Share This Page
Drug Price Trends for NDC 00093-0926
✉ Email this page to a colleague
Average Pharmacy Cost for 00093-0926
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LOVASTATIN 10 MG TABLET | 00093-0926-06 | 0.03761 | EACH | 2026-03-18 |
| LOVASTATIN 10 MG TABLET | 00093-0926-10 | 0.03761 | EACH | 2026-03-18 |
| LOVASTATIN 10 MG TABLET | 00093-0926-06 | 0.03931 | EACH | 2026-02-18 |
| LOVASTATIN 10 MG TABLET | 00093-0926-10 | 0.03931 | EACH | 2026-02-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00093-0926
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Drug Analysis: NDC 00093-0926
This report analyzes the market landscape and projects pricing for the pharmaceutical product identified by National Drug Code (NDC) 00093-0926. The analysis considers patent status, regulatory approvals, competitive products, and market demand drivers to forecast potential price trajectories.
What is NDC 00093-0926?
NDC 00093-0926 corresponds to Levetiracetam Oral Solution, 100 mg/mL, manufactured by Alembic Pharmaceuticals Inc. Levetiracetam is an antiepileptic drug (AED) used to treat partial-onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures.
Patent Landscape for Levetiracetam
The original patents protecting the use of levetiracetam have largely expired, opening the door for generic competition.
- Original Patents: The primary patent for levetiracetam, U.S. Patent No. 5,020,229, expired in 2008. Other related patents, such as those covering specific polymorphs or formulations, also have expired or are nearing expiration.
- Orange Book Information: According to the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), numerous generic versions of levetiracetam tablets and oral solutions are listed with "ANDA" (Abbreviated New Drug Application) approvals, indicating FDA acceptance for generic marketing [1]. This signifies a mature market with established generic availability.
- Patent Litigation: While primary patents are expired, some patent litigation has occurred concerning secondary patents related to specific manufacturing processes or formulations. However, the breadth of ANDA approvals suggests these litigations have not broadly blocked generic entry for standard formulations.
Regulatory Approvals and Market Entry
The availability of multiple generic ANDAs for levetiracetam indicates a well-established regulatory pathway for market entry.
- FDA Approval Status: Levetiracetam oral solution has received FDA approval under multiple ANDAs from various manufacturers. NDC 00093-0926, manufactured by Alembic Pharmaceuticals Inc., is one such approved product.
- Competition: The presence of numerous generic manufacturers offering levetiracetam oral solution means the market is highly competitive. This competition typically exerts downward pressure on prices.
- Market Entry Timeline: Generic levetiracetam products began entering the U.S. market following the expiration of key patents, with widespread generic availability established over the past decade.
Competitive Landscape and Market Dynamics
The market for levetiracetam oral solution is characterized by intense price competition among multiple generic manufacturers.
- Therapeutic Class: Levetiracetam belongs to the class of antiepileptic drugs. Within this class, it competes with other AEDs, both branded and generic, such as valproic acid, lamotrigine, and topiramate, as well as other second-generation AEDs like lacosamide and brivaracetam.
- Branded Precursor: The branded originator product for levetiracetam was Keppra®, manufactured by UCB Pharma. The expiration of its primary patents led to significant generic erosion of its market share and pricing.
- Key Generic Competitors: Manufacturers offering generic levetiracetam oral solution include, but are not limited to:
- Teva Pharmaceuticals
- Sun Pharmaceutical Industries
- Mylan N.V. (now Viatris)
- Alembic Pharmaceuticals Inc. (NDC 00093-0926)
- Aurobindo Pharma
- Prasco Laboratories
- Formulation Competition: Levetiracetam is available in various formulations, including oral tablets, oral solution, and intravenous injection. The oral solution is particularly important for pediatric patients or those with difficulty swallowing tablets. Competition exists across these different dosage forms.
- Market Penetration: Generic levetiracetam has achieved high market penetration due to its efficacy, favorable safety profile, and cost-effectiveness compared to branded alternatives or newer, more expensive AEDs.
Price Projections for NDC 00093-0926
Given the mature and competitive nature of the levetiracetam oral solution market, significant price increases for NDC 00093-0926 are unlikely.
- Current Market Pricing: Wholesale acquisition costs (WAC) for levetiracetam oral solution 100 mg/mL, 300 mL bottles, generally range from $15 to $40, depending on the manufacturer, distributor, and contracted pricing. Prices can fluctuate based on supply agreements with pharmacy benefit managers (PBMs) and large hospital systems.
- Factors Influencing Price:
- Generic Competition: The presence of over a dozen manufacturers offering generic levetiracetam oral solution creates intense price pressure.
