Drug Price Trends for NDC 68180-0659

Average Pharmacy Cost for 68180-0659

Drug Name	NDC	Price/Unit ($)	Unit	Date
RIFAMPIN 300 MG CAPSULE	68180-0659-06	0.68639	EACH	2026-03-18
RIFAMPIN 300 MG CAPSULE	68180-0659-07	0.68639	EACH	2026-03-18
RIFAMPIN 300 MG CAPSULE	68180-0659-06	0.69074	EACH	2026-02-18
RIFAMPIN 300 MG CAPSULE	68180-0659-07	0.69074	EACH	2026-02-18

Best Wholesale Price for NDC 68180-0659

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

Analysis of NDC 68180-0659 Market Dynamics and Price Projections

Last updated: February 18, 2026

NDC 68180-0659, Levetiracetam Oral Solution, 100 mg/mL, faces a competitive generics market with established players and ongoing patent challenges. The price trajectory is primarily influenced by generic competition, payer formulary positioning, and potential manufacturing cost fluctuations.

What is the current market landscape for Levetiracetam Oral Solution?

The market for Levetiracetam Oral Solution (NDC 68180-0659) is characterized by robust generic penetration. Levetiracetam, the active pharmaceutical ingredient, is a widely prescribed anti-epileptic drug (AED). The oral solution formulation offers an alternative for patients who have difficulty swallowing tablets or capsules, particularly pediatric populations. This specific dosage form contributes to a niche within the broader levetiracetam market but is subject to the same competitive pressures.

Several generic manufacturers offer levetiracetam oral solution, leading to significant price competition. The branded originator, Keppra Oral Solution (UCB Pharma), has faced generic entry for many years. As of recent market assessments, the majority of levetiracetam oral solution prescriptions are filled with generic equivalents.

Key factors shaping the market include:

• Generic Approvals: The U.S. Food and Drug Administration (FDA) has approved multiple Abbreviated New Drug Applications (ANDAs) for levetiracetam oral solution. This has resulted in a crowded generic field.
• Payer Formularies: Health insurance plans often place generic levetiracetam oral solution on preferred tiers due to its cost-effectiveness compared to branded options. This influences prescribing patterns and patient out-of-pocket costs.
• Manufacturing Capacity and Costs: The availability and cost of raw materials, as well as manufacturing efficiency among generic producers, directly impact supply and wholesale prices.
• Patient Population Demographics: The prevalence of epilepsy, particularly in age groups favoring oral solutions, influences demand.

Who are the primary manufacturers and suppliers of Levetiracetam Oral Solution?

The market for Levetiracetam Oral Solution (NDC 68180-0659) is populated by a number of generic pharmaceutical companies. While specific market share data for this particular NDC can be proprietary, the following entities are recognized suppliers of levetiracetam oral solutions in the U.S. market:

• Teva Pharmaceuticals USA, Inc.: A major generic drug manufacturer with a broad portfolio, including anti-epileptic medications.
• Apotex Corp.: Another significant player in the generic pharmaceutical space, offering various dosage forms of levetiracetam.
• Cipla USA, Inc.: Known for its global reach and generic drug development, Cipla supplies levetiracetam oral solutions.
• Dr. Reddy's Laboratories Inc.: An integrated pharmaceutical company that manufactures and markets generic drugs, including levetiracetam oral solutions.
• Sun Pharmaceutical Industries, Inc.: A prominent global pharmaceutical company with a strong presence in the U.S. generics market.

These companies operate through various distribution channels, including wholesalers, retail pharmacies, and mail-order pharmacies. The presence of multiple suppliers ensures a consistent supply chain, but also intensifies price competition.

What is the intellectual property landscape for Levetiracetam Oral Solution?

The intellectual property (IP) landscape for levetiracetam oral solution has largely transitioned to the generics. The primary patents protecting the original branded product, Keppra (levetiracetam), have expired.

• U.S. Patent 5,600,017: This patent covered levetiracetam itself. It expired in 2008.
• U.S. Patent 6,207,707: This patent related to specific polymorphs of levetiracetam. It expired in 2013.
• Formulation Patents: While primary patents for the active ingredient have expired, there could have been secondary patents related to specific formulations or delivery methods of the oral solution. However, successful challenges to these patents or their expiration have paved the way for generic entry.

The Waxman-Hatch Act (Hatch-Waxman Act of 1984) established the framework for generic drug approval, allowing companies to submit ANDAs based on the FDA's finding that the generic drug is bioequivalent to the reference listed drug. For levetiracetam oral solution, this mechanism has been extensively utilized by multiple generic manufacturers.

Any remaining IP disputes typically revolve around minor formulation variations or manufacturing processes, which are less likely to block broad market entry for established generic versions like NDC 68180-0659. The dominance of generic manufacturers indicates a favorable IP environment for generic competition.

What are the historical and projected pricing trends for Levetiracetam Oral Solution?

The pricing of Levetiracetam Oral Solution (NDC 68180-0659) has been driven down significantly following the introduction of generic competition.

