Drug Price Trends for NDC 50268-0789

Average Pharmacy Cost for 50268-0789

Drug Name	NDC	Price/Unit ($)	Unit	Date
VALACYCLOVIR HCL 1 GRAM TABLET	50268-0789-15	0.40550	EACH	2026-03-18
VALACYCLOVIR HCL 1 GRAM TABLET	50268-0789-11	0.40550	EACH	2026-03-18
VALACYCLOVIR HCL 1 GRAM TABLET	50268-0789-15	0.40668	EACH	2026-02-18

Best Wholesale Price for NDC 50268-0789

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

U.S. Market Analysis and Price Projections for NDC: 50268-0789 (Lacosamide)

Last updated: February 17, 2026

This report analyzes the U.S. market for lacosamide (NDC: 50268-0789), a medication used to treat partial-onset seizures. It examines current market dynamics, patent landscape, and provides price projections.

What is the U.S. Market Size and Growth Trajectory for Lacosamide?

The U.S. market for lacosamide, identified by NDC 50268-0789, is substantial, driven by its established efficacy in treating partial-onset seizures. The prevalence of epilepsy in the U.S., estimated at 1.2 million adults and 470,000 children, underpins the demand for antiepileptic drugs (AEDs) like lacosamide [1]. The market has experienced steady growth, supported by increasing diagnosis rates and physician familiarity with the drug's profile.

Market size figures for lacosamide are not publicly disclosed by individual manufacturers due to competitive sensitivities. However, industry estimates for the broader antiepileptic drug market, which lacosamide contributes to, are significant. For example, the global AED market was valued at approximately $24 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 5% from 2023 to 2030 [2]. Lacosamide, as a relatively newer generation AED, is expected to capture a notable share of this growing market.

Growth drivers include:

• Increasing epilepsy prevalence: A consistent rise in diagnosed epilepsy cases in the U.S. directly translates to higher demand for effective treatments.
• Expanded indications and off-label use: While primarily indicated for partial-onset seizures, ongoing research and potential for expanded indications could further boost utilization.
• Generic competition and market entry: The expiration of key patents has opened the door for generic versions, increasing accessibility and potentially broadening the market reach, though it also impacts pricing.
• Physician and patient preference for newer AEDs: Lacosamide's generally favorable tolerability profile compared to older AEDs contributes to its adoption.

Challenges to growth include:

• Pricing pressures: The introduction of generics leads to significant price erosion, impacting revenue for both branded and generic manufacturers.
• Competition from other AEDs: The AED market is crowded, with numerous branded and generic options, creating intense competition.
• Reimbursement hurdles: Payer restrictions and formulary placement can influence prescription patterns.

What is the Patent Landscape for Lacosamide and its Impact on Market Exclusivity?

The patent landscape for lacosamide is a critical determinant of its market exclusivity and, consequently, its pricing. The originator of lacosamide, UCB Pharma, held primary patents that have since expired or are nearing expiration in key markets, including the U.S.

• Primary Composition of Matter Patent: The U.S. Patent No. 7,026,311, covering the composition of matter for lacosamide, was a key asset. This patent has expired, allowing for generic entry.
• Formulation and Method of Use Patents: UCB Pharma also secured patents related to specific formulations (e.g., oral, intravenous) and methods of use. The expiration dates of these secondary patents can provide additional periods of market protection or influence the timing and scope of generic competition.
• Orange Book Listings: The U.S. Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) lists patents and exclusivities associated with approved drug products. For lacosamide, the expiration of these patents, as reflected in the Orange Book, signifies the end of market exclusivity for the branded product and the potential for generic substitution [3].

The expiration of the primary composition of matter patent has resulted in the entry of multiple generic versions of lacosamide into the U.S. market. This has fundamentally altered the competitive landscape, leading to increased market penetration due to lower prices but also a decline in the revenue generated by the branded product. The presence of generic competition typically leads to rapid and significant price decreases.

How Have Pricing Trends for Lacosamide Evolved in the U.S. Market?

Pricing for lacosamide has undergone substantial shifts, primarily driven by the introduction of generic competition.

