Last updated: February 17, 2026
What Is the Market Status of NDC 00555-0882?
NDC 00555-0882 is a branded drug marketed by Teva Pharmaceuticals. It is identified as Levetiracetam, commonly prescribed for epilepsy management. The product competes in the neurological drug sector, which includes numerous generic and branded anticonvulsants. The market for levetiracetam has experienced consistent growth, driven by the increasing prevalence of epilepsy and neurological disorders globally.
How Competitive Is the Market for Levetiracetam?
Levetiracetam holds a significant market share within the epilepsy medication sector. Major competitors include:
- Keppra (Roche/Teva)
- Generic levetiracetam formulations
The drug's patent expired in the United States in 2015, following which generic versions entered the market. Despite this, branded versions maintain pricing power due to brand recognition and prescriber loyalty.
What Are the Current Pricing Trends?
Pricing varies geographically, but typical trends include:
-
United States:
- Brand-name Keppra (Teva): Retail prices range from $2,000 to $3,500 per month.
- Generic levetiracetam: Prices range from $300 to $600 per month.
-
International Markets:
- Competitive pricing often reduces to a quarter of U.S. prices, with significant variation based on local patent status and healthcare policies.
Prices have stabilized post-patent expiry, with generics capturing substantial market share. Recent trends indicate a gradual decline in average market prices for levetiracetam, aligning with increased generic penetration.
What Is the Market Size and Future Projection?
Historical Market Data:
- The global epilepsy drug market was valued at approximately $4 billion in 2022.
- Levetiracetam accounts for around 30-40% of the market.[1]
- US sales for Keppra and generics combined exceeded $2 billion in 2022.
Future Market Projections:
- Expected Compound Annual Growth Rate (CAGR): 3-5% from 2023 to 2028.
- Drivers include: rising epilepsy incidence, expanded indications, and increasing use of combination therapies.
- Market estimates project the global levetiracetam revenue will surpass $2.3 billion by 2028.[2]
Key Factors Influencing Market Dynamics:
- Patent expirations and the evolving landscape of generics.
- Pricing pressures due to insurance and national formularies.
- Emergence of biosimilars and alternative therapies.
What Are the Policy and Regulatory Considerations?
The US FDA approved the original formulation of Keppra in 2000. Subsequent generic approvals occurred in 2015, leading to increased price competition. Country-specific policies affect pricing:
- United States: Strict patent enforcement and reimbursement policies influence brand versus generic uptake.
- European Union: Generally broader acceptance of generics, leading to lower prices.
- Emerging Markets: Often faced with limited patent enforcement, resulting in more significant generic market shares.
How Might Price Projections Evolve?
Based on current trends:
| Year |
Estimated Retail Price Range (per month) |
Notes |
| 2023 |
$300 - $600 (generics) |
Prices stabilize after patent expiry |
| 2025 |
$250 - $550 |
Market saturation influences slight decrease |
| 2028 |
$200 - $500 |
Further generic market penetration |
The actual prices will depend on regional policies, healthcare negotiations, and competition dynamics.
Key Takeaways
- Market size: Approximately $1.2 billion globally for levetiracetam in 2022.
- Growth trajectory: Expected CAGR of 3-5%, indicating steady expansion.
- Pricing: Generic options dominate, with significant reductions compared to branded versions.
- Competitive landscape: Dominated by Teva’s Keppra and generic formulations.
- Policy impacts: Patent expirations and healthcare reforms shape market prices and access.
FAQs
1. How does the patent status of NDC 00555-0882 affect its market price?
Patent expiration in 2015 allowed generic competition, leading to significant price declines and market share shifts toward generics.
2. What strategies could impact the pricing of levetiracetam?
Manufacturers may offer discounts, bundle with other therapies, or expand indications to maintain market share and influence pricing.
3. Which geographic markets present the highest growth potential?
Emerging markets in Asia, Latin America, and parts of Europe are experiencing growth due to increasing epilepsy diagnosis and lower generic penetration.
4. Are biosimilars relevant to levetiracetam?
No. Biosimilars are biological products; levetiracetam is a small-molecule antiepileptic drug. Future innovations could include new formulations or combination therapies.
5. What upcoming regulatory changes could impact levetiracetam’s market?
Potential new generic approvals, policy shifts favoring biosimilars, or pricing reforms in key markets could influence future prices.
References
[1] MarketResearch.com, “Global Epilepsy Drug Market,” 2022.
[2] IQVIA, “Pharmaceutical Market Reports,” 2022.
