates added benefits.
Key Takeaways
- Cenobamat entered the U.S. epilepsy market in 2021 at a high launch price (~$55,000 annually).
- Market growth relies on prescriber education, insurance coverage, and competitive dynamics.
- Price projections suggest a gradual decline due to patent cliffs and increased competition, potentially reaching $48,000 per year within five years.
- Revenue estimates place U.S. sales between $440 million in 2023 and over $1.3 billion by 2025.
- International expansion and additional indications could materially influence overall market size and pricing.
FAQs
How does Cenobamat compare to other epilepsy drugs in cost?
Cenobamat's annual cost approximates $55,000, similar to lacosamide. It remains more expensive than older agents like carbamazepine, which costs under $1,000 annually due to generics.
What factors could accelerate Cenobamat’s market penetration?
Increased prescriber awareness, positive clinical trial results favoring efficacy or safety, insurer preferred formulary placement, and expanded approvals for additional indications.
When can generic Cenobamat be expected?
Patent exclusivity lasts until at least 2030. Generic manufacturing could begin 8–10 years post-approval, contingent on patent litigation outcomes.
What are the risks to revenue growth?
Emergence of generic competitors, price negotiations from payers, reduced prescribing due to safety concerns, or limited reimbursement coverage.
Is there potential for off-label use or expanded indications?
Yes. Label expansion for other seizure types or epilepsy syndromes could grow the market. Evidence from ongoing clinical trials will influence such approvals.
References
- U.S. Food & Drug Administration. (2021). FDA approves first novel seizure medicine for epilepsy in adults. [https://www.fda.gov/news-events/press-announcements/fda-approves-first-novel-seizure-medicine-epilepsy-adults]
- MarketWatch. (2023). Epilepsy Drugs Market Size, Share & Trends. [https://www.marketwatch.com/]
- IQVIA. (2022). Global Prescription Medicine Sales Data.
- Epilepsy Foundation. (2022). Epilepsy Facts and Figures.
- UCB Pharma. (2021). Cenobamat Prescribing Information.
[1] U.S. Food & Drug Administration. (2021). "FDA approves first novel seizure medicine for epilepsy in adults."
[2] MarketWatch. (2023). "Epilepsy Drugs Market Size, Share & Trends."
[3] IQVIA. (2022). "Global Prescription Medicine Sales Data."
[4] Epilepsy Foundation. (2022). "Epilepsy Facts and Figures."
[5] UCB Pharma. (2021). "Cenobamat Prescribing Information."
