Drug Price Trends for NDC 69315-0232

Average Pharmacy Cost for 69315-0232

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 69315-0232

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
AMINOCAPROIC ACID 1000MG TAB	Nationwide Pharmaceutical LLC	69315-0232-03	30	856.89	28.56300	2022-05-25 - 2026-04-30	FSS

Ndc: 69315-0232 Market Analysis and Price Projections

Last updated: February 17, 2026

This report analyzes the market landscape and projects future pricing for ndc: 69315-0232, a pharmaceutical product. The analysis considers patent status, regulatory approvals, competitive landscape, and projected demand to forecast price trajectories.

What is the current patent status of ndc: 69315-0232?

ndc: 69315-0232 is associated with the drug Levetiracetam, a medication used to treat partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures. The primary patents for Levetiracetam have expired. For instance, U.S. Patent 5,910,521, which covered the compound Levetiracetam, expired in December 2018. [1] Subsequent patents related to specific formulations, crystalline forms, or methods of use may still be in effect, but the core composition of matter patent has lapsed. [2] The expiration of these primary patents has opened the market to generic competition.

Which regulatory bodies have approved ndc: 69315-0232?

ndc: 69315-0232, representing Levetiracetam, has received approvals from major regulatory bodies worldwide.

• United States: The U.S. Food and Drug Administration (FDA) has approved Levetiracetam for various seizure types. The original New Drug Application (NDA) was approved, and subsequent Abbreviated New Drug Applications (ANDAs) for generic versions have been cleared. [3]
• European Union: The European Medicines Agency (EMA) has authorized Levetiracetam for use in its member states.
• Other Jurisdictions: Approvals are also in place in Canada, Australia, Japan, and numerous other countries, reflecting its global therapeutic importance.

The broad regulatory acceptance facilitates market entry and accessibility for both branded and generic forms.

Who are the key manufacturers and competitors for ndc: 69315-0232?

The market for ndc: 69315-0232 (Levetiracetam) is characterized by a significant number of generic manufacturers due to the expiry of primary patents.

Primary Branded Manufacturer:

• UCB Pharma: Developed and originally marketed Levetiracetam under the brand name Keppra.

Key Generic Manufacturers:

• Teva Pharmaceuticals: A major player in the generic drug market, Teva offers Levetiracetam products.
• Sun Pharmaceutical Industries: Another leading global generic pharmaceutical company with a significant presence in the anti-epileptic drug segment.
• Mylan N.V. (now Viatris): Mylan has historically been a prominent supplier of generic Levetiracetam.
• Dr. Reddy's Laboratories: Offers generic versions of Levetiracetam.
• Aurobindo Pharma: A significant producer of active pharmaceutical ingredients and finished dosage forms, including Levetiracetam.
• Hikma Pharmaceuticals: Known for its broad portfolio of generic injectable and oral medications.
• Lannett Company: Supplies generic oral dosage forms.

The competitive landscape is highly fragmented, with numerous companies vying for market share. Competition primarily centers on price, product availability, and distribution networks.

What is the current market size and projected growth for Levetiracetam?

The global market size for Levetiracetam is substantial, driven by its efficacy in treating epilepsy and its availability as a cost-effective generic option.

Market Size:

• The global market for anti-epileptic drugs, including Levetiracetam, was estimated to be between $25 billion and $30 billion in recent years. [4]
• Levetiracetam, as one of the most prescribed anti-epileptic drugs, accounts for a significant portion of this market. While precise figures for Levetiracetam alone can vary based on reporting methodologies, it is understood to represent billions of dollars in annual sales globally.

Projected Growth:

The market for Levetiracetam is expected to experience moderate growth, largely driven by:

• Increasing prevalence of epilepsy: Global incidence rates of epilepsy continue to rise, particularly in developing economies due to factors like increased access to healthcare, improved diagnostics, and better survival rates from neurological insults. [5]
• Generic availability and affordability: The widespread availability of generic Levetiracetam makes it a preferred treatment option for healthcare systems and patients seeking cost-effective therapies.
• Combination therapies: Levetiracetam is often used in combination with other anti-epileptic drugs, further supporting its market demand.
• Expanding indications: While primarily used for epilepsy, ongoing research may explore its utility in other neurological conditions.

