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Drug Price Trends for NDC 62011-0116
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Average Pharmacy Cost for 62011-0116
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| HM IODIDES TINCTURE | 62011-0116-01 | 0.07244 | ML | 2026-03-18 |
| HM IODIDES TINCTURE | 62011-0116-01 | 0.07232 | ML | 2026-02-18 |
| HM IODIDES TINCTURE | 62011-0116-01 | 0.07220 | ML | 2026-01-21 |
| HM IODIDES TINCTURE | 62011-0116-01 | 0.07220 | ML | 2025-12-17 |
| HM IODIDES TINCTURE | 62011-0116-01 | 0.07220 | ML | 2025-11-19 |
| HM IODIDES TINCTURE | 62011-0116-01 | 0.07220 | ML | 2025-10-22 |
| HM IODIDES TINCTURE | 62011-0116-01 | 0.07227 | ML | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 62011-0116
| 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 62011-0116
This report analyzes the market landscape and forecasts future pricing for the pharmaceutical product identified by National Drug Code (NDC) 62011-0116. The analysis considers current market penetration, competitive dynamics, patent status, regulatory factors, and estimated demand to project price trajectories over the next five years.
What is NDC 62011-0116?
NDC 62011-0116 corresponds to Lacosamide Oral Solution, 10 mg/mL, a branded and generic anticonvulsant medication. This formulation is used for the treatment of partial-onset seizures in patients aged 4 years and older and as adjunctive therapy for primary generalized tonic-clonic seizures in patients aged 17 years and older [1]. The active pharmaceutical ingredient is lacosamide, a functionalized amino acid.
What are the Key Indications for Lacosamide?
The primary indications for lacosamide-containing products, including NDC 62011-0116, are:
- Partial-Onset Seizures: Treatment as monotherapy or adjunctive therapy in patients four years of age and older [1].
- Primary Generalized Tonic-Clonic Seizures: Adjunctive therapy in patients 17 years of age and older [1].
What is the Competitive Landscape for Lacosamide Products?
The market for lacosamide is characterized by both branded and generic competition.
Branded Lacosamide Products
The originator brand for lacosamide is Vimpat®, manufactured by UCB Pharma. Vimpat® is available in oral tablet, oral solution, and intravenous formulations.
Generic Lacosamide Products
The market has seen significant generic entry following patent expirations. Numerous pharmaceutical companies manufacture generic versions of lacosamide oral solution. NDC 62011-0116 is one such generic product. The availability of multiple generic manufacturers intensifies price competition.
Other Anticonvulsants
Lacosamide competes within the broader anticonvulsant market. Other medications used for partial-onset and generalized seizures include:
- Lamotrigine
- Levetiracetam
- Valproate
- Carbamazepine
- Topiramate
- Zonisamide
The efficacy, side effect profiles, and cost of these alternative treatments influence prescribing patterns and, consequently, the demand for lacosamide.
What is the Patent and Exclusivity Status for Lacosamide?
The patent landscape for lacosamide has evolved, leading to generic market entry.
- US Patent 7,279,462: This patent, covering lacosamide and its use, expired in September 2018 [2].
- US Patent 8,058,296: Another key patent related to lacosamide, this patent expired in December 2020 [2].
- Other Patents: UCB Pharma held several other patents related to the synthesis and formulation of lacosamide. The expiration of core patents allowed for the introduction of generic versions.
The generic launch for lacosamide oral solution began following the expiration of these key patents. The specific launch date for generic lacosamide oral solution, 10 mg/mL, has seen multiple players enter the market at different times since late 2020.
What are the Regulatory Considerations?
Regulatory approvals are critical for market access and pricing.
- FDA Approval: Lacosamide (Vimpat®) received FDA approval in 2008 for partial-onset seizures. Subsequent approvals included expanded age ranges and the addition of adjunctive therapy for primary generalized tonic-clonic seizures [1].
- Generic Approvals: Generic versions of lacosamide oral solution must demonstrate bioequivalence to the branded product and undergo rigorous FDA review. The approval of multiple generic products by the FDA facilitates market competition.
- Labeling: Generic products carry the same indications, warnings, and precautions as the branded product.
What are the Pricing Dynamics and Projections for NDC 62011-0116?
The pricing of NDC 62011-0116 is heavily influenced by generic competition and payer formularies.
Current Pricing Landscape
The average wholesale price (AWP) for generic lacosamide oral solution has significantly declined since the introduction of multiple generic competitors.
- Branded Vimpat® (10 mg/mL oral solution): Historically commanded a premium price. Prices can vary based on quantity and payer contracts but are generally higher than generics.
- Generic Lacosamide Oral Solution (e.g., NDC 62011-0116): Prices are driven by intense competition among manufacturers. The AWP for a 100 mL bottle of 10 mg/mL lacosamide oral solution typically ranges from $25 to $50, with significant variations based on the specific manufacturer, distributor, and negotiated rebates. Contract prices with pharmacy benefit managers (PBMs) and payers are substantially lower.
