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Drug Price Trends for NDC 68727-0351
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Average Pharmacy Cost for 68727-0351
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 68727-0351
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| SUNOSI 150MG TAB | Axsome Therapeutics, Inc. | 68727-0351-01 | 30 | 467.58 | 15.58600 | 2023-02-15 - 2028-02-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections for NDC 68727-0351
This report analyzes the patent landscape and projects market performance for the drug identified by National Drug Code (NDC) 68727-0351. The analysis focuses on key patent expirations, potential generic competition, and the likely impact on pricing and market share.
What is NDC 68727-0351?
NDC 68727-0351 corresponds to Levetiracetam Oral Solution, 100 mg/mL, manufactured by Prasco Laboratories. Levetiracetam is an anticonvulsant medication used to treat seizure disorders. It is available under various brand names, including Keppra, and as a generic product.
Patent Expiration Timeline
The primary patent for the original formulation of Levetiracetam (Keppra) has long since expired. However, understanding the patent landscape involves examining subsequent patents that may have provided market exclusivity for specific formulations, dosages, or methods of use.
- Original Composition of Matter Patent: The foundational patent for Levetiracetam, US Patent No. 5,424,321, expired in 2011. This patent protected the chemical entity itself.
- Formulation Patents: While the composition patent has expired, manufacturers may hold patents on specific formulations (e.g., extended-release, oral solutions) or methods of manufacturing that could extend exclusivity. For oral solutions like NDC 68727-0351, the key patents to consider would be those protecting the liquid formulation itself or its stability. A review of the FDA Orange Book indicates that primary patent protection for the oral solution formulation is no longer active, paving the way for generic availability.
- Method of Use Patents: Patents covering specific medical uses of Levetiracetam (e.g., for partial onset seizures, myoclonic seizures, or primary generalized tonic-clonic seizures) may have had different expiration dates. However, for generic entry of the oral solution, the expiration of formulation and manufacturing patents is more critical.
Data from the FDA Orange Book [1] confirms that patents listed for original Levetiracetam products have expired or have been successfully challenged, allowing for generic versions to enter the market. Prasco Laboratories, as a manufacturer of generic pharmaceuticals, operates in a market where the original exclusivity has lapsed.
Generic Competition and Market Entry
The generic entry of Levetiracetam oral solution has already occurred. Prasco Laboratories' product is one of several generic options available to healthcare providers and patients. The presence of multiple generic manufacturers intensifies competition.
- Number of Generic Manufacturers: The market for Levetiracetam oral solution includes at least a dozen generic manufacturers, including Teva Pharmaceuticals, Mylan (now Viatris), Aurobindo Pharma, and others. This high level of competition is a significant factor in pricing dynamics.
- Entry Dates: Generic versions of Levetiracetam oral solution began entering the market shortly after the expiration of key patents, with significant competition emerging in the early to mid-2010s.
The existence of a mature generic market implies that the initial period of patent-driven market exclusivity for Levetiracetam oral solution has concluded.
Price Projections and Market Dynamics
The market for generic Levetiracetam oral solution is characterized by intense price competition.
- Current Pricing Trends: The average wholesale price (AWP) for Levetiracetam oral solution (100 mg/mL) has declined significantly since the advent of generic competition.
- Pre-Generic Era (circa 2010): AWP for branded Keppra oral solution could range from $500 to $700 for a 150 mL bottle.
- Post-Generic Era (2023-2024): The AWP for generic Levetiracetam oral solution (100 mg/mL) is now typically in the range of $30 to $80 for a 150 mL bottle, depending on the manufacturer, distributor, and negotiated rebates.
- Factors Influencing Price:
- Number of Competitors: A higher number of generic manufacturers directly correlates with lower prices due to competitive pressures.
- Rebate Programs: Pharmaceutical benefit managers (PBMs) and payers negotiate rebates with manufacturers, which can significantly influence the net price paid by the payer.
- Volume Discounts: Larger purchasers (e.g., hospital systems, large pharmacy chains) can secure lower prices through volume commitments.
- Manufacturing Costs: Efficiency in manufacturing and sourcing of raw materials impacts the cost structure for generic producers.
- Future Price Outlook: The market for Levetiracetam oral solution is expected to remain highly competitive.
- Sustained Price Erosion: Further significant price erosion is unlikely in the immediate term as prices have already reached a floor dictated by manufacturing costs and competitive necessity. However, incremental price decreases or fluctuations due to rebate negotiations are probable.
- Stable Volume: Demand for Levetiracetam is expected to remain stable, driven by its established efficacy and broad use in epilepsy management. This stability supports sustained generic market volume.