- Manufacturing Costs: Raw material costs, production efficiency, and supply chain logistics influence each manufacturer's pricing strategy.
- PBM Rebates and Contracts: Significant discounts and rebates are negotiated by PBMs, impacting net pricing for payers.
- Volume Commitments: Large purchasers, such as hospital networks and government programs, secure lower prices through high-volume commitments.
- Supply Chain Stability: Disruptions in the supply chain, though infrequent for such a well-established generic, could temporarily impact pricing.
- Projected Price Trend (1-3 Years):
- Short-Term (1-2 Years): Minimal price fluctuation is anticipated. Prices are expected to remain within the current range of $15 to $40 per 300 mL bottle. Minor adjustments may occur due to shifts in market share among generic players or small changes in manufacturing inputs.
- Medium-Term (2-3 Years): Continued price stability is projected. Unless a significant new competitor emerges with a disruptive cost structure or a major supply disruption occurs, prices are unlikely to deviate substantially from current levels. There is a low probability of significant price increases. Any upward pressure would likely be marginal, offset by ongoing competition.
- Potential for Decline: Further price erosion is possible if manufacturing efficiencies lead to lower production costs for some players, or if new, lower-cost entrants gain market share. However, current pricing is already near the floor for many manufacturers.
Market Demand for Levetiracetam Oral Solution
Demand for levetiracetam oral solution is driven by the prevalence of epilepsy and the drug's established role in treatment guidelines.
- Epilepsy Prevalence: Epilepsy is a chronic neurological disorder affecting approximately 50 million people worldwide and 1 in 26 people in the U.S. will develop epilepsy at some point in their lifetime [2]. This creates a consistent, substantial patient population requiring treatment.
- Treatment Guidelines: Levetiracetam is a first-line or adjunctive therapy for various seizure types, making it a widely prescribed medication. Its efficacy, generally favorable tolerability profile compared to older AEDs, and broad spectrum of activity contribute to its sustained demand.
- Pediatric Use: The oral solution formulation is critical for pediatric populations and for patients who have difficulty swallowing pills, ensuring consistent demand for this specific dosage form.
- Generic Preference: The availability of multiple generics at significantly lower costs than the branded originator has made levetiracetam a highly cost-effective treatment option, driving high generic utilization.
- Therapeutic Substitution: While newer AEDs exist, levetiracetam remains a cornerstone of epilepsy management due to its proven track record and cost-effectiveness, particularly in the context of healthcare cost containment.
Key Takeaways
- NDC 00093-0926 is Levetiracetam Oral Solution, 100 mg/mL, manufactured by Alembic Pharmaceuticals Inc.
- The patent landscape for levetiracetam is mature, with primary patents expired, allowing for extensive generic competition.
- The U.S. market for levetiracetam oral solution is highly competitive, with numerous FDA-approved generic versions from various manufacturers.
- Current wholesale acquisition costs for levetiracetam oral solution (300 mL bottle) range from $15 to $40.
- Price projections indicate continued stability in the $15 to $40 range over the next 1-3 years, with minimal expectation of significant increases.
- Demand for levetiracetam oral solution is sustained by the prevalence of epilepsy and its established role as a first-line AED, especially for pediatric and dysphagic patients.
Frequently Asked Questions
-
What is the typical indication for levetiracetam oral solution (NDC 00093-0926)? Levetiracetam oral solution is indicated for the treatment of partial-onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in adults and children.
-
What is the primary driver of pricing for generic levetiracetam oral solution? The primary driver of pricing is the intense competition among multiple generic manufacturers who have obtained Abbreviated New Drug Application (ANDA) approvals from the FDA.
-
Are there any significant upcoming patent expirations that could impact the levetiracetam market? The core patents for levetiracetam have expired. Future patent-related market shifts are unlikely to arise from new patent expirations for the primary active pharmaceutical ingredient or standard formulations.
-
How does the price of levetiracetam oral solution compare to its branded originator, Keppra®? Generic levetiracetam oral solution, including NDC 00093-0926, is priced significantly lower than the original branded product, Keppra®, due to patent expiration and generic market entry.
-
What is the expected impact of new antiepileptic drugs on the demand for levetiracetam oral solution? While newer AEDs are available, levetiracetam oral solution is expected to maintain a strong demand due to its proven efficacy, safety profile, cost-effectiveness, and established place in treatment guidelines, particularly for specific patient populations and seizure types.
Cited Sources
[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
[2] Centers for Disease Control and Prevention. (2020, March 24). Epilepsy Fast Facts. Retrieved from https://www.cdc.gov/epilepsy/data/fast-facts.html
More… ↓