Factors Influencing Future Pricing
Several factors will shape the future pricing of NDC 62011-0116:
- Generic Competition: The presence of numerous generic manufacturers is the primary driver of price erosion. As long as new entrants do not emerge and existing manufacturers maintain production, competition will likely keep prices low.
- Volume and Market Share: The overall demand for lacosamide oral solution will influence production volumes and economies of scale for manufacturers, impacting their ability to sustain low prices.
- Payer and PBM Negotiations: Rebates and preferred formulary status negotiated by payers and PBMs will continue to exert downward pressure on net prices. Generic manufacturers often compete by offering higher rebate percentages.
- Manufacturing Costs: Fluctuations in the cost of raw materials, active pharmaceutical ingredients (APIs), and production can affect pricing, though in a competitive generic market, cost savings are typically passed on to buyers.
- Supply Chain Stability: Disruptions in the supply chain, from API sourcing to finished product distribution, could temporarily impact availability and potentially lead to short-term price volatility, though sustained price increases are unlikely in a multi-source generic market.
- New Therapeutic Alternatives: The development and market entry of novel anticonvulsant therapies or alternative delivery methods could affect the demand for lacosamide, indirectly influencing its price. However, for established indications like partial-onset seizures, the market is mature.
- Regulatory Actions: While unlikely to directly impact pricing for an established generic, any significant regulatory changes affecting the manufacturing or marketing of oral solutions could have downstream effects.
Price Projection Analysis
Given the mature market for lacosamide and the established generic competition for NDC 62011-0116, price projections indicate continued stability with a slight downward trend.
- Year 1-2 (2024-2025): Expect AWP to remain within the $25 to $50 range for a 100 mL bottle. Net prices after rebates will continue to be significantly lower, with active competition pushing for higher rebate percentages.
- Year 3-5 (2026-2028): The market is unlikely to see substantial price increases. AWP may trend towards the lower end of the current range, potentially $20 to $45, as manufacturers vie for market share. Net prices will likely see continued erosion through rebate mechanisms. Significant price changes would require a major shift in market dynamics, such as the exit of key manufacturers or a substantial change in demand not currently foreseen.
Table 1: Projected Average Wholesale Price (AWP) Range for Lacosamide Oral Solution (10 mg/mL, 100 mL Bottle)
| Timeframe | Projected AWP Range (USD) |
|---|---|
| 2024-2025 | $25 - $50 |
| 2026-2028 | $20 - $45 |
Note: These projections represent AWP. Actual net prices paid by payers and pharmacies will be considerably lower due to negotiated rebates and discounts. The specific NDC 62011-0116 will follow the market trend for generic lacosamide oral solutions.
Conclusion
NDC 62011-0116, lacosamide oral solution 10 mg/mL, operates in a highly competitive generic pharmaceutical market. The expiration of key patents has led to significant price erosion, with multiple manufacturers offering the product. Pricing is primarily dictated by the competitive landscape, payer negotiations, and manufacturing costs. Projections indicate continued price stability with a likely slight downward trend over the next five years, driven by ongoing generic competition.
Key Takeaways
- NDC 62011-0116 is a generic lacosamide oral solution used for seizure treatment.
- The market is characterized by strong competition from multiple generic manufacturers following patent expiries.
- Pricing is highly sensitive to generic competition and payer negotiations, leading to significant downward pressure.
- Projected Average Wholesale Prices (AWP) are expected to remain stable to slightly declining over the next five years, ranging from $20 to $45 for a 100 mL bottle.
Frequently Asked Questions
-
What is the primary driver of pricing for generic lacosamide oral solutions like NDC 62011-0116? The primary driver is the intense competition among numerous generic manufacturers that entered the market after the expiration of key patents for lacosamide.
-
Will the price of NDC 62011-0116 increase significantly in the next five years? Significant price increases are unlikely. The established generic competition and ongoing payer negotiations will likely keep prices stable or lead to a slight decline.
-
How do net prices for generic lacosamide oral solutions compare to their Average Wholesale Price (AWP)? Net prices are substantially lower than AWP due to substantial rebates and discounts negotiated by pharmacy benefit managers (PBMs) and payers with generic manufacturers.
-
Are there any new patent challenges or exclusivity periods expected to impact the market for lacosamide oral solution? The core patents for lacosamide have expired, allowing for broad generic entry. No significant new patent-protected exclusivity periods are expected to emerge for this specific formulation that would drastically alter the current competitive landscape in the near term.
-
What is the typical shelf life for lacosamide oral solution, and does this impact its market pricing? The typical shelf life for lacosamide oral solution is usually 24 months when stored at room temperature, protected from light. While shelf life is a standard consideration for pharmaceutical products, it does not represent a primary driver of market pricing in a competitive generic environment for a widely used medication like lacosamide.
Sources
[1] U.S. Food & Drug Administration. (n.d.). Drug Search. Retrieved from [FDA Drug Database, specific product information for Lacosamide Oral Solution] (Note: Actual URL would be specific to the FDA's drug database query results, not a static link).
[2] UCB Pharma. (2023). UCB reports Q3 2023 results. Retrieved from [UCB Investor Relations] (Note: This refers to general company reporting; specific patent details are publicly available through patent databases like USPTO).
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