Branded Lacosamide (Vimpat®): Prior to generic entry, branded lacosamide commanded premium pricing. Manufacturer-reported wholesale acquisition costs (WAC) for Vimpat® varied based on dosage form (tablets, oral solution, injection) and strength. For example, in early 2023, WAC prices for 30 counts of 100 mg tablets could range from approximately $400 to $500. These prices reflect the value proposition of a novel AED and the period of market exclusivity.

Generic Lacosamide: Following the approval and market entry of generic lacosamide, the pricing landscape transformed. Generic manufacturers typically offer their products at significantly lower prices to gain market share.

• Price Erosion: Within months of the first generic approvals, average selling prices (ASPs) for lacosamide have seen a drastic reduction. Studies and market data from pharmacy benefit managers (PBMs) and wholesalers indicate that generic lacosamide can be acquired at prices that are 70-90% lower than the WAC of the branded product.
• Wholesale Acquisition Cost (WAC) vs. Average Wholesale Price (AWP) vs. Average Sales Price (ASP):
  • WAC: The list price set by the manufacturer before any discounts or rebates.
  • AWP: A benchmark price used for reimbursement, often higher than WAC due to markups by wholesalers.
  • ASP: The actual transaction price after discounts and rebates, reflecting the net price paid in the market. For generic drugs, ASP is a key indicator of competitive pricing.

Factors Influencing Current Pricing:

• Number of Generic Manufacturers: The presence of multiple generic manufacturers intensifies competition, driving prices down further.
• Volume Discounts and Rebates: PBMs and large purchasers negotiate significant discounts and rebates from generic manufacturers, leading to further price reductions at the payer level.
• Contractual Agreements: Pharmacy contracts and formulary placement agreements influence the net price paid by payers and pharmacies.

Projected Pricing Trends:

The U.S. market for lacosamide is expected to remain highly competitive, with generic versions dominating.

• Continued Price Pressure: Prices for generic lacosamide are likely to continue a downward trend, albeit at a slower pace than the initial post-launch erosion. This is driven by ongoing competition among generic manufacturers and the continuous push for cost containment by payers.
• Stabilization: Over the next 2-3 years, prices are expected to stabilize as the market matures, with a clear price hierarchy established among the various generic suppliers.
• Potential for Minor Fluctuations: Seasonal demand shifts, changes in manufacturing costs, or the entry of new generic competitors could cause minor price fluctuations.
• Differentiated Generic Offerings: Manufacturers may compete on factors beyond price, such as availability, supply chain reliability, and specific formulation nuances, which could lead to marginal pricing differences within the generic segment.

Table 1: Estimated U.S. Price Trends for Lacosamide (NDC: 50268-0789)

Product Type	Pre-Generic Entry (Approx. WAC per 30x100mg tabs)	Post-Generic Entry (Approx. ASP per 30x100mg tabs)	Projected Change (Next 2-3 Years)
Branded (Vimpat®)	$400 - $500	$100 - $200 (for remaining market share)	Decline, market share contraction
Generic	N/A	$30 - $80	Stabilization, minor erosion

Note: These figures are estimates based on industry averages and publicly available pricing benchmarks. Actual prices vary significantly based on payer contracts, rebates, and dispensing channels.

What is the Competitive Landscape for Lacosamide in the U.S.?

The U.S. competitive landscape for lacosamide (NDC: 50268-0789) is characterized by the transition from a single-branded product to a multi-generic market.

Key Market Participants:

1. UCB Pharma (Originator): While Vimpat® still holds a market presence, its share has diminished significantly due to generic competition. UCB may continue to focus on its niche or specific patient populations where branded preference persists.
2. Generic Manufacturers: A growing number of pharmaceutical companies have received FDA approval to market generic versions of lacosamide. These include:
   • Amneal Pharmaceuticals
   • Teva Pharmaceuticals
   • Apotex
   • Viatris (formerly Mylan and Pfizer Upjohn)
   • Sun Pharmaceutical Industries
   • Dr. Reddy's Laboratories
   • And others. The entry of these players has fragmented the market and driven down prices.

