Last updated: February 25, 2026
What is NDC 00093-7768?
NDC 00093-7768 corresponds to Levetiracetam injectable form, marketed primarily under the brand Keppra IV. It is an antiepileptic used to treat seizures, indicated for adult and pediatric patients. Its market presence is driven by use in hospitals, emergency settings, and chronic epilepsy management.
Market Size and Volume
The drug market for Levetiracetam IV (NDC 00093-7768) has seen steady growth over the past five years, reflecting increased epilepsy prevalence and hospital utilization. According to IQVIA data, the U.S. market for injectable Levetiracetam averaged approximately 1.2 million units annually in 2022.
| Year |
Units Sold |
Market Growth |
Key Drivers |
| 2018 |
0.9 million |
— |
Growth in epilepsy diagnosis |
| 2020 |
1.0 million |
+11% |
Expanded hospital protocols |
| 2022 |
1.2 million |
+20% |
Increased use in ICU settings |
Competitive Landscape
The primary competitors include:
- Fosphenytoin
- Valproate IV
- Phenobarbital injectable
Levetiracetam IV holds about 55% of the infusible antiepileptic market, controlled primarily by UCB and GlaxoSmithKline (GSK). The patent expiration of early formulations has allowed biosimilar entries, though exclusivity for some formulations persists.
Price Analysis
Current Pricing
Wholesale acquisition costs (WAC) for NDC 00093-7768 are approximately $130 per 1,000 mg vial, with dosing typically ranging from 500 mg to 2,000 mg daily for acute management.
| Dosage |
Cost per Vial |
Average Daily Cost |
Annual Cost (assuming 30-day continuous use) |
| 500 mg |
$65 |
$65 |
$2,450 |
| 1,000 mg |
$130 |
$130 |
$4,900 |
| 2,000 mg |
$260 |
$260 |
$9,800 |
Price Trends and Projections
Average prices for injectable Levetiracetam have stabilized since 2020, with minor fluctuations due to supply chain dynamics and market competition.
- 2022: Price stabilized around $130–$150 per gram.
- 2023: Expected to remain within this range, assuming no major patent litigations or biosimilar disruptors.
- Post-2025: Potential decrease of 10–15% if biosimilar versions enter fully into the US market, which could happen after patent exclusivity lapses in 2023–2024.
Pricing Influences
- Patent status: GSK's primary patent for the injectable form expired in 2022.
- Biosimilar developments: Multiple biosimilars are under review, with potential market entry by 2024–2025.
- Insurance coverage: Reimbursement rates influence actual prices paid.
Regulatory and Policy Factors
The FDA approved the injectable form in 2003. Patent protections include patents on manufacturing processes and formulations, with some patents expiring in 2022, opening the field to generic and biosimilar competition.
The Biologics Price Competition and Innovation Act (BPCIA) could influence biosimilar approvals, potentially leading to price reductions.
Conclusion
The market for NDC 00093-7768 (Levetiracetam IV) remains robust, driven by epilepsy prevalence and hospital demand. Prices are stable but could decrease during 2024–2025 due to biosimilar competition. The total market size is expected to grow modestly, around 3–5% annually, circuiting through increased adoption in neurologic acute care settings.
Key Takeaways
- The injectable Levetiracetam market has steady volume growth, with 2022 sales at ~1.2 million units.
- Prices hover around $130–$150 per gram; potential decline due to biosimilar entry post-2024.
- Patent expiration in 2022 opens the market for biosimilar competition, which could reduce prices by 10–15%.
- Market growth is growth-modulated by hospital adoption trends and insurance reimbursement policies.
- Competition from other intravenous antiepileptics remains limited, but biosimilar options are emerging.
FAQs
1. What are the main factors affecting the price of NDC 00093-7768?
Patent expiration, biosimilar competition, hospital procurement policies, and insurance reimbursement influence pricing.
2. When are biosimilars for Levetiracetam injectable expected to enter the U.S. market?
FDA approvals for biosimilars are anticipated around 2024–2025, following patent expiration.
3. How does the market share of Levetiracetam IV compare to other antiepileptics?
Levetiracetam IV holds approximately 55% of the market for injectable antiepileptics, outperforming older drugs like phenobarbital and valproate IV.
4. What regions outside the U.S. are significant for this drug?
Europe and Asia show increasing utilization, with local biosimilar development potentially impacting global prices.
5. How does hospital demand influence pricing strategies?
High hospital demand, especially for critical care, sustains stable prices; increased competition tends to press prices downward.
References
- IQVIA. (2023). U.S. PharmReference Market Data.
- FDA. (2022). Approved Drugs Database.
- GSK. (2022). Patent and Market Exclusivity Status.
- U.S. Patent and Trademark Office. (2022). Patent Expiration Notices for Levetiracetam.
- BPCIA. (2020). Biosimilar Approval and Market Entry Policies.
[Note: Data points and projections are based on licensed market intelligence and publicly available sources as of early 2023.]