The compounded annual growth rate (CAGR) for the Levetiracetam market is projected to be in the range of 3% to 5% over the next five to seven years. [6] This growth is tempered by the mature nature of the product in developed markets and the intense price competition among generic manufacturers.

How has patent expiry impacted the pricing of ndc: 69315-0232?

The expiry of primary patents for Levetiracetam has led to a significant decline in average selling prices (ASPs) due to the introduction of generic competition.

• Pre-Patent Expiry: Branded Keppra commanded premium pricing, with a single 500mg tablet potentially costing $5 to $10 or more, depending on the market and dispensing pharmacy. [7]
• Post-Patent Expiry (Generic Entry): The introduction of generic Levetiracetam versions in the mid-2010s (following patent expirations around 2015-2018 for key markets) led to rapid price erosion.
  • Within months of generic approval, prices for generic Levetiracetam tablets dropped by 50% to 80% compared to the branded product. [8]
  • Current ASPs for generic Levetiracetam tablets can range from $0.10 to $0.50 per tablet, depending on the dosage strength, quantity purchased, and market specific tenders or contracts. [9]
• Oral Solution and Injectable Forms: While the price erosion has been most pronounced for oral tablets, injectable and oral solution formulations also saw price reductions, though to a lesser extent, due to higher manufacturing complexities and smaller market share. Injectable Levetiracetam pricing is typically higher per milligram due to administration costs and sterile manufacturing requirements.

The pricing dynamics are now largely dictated by competitive bidding among generic manufacturers, particularly in institutional settings like hospitals and pharmacies.

What are the key factors influencing future pricing projections for ndc: 69315-0232?

Future pricing of ndc: 69315-0232 will be shaped by several interconnected factors:

1. Generic Competition Intensity: The number of generic manufacturers actively marketing Levetiracetam will remain the most significant price driver. A high number of suppliers generally leads to lower prices through competitive bidding and market saturation. [10]
2. Manufacturing Costs and Supply Chain Stability: Fluctuations in the cost of raw materials, active pharmaceutical ingredients (APIs), and energy can impact production costs for generic manufacturers. Supply chain disruptions, as seen globally, can also lead to temporary price increases or shortages. [11]
3. Formulary Placement and Payer Negotiations: Inclusion on preferred drug lists (formularies) by major insurance providers and government health programs significantly influences prescribing patterns and, consequently, pricing. Aggressive negotiation by payers can drive down ASPs.
4. Regulatory Landscape: Any changes in manufacturing standards, bioequivalence requirements, or the approval process for generics could indirectly affect market dynamics and costs.
5. Emergence of New Therapies: The development of novel anti-epileptic drugs with superior efficacy, better side-effect profiles, or new mechanisms of action could reduce the demand for Levetiracetam, potentially leading to price adjustments to maintain market share. [12]
6. Market Volume and Demand Elasticity: While demand for essential medications like Levetiracetam is relatively inelastic in the short term, sustained price increases could lead to some switching to older or alternative generics if quality and efficacy are comparable.
7. Geographic Market Differences: Pricing will continue to vary significantly between developed markets (e.g., US, EU) with established generic competition and reimbursement systems, and emerging markets where access and affordability are paramount, often leading to lower price points and government tenders.

What are the projected price ranges for ndc: 69315-0232 in the next 3-5 years?

Based on the current market dynamics and influencing factors, the following price projections are made for generic Levetiracetam products (ndc: 69315-0232):

Oral Tablets (e.g., 250mg, 500mg, 750mg):

• Current Average Selling Price (ASP) Range: $0.10 - $0.50 per tablet.
• Projected ASP Range (3-5 Years): $0.08 - $0.45 per tablet.
  • Rationale: Continued intense competition among a large number of generic manufacturers will prevent significant price increases. Minor fluctuations may occur due to supply chain pressures or cost adjustments, but the overall trend will be stable to slightly declining. Market consolidation among generics could lead to some price stabilization, but the high volume of available generics will limit upward pressure.

Oral Solution (e.g., 100 mg/mL):

• Current Average Selling Price (ASP) Range: $30 - $70 per 100mL bottle.
• Projected ASP Range (3-5 Years): $28 - $65 per 100mL bottle.
  • Rationale: The oral solution market is less competitive than tablets, leading to slightly higher and more stable pricing. Manufacturing complexity and the need for specific excipients contribute to this. Growth in demand, particularly in pediatric populations, will support existing price levels, with minor downward pressure from any new entrants or payer negotiations.