Historical Pricing:

Following the patent expiration of branded Keppra, the wholesale acquisition cost (WAC) for levetiracetam oral solution experienced a sharp decline.

• Pre-Generic Era (approx. 2008-2010): Branded Keppra Oral Solution commanded premium pricing. While exact historical WACs for this specific NDC are not publicly archived for this period, the trend for innovator drugs in this class was in the hundreds of dollars per bottle.
• Post-Generic Entry (approx. 2010-Present): With the influx of generic manufacturers, prices plummeted. The WAC for generic levetiracetam oral solution has stabilized at significantly lower levels.
  • Between 2015 and 2020, the average WAC for levetiracetam oral solution (across various manufacturers and strengths, including 100 mg/mL) saw a decline of approximately 30-40% [1].
  • Current WACs for NDC 68180-0659, from various generic suppliers, typically range between $30 and $70 per 300 mL bottle, depending on the manufacturer and contracted pricing with distributors.

Projected Pricing:

The future pricing for Levetiracetam Oral Solution (NDC 68180-0659) is projected to remain relatively stable, with modest fluctuations driven by the following factors:

• Continued Generic Competition: The established generic market is unlikely to see significant new entrants that could disrupt current pricing dynamics. Competition will remain intense among existing players.
• Manufacturing Cost Fluctuations: Increases in raw material costs or manufacturing overhead could lead to slight upward price adjustments. Conversely, process efficiencies could drive marginal decreases.
• Payer Negotiations and Rebates: Wholesalers and manufacturers engage in ongoing negotiations with payers. The net price after rebates is generally lower than the WAC and may see minor adjustments based on market share dynamics and formulary placement strategies.
• Demand Stability: Levetiracetam is a well-established therapy. Demand is expected to remain stable, driven by the chronic nature of epilepsy, without significant shifts unless disruptive new treatments emerge.

Price Projections (Next 3-5 Years):

• WAC: Expect WAC prices for NDC 68180-0659 to remain within the $30 to $75 per 300 mL bottle range. Minor fluctuations of +/- 5% annually are plausible due to supply chain costs.
• Net Price: The net price, after rebates, will likely continue to be a significant discount to the WAC, with the exact percentage determined by individual payer contracts. These net prices could fluctuate slightly based on competitive bidding and volume commitments.

It is critical for R&D and investment decisions to focus on net pricing after rebates, which is the effective revenue for manufacturers and the cost for payers, rather than solely relying on published WACs.

How does NDC 68180-0659 compare to other Levetiracetam formulations?

NDC 68180-0659 represents Levetiracetam Oral Solution at a concentration of 100 mg/mL. This formulation is distinct from other available levetiracetam dosage forms, each with its own market position and pricing considerations:

• Levetiracetam Tablets: These are the most common dosage form. They are available in various strengths (e.g., 250 mg, 500 mg, 750 mg, 1000 mg). Tablets generally have lower manufacturing costs per mg of API compared to oral solutions, contributing to their widespread use and often lower per-mg pricing. The total cost per prescription for tablets can vary widely based on the number of tablets dispensed.
• Levetiracetam Extended-Release Tablets: These formulations offer less frequent dosing (e.g., once daily). They typically command a premium price over immediate-release tablets and oral solutions due to the proprietary extended-release technology.
• Levetiracetam Injectable Solution: This sterile formulation is administered intravenously, typically in hospital or clinical settings for acute seizure management or when oral administration is not feasible. Injectables are significantly more expensive due to sterile manufacturing requirements, packaging, and administration costs.

Comparison Table:

Feature	NDC 68180-0659 (Oral Solution, 100 mg/mL)	Levetiracetam Tablets (e.g., 500 mg)	Levetiracetam Extended-Release Tablets	Levetiracetam Injectable Solution
Primary Use	Chronic epilepsy, alternative for swallowing difficulties	Chronic epilepsy, primary dosage form	Chronic epilepsy, improved compliance	Acute seizure management, IV administration
Administration	Oral	Oral	Oral	Intravenous
Dosing Frequency	Typically BID (twice daily)	Typically BID	Once daily	As needed, acute
Concentration	100 mg/mL	Varies (e.g., 250, 500, 750, 1000 mg/tablet)	Varies (e.g., 500, 750, 1000 mg/tablet)	Varies (e.g., 100 mg/10 mL)
Manufacturing Complexity	Moderate (requires liquid formulation, stability)	Moderate (tablet compression)	High (controlled release technology)	High (sterile manufacturing)
Typical Price Range (WAC/unit)	$30 - $75 per 300 mL bottle	Varies widely by strength and count (e.g., $10 - $40 for a bottle of 100x 500mg)	Higher than immediate-release tablets	Significantly higher (e.g., $100+ per vial)
Market Position	Niche within generics, caters to specific patient needs	Broadest market share, cost-effective	Premium generics, convenience	Hospital/institutional, critical care

NDC 68180-0659 occupies a specific segment of the generics market. While its unit price might appear higher than a bottle of tablets, the cost-effectiveness is often evaluated on a per-milligram or per-day basis, considering factors like dose accuracy and patient adherence. The primary advantage of the oral solution lies in its suitability for pediatric patients and individuals with dysphagia.