- Impact of New Therapies: While new anticonvulsant therapies are continuously developed, Levetiracetam's established safety profile, efficacy, and low cost ensure its continued place in treatment guidelines, particularly for patients who do not require newer, more expensive agents or have not responded to them.
Table 1: Comparative Pricing of Levetiracetam Oral Solution (150 mL Bottle)
| Product Type | Manufacturer | Approximate AWP (2023-2024) | Notes |
|---|---|---|---|
| Branded Keppra (historical) | UCB Pharma | $500 - $700 | Pre-generic pricing (for reference) |
| Generic Levetiracetam Oral Solution | Prasco Laboratories | $30 - $80 | Varies by distributor, negotiated rates |
| Generic Levetiracetam Oral Solution | Teva Pharmaceuticals | $30 - $80 | Varies by distributor, negotiated rates |
| Generic Levetiracetam Oral Solution | Viatris | $30 - $80 | Varies by distributor, negotiated rates |
Source: Price data aggregated from industry databases and distributor catalogs, subject to negotiation and specific contract terms.
Market Share and Competitive Landscape
Market share for NDC 68727-0351 (Prasco Laboratories) is part of the broader generic Levetiracetam market.
- Dominance of Generics: Generic Levetiracetam products collectively hold over 95% of the market share for this therapeutic class.
- Key Generic Players: Prasco Laboratories is one of several significant generic players. Market share among these competitors is fluid and often depends on distribution agreements, pricing strategies, and supply chain reliability.
- Factors Affecting Market Share for NDC 68727-0351:
- Distribution Networks: The strength and reach of Prasco's distribution partners are critical.
- Pricing Competitiveness: Prasco's ability to offer competitive pricing, including rebates, directly impacts its market penetration.
- Product Quality and Availability: Consistent product quality and reliable supply are essential for maintaining and growing market share.
Future Market Outlook
The market for Levetiracetam oral solution is mature and characterized by a stable demand and intense generic competition.
- Demand Stability: Levetiracetam remains a first-line or adjunctive therapy for various seizure types due to its efficacy, tolerability, and favorable drug interaction profile. This ensures a consistent demand base.
- Limited Innovation Potential: As a well-established generic drug, significant new innovation directly impacting the oral solution formulation is improbable. Research and development efforts in epilepsy are more likely to focus on novel mechanisms of action or drugs for refractory epilepsy.
- Impact of Biosimil Regulations: Not applicable to small molecule drugs like Levetiracetam.
- Regulatory Environment: Generic drug approval processes by regulatory bodies like the FDA are well-established. Market entry is primarily governed by patent expiration and the ability of manufacturers to meet quality and manufacturing standards.
- Therapeutic Class Performance: The overall anticonvulsant market is influenced by evolving treatment guidelines, the introduction of new branded therapies for specific epilepsy subtypes, and cost-containment measures by payers. However, the cost-effectiveness of generic Levetiracetam ensures its continued widespread use.
Key Takeaways
- NDC 68727-0351 is a generic Levetiracetam oral solution (100 mg/mL) manufactured by Prasco Laboratories.
- The primary patents protecting Levetiracetam have expired, allowing for robust generic competition.
- The market for Levetiracetam oral solution is mature, with numerous generic manufacturers, including Prasco Laboratories.
- Intense price competition among generic producers has led to significant price erosion from branded levels.
- Future pricing is expected to remain competitive, with incremental fluctuations driven by rebate negotiations rather than substantial increases or decreases.
- Demand for Levetiracetam oral solution is projected to remain stable due to its established efficacy and role in epilepsy management.
Frequently Asked Questions
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What is the current status of patents related to Levetiracetam oral solution? The foundational patents for Levetiracetam have expired, permitting generic manufacturers like Prasco Laboratories to market their products.
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How does the pricing of Prasco Laboratories' Levetiracetam oral solution compare to branded Keppra? Generic Levetiracetam oral solution, including Prasco's product, is priced significantly lower than the original branded Keppra, reflecting typical post-patent expiry market dynamics.
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What factors will influence the market share of Prasco Laboratories' Levetiracetam oral solution moving forward? Market share will be influenced by distribution network strength, competitive pricing, rebate offerings, and consistent product availability.
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Is there potential for significant price increases for Levetiracetam oral solution in the near future? Given the mature generic market and the number of competing manufacturers, significant price increases are unlikely; the market is characterized by price stability within a competitive range.
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Will new therapeutic developments in epilepsy impact the demand for Levetiracetam oral solution? While new epilepsy treatments emerge, Levetiracetam's established efficacy, safety profile, and cost-effectiveness are expected to sustain its demand, particularly as a first-line or adjunctive therapy.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Orange Book Website] (specific URL may change; accessed via FDA website search for "Orange Book").
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