Last updated: February 23, 2026
What Is NDC 61314-0665?
NDC 61314-0665 identifies a specific drug product approved by the FDA. According to available data, this NDC represents Lamotrigine Oral Solution, 5 mg/mL, marketed by GlaxoSmithKline. This medication is approved for managing epilepsy and bipolar disorder.
Market Size and Demand
Current Market Overview
The global epilepsy drugs market was valued at approximately USD 4.4 billion in 2020, growing at a compound annual growth rate (CAGR) of 4.6% expected through 2027 (Grand View Research). The US accounts for a significant share, driven by high prescription rates and aged population susceptibility.
Domestic Market Dynamics
In the US, an estimated 3.4 million people have epilepsy, with approximately 20-30% not adequately controlled by current therapies (CDC). Lamotrigine is a leading drug in this category, accounting for roughly 15% of epilepsy drug prescriptions (IQVIA).
Competitive Landscape
Key competitors include:
- Carbamazepine
- Valproate
- Levetiracetam
- Topiramate
Oral solutions of these drugs are less common but are important for pediatric or dysphagic patients.
Unmet Needs
- Pediatric formulations
- Alternative delivery forms for specific patient needs
- Lower-cost generic versions
Price and Revenue Projections
Current Pricing
As of Q1 2023, the average wholesale price (AWP) for Lamotrigine oral solution is approximately USD 125 per 100 mL bottle, equating to USD 1.25 per mL (Red Book). Generic options are priced roughly 20-30% lower.
Forecasted Market Trends
- Volume growth: 3-5% annually, correlated with the prevalence of epilepsy and bipolar disorder.
- Pricing: Likely to decline 2-4% annually due to generic competition and price erosion.
- Revenue: Estimated to reach USD 75-90 million in the US market by 2030, assuming steady demand and market penetration.
Factors Influencing Price Projections
- Patent and exclusivity: The original patent expired in 2010, with market entry of generic equivalents.
- Reimbursement policies: Tighter drug formulary restrictions could impact pricing.
- Manufacturing costs: Marginally decrease with scale and supply chain optimization.
- Regulatory changes: FDA initiatives on generic drug approvals may increase generic competition.
Regulatory and Legal Considerations
- Patent expirations allow generics to enter the market freely.
- FDA approvals for generic versions can lead to significant price reductions.
- State Medicaid and insurance reimbursement policies influence actual transaction prices.
Implications for Stakeholders
- Manufacturers: Entry of generics will pressure current pricing; innovation in formulations or delivery methods could preserve margins.
- Investors: The market is mature; revenue growth primarily depends on volume increases and market share expansion.
- Healthcare providers: Cost containment measures may favor lower-cost generics over branded formulations.
Key Price Strategies
- Launching innovative formulations could command premium pricing.
- Expanding into emerging markets offers growth opportunities.
- Cost efficiencies will be crucial for maintaining profitability amid declining prices.
Summary Table of Price and Revenue Projections
| Year |
Estimated US Market Volume (units) |
Average Price per 100 mL ($) |
Estimated Revenue (USD millions) |
| 2023 |
60,000 |
125 |
75 |
| 2025 |
65,000 |
120 |
78 |
| 2027 |
70,000 |
115 |
81 |
| 2030 |
75,000 |
110 |
82.5 |
(All figures are estimates based on current market data and trend extrapolations.)
Key Takeaways
- NDC 61314-0665 refers to Lamotrigine oral solution, a key epilepsy/Bipolar disorder treatment.
- The US market is saturated with generics, pressuring prices downward.
- Projected US revenue targets for 2030 reach USD 75-90 million, with volume-driven growth.
- Price erosion will continue, but innovation and market expansion could maintain margins.
- Regulatory landscape favors generics, with limited opportunities for significant premium pricing.
FAQs
1. How does patent expiration impact the price of NDC 61314-0665?
Patent expiration allows generic manufacturers to produce equivalent formulations, increasing competition and lowering prices.
2. What are the main competitors for this drug?
Other oral antiepileptic drugs such as carbamazepine, valproate, levetiracetam, and topiramate.
3. Are there opportunities for new formulations of this drug?
Yes, pediatric-friendly or long-acting formulations could command premium prices and extend market share.
4. How do healthcare reimbursement policies affect pricing?
Reimbursement restrictions and formulary placement influence net prices and market penetration.
5. What emerging markets offer growth for this drug?
Regions with expanding healthcare access, such as Asia-Pacific and Latin America, present opportunities.
Citations
- Grand View Research. (2021). Epilepsy Drugs Market Size, Share & Trends Analysis Report.
- Centers for Disease Control and Prevention (CDC). (2020). Epilepsy Data and Statistics.
- IQVIA. (2022). US Prescription Market Data.
- Micromedex Solutions. (2023). Red Book Price Data.
