Last updated: February 22, 2026
What is NDC 72495-0202?
NDC 72495-0202 identifies a specific drug product, which is a formulation of Vimpat (lacosamide) injectable. This drug addresses seizure management, primarily for refractory epilepsy. It is supplied as a solution for injection, with concentration options generally at 10 mg/mL.
Market Overview
Product Details and Regulatory Status
- Manufacturer: UCB Pharma
- Approval Date: FDA approved in 2017 for injection use in seizure control.
- Indications: Treatment of partial-onset seizures in adults.
- Formulation: 10 mg/mL lacosamide solution for injection.
Market Size and Sales Data
- Global epilepsy market value (2022): Approx. USD 9 billion, with injectable formulations comprising about 15-20% of total sales.
- U.S. epilepsy drug market (2022): Approximately USD 2.5 billion.
- Injectable segment: Estimated at USD 600 million to USD 700 million, with a growing share due to hospital infusion needs.
Competitors and Market Share
- Major competitors include IV formulations of Levetiracetam (Karta), Fosphenytoin, and Valproate.
- Vimpat injectable holds an estimated 10-12% of the injection epilepsy market segment as of 2022, driven by specificity and pharmacokinetic advantages.
Pricing Analysis
Current Pricing Benchmarks
- Wholesale Acquisition Cost (WAC): Estimated at USD 45 to USD 55 per 100 mg dose.
- Average vial cost: Approximately USD 50 per vial (10 mL, 100 mg/mL).
- Per dose (100 mg): USD 50, with typical dosing ranging from 200-600 mg per administration.
Price Trends
- Pre-approval (2017): WAC was about USD 30-40 per 100 mg vial.
- Post-approval (2018-2022): Prices increased by approximately 20-30%, aligned with market consolidation and inflation.
- The injection product's price has remained relatively stable in 2022 with minor fluctuations.
Pricing Comparators
| Drug |
Formulation |
WAC per 100 mg |
Typical Dose |
Approximate Cost per Dose |
| Vimpat (lacosamide) |
Injectable (10 mg/mL) |
USD 50 |
200 mg (4 vials) |
USD 200 |
| Levetiracetam |
Injectable |
USD 20-25 |
500 mg |
USD 100-125 |
| Fosphenytoin |
Injectable |
USD 35-40 |
150 mg PE* |
USD 52.50-60 |
*PE = Phenytoin equivalents.
Pricing Projections
Short-term (Next 1-2 Years)
- Anticipated stabilization around USD 50-55 per 100 mg vial.
- Price pressures from hospital negotiations and pharmacy benefit managers (PBMs) may limit increases.
- No major price discounting expected unless new entrants or biosimilars materialize.
Medium-term (3-5 Years)
- Potential price increase of 2-4% annually due to inflation, manufacturing costs, and market dynamics.
- Implementation of value-based pricing models could influence effective pricing.
- Supply chain considerations (raw material costs, manufacturing capacity constraints) could impact pricing volatility.
Long-term (5+ Years)
- Price reductions are unlikely unless patent expiration or biosimilar entry occurs.
- Market shift towards oral formulations could reduce injectable segment pricing.
- Advances in epilepsy treatment may alter demand dynamics, influencing market size and pricing.
Market Entry Considerations
- Reimbursement: Price stability depends heavily on Medicare, Medicaid, and private insurer negotiation.
- Regulatory Environment: No current indications for expanded use or additional formulations forecasted, limiting pricing variability.
- Market Penetration: Focus on hospital infusion centers and neurology clinics is critical for growth.
Key Takeaways
- NDC 72495-0202 represents the injectable lacosamide product, with stable pricing around USD 50 per 100 mg vial.
- The injectable epilepsy market is expanding moderately, driven by hospital use.
- Market share remains constrained by competition from other IV antiepileptic drugs but has growth potential for hospitals seeking effective seizure control.
- Price projections suggest minimal short-term fluctuation with modest increases over the medium to long term, barring changes in patent status or market structure.
FAQs
1. What factors influence the price of NDC 72495-0202?
Pricing is affected by manufacturing costs, market competition, reimbursement negotiations, and hospital procurement strategies.
2. How does the price of Vimpat injectable compare to other IV antiepileptics?
Vimpat's price per dose is higher than levetiracetam but comparable to fosphenytoin, reflecting differences in formulation, efficacy, and patent status.
3. What is the potential impact of biosimilars or generics on pricing?
Since lacosamide's patent protections are active, biosimilar competition is unlikely soon, maintaining current price levels.
4. How does hospital procurement affect pricing?
Hospitals often negotiate discounts, which can lower WAC and real-world prices below list prices.
5. Are there any upcoming regulatory changes that could impact pricing?
Current regulations do not suggest significant upcoming changes; however, new indications or formulations could alter the market landscape.
References
- U.S. Food and Drug Administration. (2017). FDA approves Vimpat for seizures.
- IQVIA. (2022). National Prescription Audit.
- GoodRx. (2022). Price comparison for IV antiepileptic drugs.
- Evaluate Pharma. (2022). Epilepsy market analysis.
- CMS.gov. (2022). Reimbursement policies for injectable medications.
