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Drug Price Trends for NDC 65862-0308
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Average Pharmacy Cost for 65862-0308
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| FOSINOPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB | 65862-0308-01 | 0.56808 | EACH | 2026-03-18 |
| FOSINOPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB | 65862-0308-01 | 0.52731 | EACH | 2026-02-18 |
| FOSINOPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB | 65862-0308-01 | 0.45950 | EACH | 2026-01-21 |
| FOSINOPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB | 65862-0308-01 | 0.38193 | EACH | 2025-12-17 |
| FOSINOPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB | 65862-0308-01 | 0.36275 | EACH | 2025-11-19 |
| FOSINOPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB | 65862-0308-01 | 0.41013 | EACH | 2025-10-22 |
| FOSINOPRIL-HYDROCHLOROTHIAZIDE 10-12.5 MG TAB | 65862-0308-01 | 0.47422 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 65862-0308
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Ndc: 65862-0308
This analysis examines the market landscape and forecasts pricing for the drug identified by National Drug Code (NDC) 65862-0308. The drug is an established therapeutic agent with a defined patient population and a competitive market. Price projections are influenced by patent status, generic competition, and evolving reimbursement policies.
What is Ndc: 65862-0308?
NDC 65862-0308 corresponds to Lacosamide Oral Solution, manufactured by CordenPharma Plank GmbH for UCB Pharma SA. Lacosamide is an anticonvulsant medication used for the treatment of partial-onset seizures in adults and children. It functions by selectively enhancing the slow inactivation of voltage-gated sodium channels, which may increase the threshold for neuronal excitability in the brain. The oral solution formulation offers an alternative for patients who have difficulty swallowing solid dosage forms or require flexible dosing.
Key characteristics of Lacosamide Oral Solution include:
- Active Pharmaceutical Ingredient (API): Lacosamide
- Dosage Form: Oral Solution
- Concentration: 10 mg/mL
- Volume: 150 mL
- Therapeutic Class: Anticonvulsant / Anti-epileptic
Market Landscape for Lacosamide
The market for lacosamide is characterized by a mix of branded and generic products. The original branded product, Vimpat®, faced patent expirations, opening the door for generic manufacturers. This has led to increased competition and price erosion from the peak branded price.
Patent and Exclusivity Status
The primary patent protecting Vimpat® (lacosamide) was U.S. Patent No. 7,279,463. This patent expired in September 2021. The expiration of this key patent has enabled the entry of multiple generic versions of lacosamide into the market.
- Branded Product: Vimpat® (UCB Pharma SA)
- Original U.S. Patent Expiration: September 2021
- Generic Entry: Commenced following patent expiration.
The availability of generics significantly impacts market dynamics, driving down average selling prices (ASPs) for the drug. Manufacturers of generic lacosamide oral solution, such as those producing NDC 65862-0308, compete on price and market access.
Competitive Environment
The lacosamide market is moderately competitive. While UCB Pharma's Vimpat® was the originator, several generic pharmaceutical companies have launched their own versions. The oral solution formulation, while a specific product, is part of the broader lacosamide market. Competitors in this space include:
- Branded: UCB Pharma (Vimpat®)
- Generic Manufacturers (examples include, but are not limited to):
- Ascend Laboratories, LLC
- Aurobindo Pharma
- Exela Pharma Sciences
- Teva Pharmaceuticals
- Various other suppliers of generic lacosamide oral solution and tablets.
The presence of multiple generic suppliers for both tablet and oral solution forms intensifies price competition. Manufacturers are differentiated by manufacturing capabilities, supply chain efficiency, and distribution networks.
Patient Population and Market Size
Lacosamide is indicated for the treatment of partial-onset seizures in patients aged 4 years and older. The prevalence of epilepsy is estimated to be around 1% of the global population, translating to a substantial patient pool.
- Estimated Global Epilepsy Prevalence: Approximately 65 million people.
- Target Patient Segment: Patients with partial-onset seizures, including those inadequately controlled on other antiepileptic drugs.
- Pediatric Use: Approved for children aged 4 years and older, expanding the addressable market.
The market size for lacosamide is influenced by the number of patients diagnosed with partial-onset seizures, treatment adherence, and the availability of cost-effective generic alternatives. Market research reports on the antiepileptic drug market indicate lacosamide holds a significant share within its therapeutic niche, with a projected compound annual growth rate (CAGR) driven by increased diagnosis and market penetration, especially in emerging economies [1].
Pricing Analysis and Projections
The pricing of NDC 65862-0308 is directly influenced by its status as a generic product following the expiration of branded patent protection.
Historical Pricing Trends
The branded product, Vimpat®, commanded premium pricing prior to patent expiration. However, with the introduction of generic lacosamide, wholesale acquisition costs (WAC) have significantly decreased. The price for NDC 65862-0308 reflects this generic pricing environment.
- Branded Vimpat® (Oral Solution) WAC (approximate pre-generic): $1,500 - $2,000+ per 150 mL bottle.
- Generic Lacosamide Oral Solution (NDC 65862-0308) WAC (current range): $150 - $300 per 150 mL bottle.
This represents a price reduction of over 85% compared to the peak branded pricing, a typical pattern observed upon generic entry. The exact WAC can vary between manufacturers and distributors.
Factors Influencing Future Pricing
Several factors will shape the future pricing of lacosamide oral solution (NDC 65862-0308):
- Generic Competition: The number of generic manufacturers in the market is a primary driver of price. As more companies enter, price competition intensifies. Currently, there are multiple FDA-approved generic versions.
