Last updated: February 21, 2026
What is the drug associated with NDC 00169-4130?
NDC 00169-4130 is associated with Vimpat (lacosamide). It is a prescription medication used as adjunctive therapy for partial-onset seizures in adults. Lacosamide enhances slow inactivation of voltage-gated sodium channels, stabilizing hyperexcitable neuronal membranes.
Market Overview
Current Market Size and Growth
The global epilepsy and seizure management market was valued at approximately $5.0 billion in 2022. An increasing prevalence of epilepsy, estimated at about 50 million worldwide, drives demand. The U.S. accounts for roughly 30% of the global market.
The laser focus on new-generation antiepileptics like lacosamide reflects the shifting emphasis away from traditional medications such as carbamazepine.
Competitive Landscape
Vimpat faces competition from entrenched drugs like:
- Levetiracetam (Keppra)
- Lamotrigine (Lamictal)
- Topiramate (Topamax)
In 2022, Vimpat’s U.S. sales reached approximately $600 million, making it a significant player in the adjunctive treatment segment.
Patent and Patent Expiry
Vimpat’s primary patents expired or are nearing expiration. A notable patent for crystalline forms expires in 2027, with some formulations lingering due to secondary patents expiring later. This opens the market for generics post-2027.
Regulatory Status
Vimpat has full FDA approval, including in pediatric populations. Label expansions for indications like diabetic nerve pain are under consideration but not yet approved.
Pricing Trends
Current Pricing (U.S. Market)
- Brand-name (Vimpat): Approximate retail price per 60 mg tablet ranges from $10 to $15.
- Generic lacosamide: Prices typically range from $2 to $5 per 50 mg tablet**, depending on supplier and pharmacy.
Reimbursement Environment
Insurance coverage remains favorable for Vimpat due to established formulary placement in seizure management. However, increasing generic penetration may pressure prices downward.
Cost-Effectiveness
Studies indicate Vimpat’s cost per quality-adjusted life-year (QALY) exceeds $50,000, a common threshold for treatment value, which influences formulary decisions and pricing negotiations.
Price Projection Scenarios
Short-Term (Next 2 Years)
- Price stability: Given patent protection, retail prices for Vimpat are expected to stay roughly constant.
- Generics entry: Post-2027, generic lacosamide could decrease prices by 60-80%, leading to a significant reduction in brand-name sales and a shift in prescribing patterns toward generics.
Medium to Long-Term (3–5 Years)
- Post-patent expiration: Average prices for lacosamide generics are projected to decrease to roughly $1–$2 per 50 mg tablet.
- Market share shifts: While Vimpat may retain some market share through brand loyalty and formulary preferences, generics will dominate.
Market Dynamics Influencing Prices
- Pricing negotiations: Payers and pharmacy benefit managers (PBMs) will push for lower prices to contain costs.
- Manufacturers' strategies: Brand manufacturers may introduce combination formulations or extended-release versions to sustain profitability.
- Regulatory developments: Any new indications or revised labeling could temporarily stabilize or boost prices.
Summary of Future Market Metrics
| Year |
Average Price of Brand Vimpat |
Approximate Price of Generics |
Key Market Drivers |
| 2023 |
$12 per 60 mg tablet |
$4 per 50 mg tablet |
Patent exclusivity, insurance coverage |
| 2025 |
$12 (continued stability) |
$3.50-$4 |
Patent nearing expiration |
| 2027 |
Patent expiry; generics enter |
$1–$2 |
Increased generic penetration |
| 2028+ |
– |
<$2 |
Market saturation, cost pressure |
Key Takeaways
- Vimpat (lacosaamide) held resilient sales of approximately $600 million in 2022, driven by efficacy and brand loyalty.
- Patent expirations starting in 2027 will precipitate a sharp decline in prices, with generics expected to exert downward pressure starting the same year.
- Brand prices are likely to remain stable until patent loss; thereafter, prices for generic lacosamide are projected to fall by over 80%.
- Market share may shift toward generics post-patent, impacting revenue streams for the brand.
- Regulatory pathways and formulary negotiations will influence long-term pricing and access strategies.
FAQs
1. When will generic lacosamide enter the market?
Post-2027, following patent expiration for primary formulations.
2. What factors could influence the price trajectory?
Patent litigation, regulatory changes, payer negotiations, and new formulation development.
3. How does lacosamide compare to other antiepileptics in cost?
It is more expensive than older drugs but provides superior tolerability and efficacy, influencing formulary placement.
4. What is the potential for combination therapies involving lacosamide?
Limited current data; regulatory approval for combination therapies is required, which could impact pricing.
5. Are there any approved biosimilars or biosimilar-like alternatives?
No biosimilars exist; lacosamide is a small-molecule drug with generic versions expected after patent expiry.
Sources
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2022). Vimpat (lacosamide) FDA Approval Status.
[3] Evaluate Pharma. (2023). Global Epilepsy Drugs Market Forecast.
[4] GoodRx. (2023). Drug Pricing Data.
[5] Statista. (2022). Prescription Medication Trends.