Competitive Factors:

• Price: This is the most significant factor in the generic lacosamide market. Manufacturers compete aggressively on price to secure market share with PBMs, wholesalers, and retail pharmacies.
• Product Availability and Supply Chain Reliability: Consistent and reliable supply is crucial. Manufacturers with robust supply chains can gain a competitive advantage, especially in a market where product stockouts can lead to significant patient and physician dissatisfaction.
• Formulation Bioequivalence: All generic products must demonstrate bioequivalence to the branded product. Variations in excipients or manufacturing processes that affect patient experience (e.g., tablet disintegration, taste of oral solution) can indirectly influence physician and patient choice, though formal preference is often based on cost.
• Dosage Forms: Lacosamide is available in multiple dosage forms: immediate-release tablets, extended-release tablets, and oral solution. The availability of all these forms by generic manufacturers is important for meeting diverse patient needs.
• Packaging and Dispensing Sizes: Offering a range of pack sizes can cater to different prescription lengths and pharmacy stocking strategies.

Market Dynamics:

• PBMs and Group Purchasing Organizations (GPOs): These entities wield significant power. They negotiate favorable pricing and rebate structures with generic manufacturers, influencing which products are placed on preferred formularies.
• Retail Pharmacy Chains: Major retail pharmacy chains often have preferred generic suppliers based on negotiated pricing and supply agreements.
• Physician Prescribing Habits: While price is a major driver for generic substitution, physician familiarity and historical prescribing patterns for certain generic manufacturers can play a role, particularly in the initial stages of generic availability.
• Patient Adherence: The availability of affordable generic options enhances patient adherence to prescribed treatment regimens, contributing to overall market volume.

The competitive environment is expected to remain intense. Manufacturers that can consistently offer competitive pricing while ensuring reliable supply and quality will likely capture the largest market share.

What are the Key Regulatory Considerations for Lacosamide in the U.S.?

The regulatory landscape for lacosamide (NDC: 50268-0789) in the U.S. is governed by the Food and Drug Administration (FDA). Key considerations include:

• Abbreviated New Drug Application (ANDA) Process: Generic versions of lacosamide must undergo the ANDA process, demonstrating bioequivalence to the reference listed drug (RLD), which is Vimpat®. This involves rigorous testing to prove that the generic drug performs the same as the brand-name drug in terms of safety and efficacy.
• Patent Certification (Paragraph IV Filings): Generic companies often file Paragraph IV certifications challenging existing patents held by the brand-name manufacturer. Successful Paragraph IV challenges can lead to market exclusivity for the first generic entrant and earlier market entry than otherwise allowed.
• Good Manufacturing Practices (GMP): All manufacturing facilities for lacosamide, whether for branded or generic products, must adhere to FDA's GMP regulations. This ensures the quality, purity, and potency of the drug product. Regular FDA inspections verify compliance.
• Labeling Requirements: Generic drug labels must be substantially the same as the RLD's label, but they can differ in certain aspects, such as the manufacturer's name, the inactive ingredients, and the expiration date. However, information regarding indications, dosages, administration, warnings, and contraindications must be consistent with the RLD.
• Post-Marketing Surveillance (Pharmacovigilance): Manufacturers are required to monitor and report adverse events associated with their drug products. This includes adverse event reporting for both branded and generic lacosamide.
• Orange Book Exclusivities and Patent Expirations: The FDA's Orange Book is critical for understanding patent and exclusivity data. Generic manufacturers rely on this information to determine when they can legally enter the market without infringing on existing patents or exclusivity periods [3].
• FDA Approval for New Indications: While generic lacosamide is approved for indications covered by the RLD, any new indications or significant formulation changes would require separate FDA review and approval.

The regulatory environment for generic drugs is designed to ensure that these products are safe and effective while also fostering competition to lower drug costs. The FDA's oversight ensures that lacosamide products available in the U.S. meet stringent quality standards.

How Will Market Dynamics and Patent Expirations Influence Future Price Projections?

The future price projections for lacosamide (NDC: 50268-0789) are intrinsically linked to its patent expiration timeline and the resulting market dynamics.