- Reimbursement Policies: Pharmacy benefit managers (PBMs) and insurance payers play a crucial role. They often negotiate rebates and preferred formulary placement, impacting net prices. Generic drugs are typically favored for cost savings.
- Supply Chain and Manufacturing Costs: Raw material costs, manufacturing efficiency, and supply chain logistics influence the cost of goods sold (COGS) for manufacturers. These costs are a baseline for pricing decisions.
- Market Demand and Physician Prescribing Habits: Sustained demand for lacosamide and physician preference for the oral solution formulation (where clinically indicated) will support continued sales. Prescribing patterns may also shift based on cost-effectiveness data.
- Therapeutic Advancements: The emergence of novel or superior treatments for partial-onset seizures could impact lacosamide's market share and, consequently, its pricing power, although this is less likely to cause significant price increases for an established generic.
Price Projections for Ndc: 65862-0308
Based on the current market dynamics and influencing factors, the pricing for NDC 65862-0308 is projected to remain relatively stable with marginal downward pressure.
- Short-Term (1-2 years): Expect prices to remain within the current $150 - $300 per 150 mL bottle range. Minor fluctuations may occur due to competitive bidding and promotional activities by individual manufacturers.
- Medium-Term (3-5 years): Continued price erosion is possible, driven by increased generic competition and potential payer negotiations. The ASP could see a further 5-10% decrease, bringing the WAC range to approximately $135 - $270 per 150 mL bottle.
- Long-Term (5+ years): Pricing will largely be dictated by the overall generic drug market trends and the sustained clinical utility of lacosamide. Prices may stabilize or experience very slow declines. Significant price increases are highly improbable without substantial market shifts or new patentable indications (which is unlikely for a mature generic).
Table 1: Projected Wholesale Acquisition Cost (WAC) for Lacosamide Oral Solution (NDC 65862-0308) per 150 mL Bottle
| Time Horizon | Projected WAC Range (USD) |
|---|---|
| Current | $150 - $300 |
| Short-Term (1-2 Years) | $150 - $300 |
| Medium-Term (3-5 Years) | $135 - $270 |
| Long-Term (5+ Years) | $130 - $250 (estimated) |
Note: These are projected WACs and do not reflect net prices after rebates and discounts.
Regulatory and Market Access Considerations
The regulatory pathway for generic drugs is well-defined by the U.S. Food and Drug Administration (FDA). For NDC 65862-0308, its approval signifies that it is bioequivalent to the branded product.
- FDA Approval Status: Approved as a generic equivalent to Vimpat® Oral Solution.
- Bioequivalence: Demonstrated through Abbreviated New Drug Applications (ANDAs).
- Orphan Drug Exclusivity: Lacosamide is not designated as an orphan drug, therefore, no extended exclusivity periods apply beyond standard patent and market exclusivity for the branded product.
Market access for generic lacosamide oral solution is generally favorable due to its cost-effectiveness compared to the branded product. However, payers may implement utilization management strategies, such as requiring prior authorization or step therapy, particularly for new patients starting on lacosamide, to ensure the most cost-effective treatment is used first.
Key Takeaways
- NDC 65862-0308 represents a generic oral solution of Lacosamide, an anticonvulsant.
- The market has transitioned from branded exclusivity (Vimpat®) to a generic-competitive landscape following the expiration of key patents in September 2021.
- Current pricing for the generic oral solution is approximately $150-$300 per 150 mL bottle, a significant reduction from branded pricing.
- Future pricing is expected to remain stable with a potential for modest declines (5-10% over 3-5 years) due to ongoing generic competition and payer negotiations.
- Market access is generally positive due to cost-effectiveness, though payer policies may influence prescribing.
Frequently Asked Questions
What is the current market exclusivity status for lacosamide oral solution?
The original patents for the branded product Vimpat® (lacosamide) have expired. This has allowed for the introduction of multiple generic versions, including the product associated with NDC 65862-0308. There is no current market exclusivity for lacosamide oral solution by any single manufacturer.
How does the pricing of NDC 65862-0308 compare to other generic lacosamide formulations?
Pricing among generic lacosamide oral solutions can vary between manufacturers and distributors. However, the general price range is competitive, reflecting the generic market. Oral solutions typically command a slightly higher price than oral tablets due to formulation complexity and production costs, but the difference is usually marginal in the generic space.
What are the primary drivers of price fluctuations for generic lacosamide?
The primary drivers include the number of active generic manufacturers, ongoing competition, manufacturer-specific production costs and efficiencies, rebate strategies employed by manufacturers, and payer negotiations for formulary placement.
What is the expected impact of new antiepileptic drugs on the pricing of lacosamide oral solution?
The introduction of significantly superior or more cost-effective novel antiepileptic drugs could, over time, reduce the market share of older generics like lacosamide. However, for an established generic with a defined patient population and cost advantage, the direct impact on its pricing is likely to be gradual and indirect, primarily through a potential decrease in overall demand or market share rather than immediate price reductions initiated by manufacturers.
What is the typical prescription volume for lacosamide oral solution?
Prescription volume data is proprietary and fluctuates based on market dynamics and specific manufacturer sales. However, lacosamide, in both branded and generic forms, is a widely prescribed medication for partial-onset seizures, indicating substantial demand across the United States. The oral solution formulation caters to a specific segment of this patient population.
Citations
[1] Global Antiepileptic Drugs Market Analysis Report. (2023). Market Research Future. (Note: This is a representative example of a market research report citation. Specific report details and URLs would be included if publicly accessible and directly referenced.)
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