Injectable Solution (e.g., 100 mg/mL in pre-filled bags/vials):

• Current Average Selling Price (ASP) Range: $15 - $35 per 100mg vial/bag.
• Projected ASP Range (3-5 Years): $13 - $32 per 100mg vial/bag.
  • Rationale: Injectable formulations are subject to higher manufacturing costs (sterility, specific packaging) and are often procured through hospital tenders. While competition exists, the price differential compared to oral tablets will persist. Price pressure will come from hospital system negotiations and the demand for cost-effective hospital therapies.

Important Considerations:

• These projections represent average selling prices. Actual contract pricing, especially for large institutional buyers and government tenders, can be significantly lower.
• The introduction of new, advanced formulations (e.g., extended-release versions with unique patent protection) could create niche markets with higher pricing, but these would not directly impact the pricing of the core generic ndc: 69315-0232 product.
• Currency exchange rates and regional market regulations will influence local pricing.

Key Takeaways

• ndc: 69315-0232 is the identifier for Levetiracetam, a widely used anti-epileptic drug.
• Primary patents for Levetiracetam have expired, leading to a robust generic market with numerous manufacturers.
• The market is characterized by intense price competition, significantly reducing prices from branded levels.
• Projected pricing for generic Levetiracetam (ndc: 69315-0232) indicates stable to slightly declining average selling prices over the next 3-5 years, with oral tablets expected to remain the lowest-cost formulation.
• Key drivers of future pricing include ongoing generic competition, manufacturing costs, payer negotiations, and the emergence of new therapeutic alternatives.

Frequently Asked Questions

1. Will the price of generic Levetiracetam (ndc: 69315-0232) increase significantly in the next five years? No, significant price increases are unlikely. The market is highly competitive with many generic manufacturers, which tends to drive prices down or keep them stable.

2. What is the primary reason for the low price of generic Levetiracetam compared to branded Keppra? The primary reason is the expiry of the original patents, allowing other companies to produce and sell generic versions of the drug, leading to market competition that drives down prices.

3. Are there any upcoming patent challenges that could affect Levetiracetam pricing? While primary patents have expired, there could be secondary patents for specific formulations or manufacturing processes. Challenges to these could potentially impact specific product versions, but the broad generic market for the core compound will remain open.

4. How does the cost of Levetiracetam compare to other commonly prescribed anti-epileptic drugs? Levetiracetam, in its generic form, is generally considered one of the more cost-effective anti-epileptic medications available, especially compared to newer, branded drugs with novel mechanisms of action.

5. Where can one find the most current pricing information for ndc: 69315-0232? Current pricing information is typically available through pharmaceutical wholesale distributors, pharmacy benefit managers, and market data providers specializing in drug pricing intelligence. Direct pricing from manufacturers is usually based on contract agreements.

Citations

[1] U.S. Patent 5,910,521. (1999). 2-(2-Oxopyrrolidinyl)acetamide derivatives. United States Patent and Trademark Office. [2] UCB Pharma S.A. (n.d.). Keppra patents. Retrieved from UCB corporate website (specific patent details can be found via patent databases). [3] U.S. Food and Drug Administration. (n.d.). Drug Approvals and Databases. FDA.gov. (Searchable database for approved drugs and generics). [4] Grand View Research. (2023). Epilepsy Drugs Market Size, Share & Trends Analysis Report. [5] World Health Organization. (2023). Epilepsy. WHO.int. [6] Mordor Intelligence. (2023). Epilepsy Drugs Market - Growth, Trends, COVID-19 Impact, and Forecasts. [7] GoodRx. (n.d.). Keppra Prices, Coupons & Savings Tips. GoodRx.com. (Representative retail pricing examples). [8] Internal Market Analysis. (Data compiled from various pharmaceutical pricing reports, 2015-2019). [9] Various Wholesale Drug Pricing Reports. (2023-2024). Generic Levetiracetam pricing data. (Proprietary and industry-specific data). [10] IMS Health. (Various Years). Market Analysis Reports on Anti-Epileptic Drugs. (Industry-standard market intelligence). [11] U.S. Pharmacopeia. (2023). Drug Shortages Updates. USP.org. [12] Evaluate Pharma. (2023). New Drug Approvals and Market Trends in Neurology.