• Post-Patent Expiration: The expiration of the key composition of matter patent has already triggered significant price declines due to generic entry. This trend is irreversible for the foreseeable future.
• Generic Competition: The U.S. market is now a mature generic market for lacosamide. The presence of multiple generic manufacturers ensures continued price competition. New entrants are unlikely to significantly alter the trajectory, but they can maintain pressure.
• Consolidation and Market Share: Over time, there may be some consolidation among generic manufacturers, or certain players may gain dominant market share based on their ability to offer the lowest prices and maintain consistent supply. This could lead to a slight stabilization of prices for the dominant players.
• Payer Influence: Payers (insurance companies, PBMs) will continue to exert downward pressure on prices through formulary management, rebate negotiations, and preferred provider contracts. This will ensure that net prices remain low.
• Cost of Goods Sold (COGS): While generic manufacturers operate on thinner margins, their COGS are a fundamental determinant of their pricing floors. Fluctuations in raw material costs, manufacturing efficiency, and supply chain logistics can influence pricing, but typically result in modest adjustments rather than substantial shifts in a competitive generic market.
• Market Saturation: The market for lacosamide is largely saturated with generic options. Demand is primarily driven by the prevalence of epilepsy and physician prescribing habits, which are less sensitive to minor price fluctuations than to efficacy and safety.
• Absence of New Market Exclusivity Drivers: Unlike novel drug development where new patents, formulations, or indications can create new exclusivity periods and price increases, the lacosamide market is characterized by the ongoing lifecycle management of a genericized product. There are no immediate prospects for significant price increases driven by new patent protection or blockbuster indications.

Price Projections Summary:

• Next 1-2 Years: Expect continued, albeit moderate, price erosion for generic lacosamide as manufacturers jockey for market share and payers optimize their formularies. Prices may decrease by an additional 5-15%.
• Years 2-5: Prices are projected to stabilize. The downward trend will likely flatten out as the market reaches a pricing equilibrium driven by competitive dynamics and manufacturer cost structures. Minor fluctuations driven by supply or demand may occur, but significant increases are not anticipated.
• Long-Term Outlook: The market for lacosamide will remain a highly competitive generic space. Prices will likely track inflation at best, or continue a very slow erosion.

Table 2: Projected U.S. Average Selling Price (ASP) for Generic Lacosamide (NDC: 50268-0789) per 30x100mg Tablets

Timeframe	Projected ASP Range (USD)
Current (2024)	$30 - $80
Next 1-2 Years (2025-2026)	$25 - $70
Years 2-5 (2026-2029)	$20 - $65

These projections are based on current market trends and do not account for unforeseen regulatory changes, major shifts in manufacturing costs, or significant geopolitical events impacting supply chains.

Key Takeaways

• The U.S. market for lacosamide (NDC: 50268-0789) is a mature, genericized sector driven by the prevalence of epilepsy and the availability of cost-effective treatments.
• The expiration of key patents has led to significant price erosion, with generic lacosamide now representing the vast majority of the market.
• Competition among multiple generic manufacturers is intense, with price being the primary differentiator.
• Pricing is expected to continue its downward trend in the short term, followed by stabilization over the next 2-5 years.
• Regulatory oversight by the FDA ensures the safety and efficacy of all lacosamide products, whether branded or generic.

Frequently Asked Questions

1. Will the price of branded lacosamide (Vimpat®) significantly increase again? No, significant price increases for branded lacosamide are unlikely. The market is dominated by generic competition, and payer contracts generally favor lower-cost alternatives.

2. What is the primary driver for the decreasing price of generic lacosamide? The primary driver is the intense competition among multiple generic manufacturers vying for market share. This competition forces them to lower prices to secure contracts with payers and wholesalers.

3. Are there any pending patent challenges that could impact the generic lacosamide market? Given that the key patents have expired and generic products are already on the market, significant new patent challenges that would impact market entry are unlikely. The focus is now on post-expiry competition.

4. How do payer negotiations influence the final cost of lacosamide for patients? Payer negotiations are critical. Through formulary placement, rebates, and prior authorization requirements, payers significantly influence the net cost of lacosamide. This can lead to lower out-of-pocket costs for patients whose insurance covers the drug favorably.

5. What is the likelihood of new therapeutic indications being developed for lacosamide that could impact its market price? While ongoing research may explore new uses, the development of novel indications for a genericized drug typically does not lead to significant price increases for the generic versions. Any new development would likely involve a new patentable formulation or combination therapy, separate from the current generic market.

Citations

[1] Centers for Disease Control and Prevention. (2023, July 26). Epilepsy Fast Facts. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/epilepsy/about/fast-facts.htm

[2] Grand View Research. (2023). Antiepileptic Drugs Market Size, Share & Trends Analysis Report By Drug Class, By Type, By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030. Grand View Research.

[3] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/