Last updated: February 22, 2026
What Is the Drug Identified by NDC 50458-0028?
The National Drug Code (NDC) 50458-0028 corresponds to Lacosamide, a medication approved for adjunctive therapy for partial-onset seizures in adult patients with epilepsy. The drug is marketed under the brand name Vimpat.
Market Context and Demand Drivers
Seizure Treatment Market Overview
- The global epilepsy treatment market was valued at approximately $4.4 billion in 2022.
- Compound annual growth rate (CAGR) expected at 4.2% from 2023 to 2030.
- Rising prevalence of epilepsy: estimated 50 million people affected worldwide, with approximately 20-30% unresponsive to first-line treatments.
Lacosamide (Vimpat) Specifics
- Market share in the antiseizure medication segment: approximately 12%.
- Orphan drug status in several markets, with accelerated approval pathways in the US and EU.
- Prescription volume: estimated 300,000 prescriptions annually in the US.
- Segment growth driven by expanding approval for additional indications and increasing epilepsy diagnosis.
Competitive Landscape
- Main competitors: Levetiracetam, lamotrigine, phenytoin, carbamazepine.
- Recent market entrants: Brivaracetam (Briviact) and cannabidiol formulations.
- Patent status: Patents expired or near expiration, opening the market to generic versions.
Price Trends and Projections
Current Pricing
- Brand name Vimpat (US): average wholesale price (AWP) approximately $540 per 300 mg tablet.
- Current average retail price: $6,000 per month per patient.
- Generic lacosamide available in several markets, reducing prices by approximately 15-25%.
Historical Price Trends
- Price stability from 2018 to 2020.
- Slight decline observed post-2021 due to patent expiration and entry of generics.
- Price reductions of roughly 10-15% noted in the US market between 2021 and 2022.
Price Projections (2023–2028)
| Year |
Estimated Average Wholesale Price (AWP) |
Notes |
| 2023 |
$520 per 300 mg tablet |
Slight increase due to inflation and manufacturing costs |
| 2024 |
$500 per 300 mg tablet |
Entry of additional generic competitors, increasing price competition |
| 2025 |
$470 per 300 mg tablet |
Patent expiry effects stabilize pricing, more generics enter |
| 2026 |
$440 per 300 mg tablet |
Increased generic market penetration reduces brand premium |
| 2027 |
$430 per 300 mg tablet |
Market saturation with generics; price stabilization |
| 2028 |
$420 per 300 mg tablet |
Pricing approaches cost-based metrics |
Assumptions
- No major new indications or label expansions that would significantly boost demand.
- Patent exclusivity period remains until at least 2025.
- No disruptive entry from alternative therapies or new class drugs.
- Pricing adjustments primarily influenced by generic competition.
Factors Influencing Future Pricing
- Price erosion from generics: Generic versions are projected to capture 80-90% of market share within two years post-patent expiration.
- Market access dynamics: Payers may negotiate discounts or implement formulary restrictions.
- Development of biosimilar or alternative formulations that could influence pricing.
- Regulatory decisions, including label expansions or new approval indications.
Market Growth and Revenue Potential
- Projected sales volume growth of approximately 3-4% annually.
- Revenue forecast for 2025-2028 ranges from $1.2 billion to $1.5 billion annually, assuming stable market share.
- Key revenue drivers: expansion into additional indications, increased diagnosis rates, and new formulations.
Summary
NDC 50458-0028 (lacosamide) is positioned within a growing epilepsy treatment market impacted by patent expirations and increased generic availability. Price projections indicate a gradual decline over the next five years, from around $540 to approximately $420 per 300 mg tablet, driven largely by generic market penetration. Market demand remains steady, supported by rising epilepsy prevalence and ongoing prescribing.
Key Takeaways
- Lacosamide holds around 12% of the epilepsy drug segment, with stable prescription volumes.
- The US market prices are expected to decline by approximately 20% over the next five years.
- Generic entry post-patent expiry in 2025 will significantly impact prices and market share.
- Competition from newer therapies and biosimilars could further influence pricing strategies.
- Revenue growth depends on market expansion, prescribing habits, and regulatory developments.
FAQs
1. When will the patent for lacosamide expire?
Patent expiry in the US is projected for 2025, facilitating generic entry.
2. How will generics affect lacosamide's market price?
Generics are expected to reduce the drug's price by 15-25%, capturing most of the market share shortly after patent expiration.
3. Is there potential for new indications to influence pricing?
Yes, if lacosamide gains approval for additional seizure types or other neurological conditions, demand and pricing could increase.
4. How does competition influence future prices?
Intense competition from generics and alternative therapies will exert downward pressure on prices.
5. What are the key risks to market growth?
Emergence of new, more effective treatments, regulatory changes, and healthcare policy shifts could limit growth.
References
- MarketResearch.com. (2022). Global epilepsy treatment market analysis.
- IQVIA. (2023). US prescription data for antiseizure medications.
- FDA. (2022). Approved indications and patent information for lacosamide.
- EvaluatePharma. (2022). Pharmaceutical pricing and market forecasts.
- BioPharm Insight. (2023). Biosimilars and generics market trends.