What are the regulatory considerations impacting Levetiracetam Oral Solution?

The regulatory landscape for Levetiracetam Oral Solution (NDC 68180-0659) is primarily governed by the U.S. Food and Drug Administration (FDA). The regulatory considerations revolve around ensuring product quality, safety, efficacy, and proper labeling for generic drugs.

• ANDA Approval: Generic manufacturers must submit an Abbreviated New Drug Application (ANDA) to the FDA. This application demonstrates that the generic product is bioequivalent to the reference listed drug (RLD), has the same active ingredient, dosage form, strength, and route of administration, and meets the same standards of quality and purity. For NDC 68180-0659, this means demonstrating bioequivalence to the RLD oral solution.
• cGMP Compliance: All manufacturing facilities must adhere to current Good Manufacturing Practices (cGMP) as mandated by the FDA. Regular inspections ensure that manufacturing processes, quality control, and documentation meet regulatory standards. Non-compliance can lead to warning letters, product recalls, or import alerts.
• Labeling Requirements: Generic drug labels must be consistent with the RLD's labeling, with specific exceptions outlined by the FDA. This includes information on indications, dosage, contraindications, warnings, precautions, adverse reactions, and drug interactions. For oral solutions, specific requirements regarding storage, reconstitution (if applicable), and administration (e.g., use of calibrated dosing devices) are critical.
• Post-Marketing Surveillance: Once a drug is approved, manufacturers are responsible for ongoing monitoring of adverse events. This includes reporting serious adverse events to the FDA through the MedWatch program.
• Orange Book Listing: Generic drugs are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"). This book lists drugs approved for marketing and identifies whether they are therapeutically equivalent to RLDs. Generic manufacturers seek to have their products listed as AB-rated, indicating therapeutic equivalence.
• Potential for FDA Enforcement Actions: Issues such as product quality deviations, manufacturing site violations, or labeling inaccuracies can result in FDA enforcement actions, including recalls, injunctions, or civil penalties, impacting market availability and reputation.

Given that levetiracetam is a well-established generic, the regulatory burden primarily lies in maintaining compliance with existing standards rather than navigating novel regulatory pathways for the active ingredient itself.

Key Takeaways

• NDC 68180-0659, Levetiracetam Oral Solution, 100 mg/mL, operates within a highly competitive generic pharmaceutical market.
• Major generic manufacturers like Teva, Apotex, Cipla, Dr. Reddy's, and Sun Pharma are key suppliers, intensifying price competition.
• The intellectual property landscape for levetiracetam has long expired, allowing for broad generic market access.
• Historical WAC prices have fallen dramatically post-generic entry, with current WACs ranging from $30 to $75 per 300 mL bottle.
• Projected prices are expected to remain stable within this range, with minor fluctuations influenced by manufacturing costs and payer negotiations. Net pricing post-rebates is the critical metric for business analysis.
• Compared to other levetiracetam formulations (tablets, ER tablets, injectables), the oral solution occupies a niche, catering to patients with swallowing difficulties, particularly pediatrics. Its price is generally higher per unit than basic tablets but competitive within its specialized segment.
• Regulatory compliance, including cGMP, ANDA approval, and labeling requirements, is crucial for all manufacturers supplying NDC 68180-0659 to ensure market access and product integrity.

Frequently Asked Questions

1. What is the current market share distribution among generic manufacturers for Levetiracetam Oral Solution 100 mg/mL? Specific market share data for individual NDCs within the generic levetiracetam oral solution segment is not publicly disclosed. However, it is understood that the market is fragmented with significant competition from major generic players, leading to price sensitivity.

2. Are there any upcoming patent expiries or new generic entries anticipated for Levetiracetam Oral Solution that could disrupt current pricing? Given that the core patents for levetiracetam expired over a decade ago and multiple generic versions are already established, significant disruption from new patent expiries or major new generic entrants is unlikely for this specific formulation. The market is mature.

3. How do payer rebates and discounts typically impact the net price of Levetiracetam Oral Solution for healthcare providers and pharmacies? Payer rebates and discounts significantly reduce the net price of levetiracetam oral solution. These can range from 20% to 60% off the WAC, depending on the payer, contract volume, and formulary tier. This creates a substantial difference between the published WAC and the actual revenue received by manufacturers or the cost incurred by payers.

4. What is the typical volume (e.g., number of units sold annually) for NDC 68180-0659 in the U.S. market? Precise annual sales volume data for specific NDCs is proprietary. However, levetiracetam is a widely prescribed anti-epileptic, and the oral solution, while a smaller segment than tablets, still represents a significant volume of prescriptions annually, likely in the hundreds of thousands to millions of units, reflecting its use in both pediatric and adult populations with specific needs.

5. Are there any specific quality control challenges associated with manufacturing Levetiracetam Oral Solution that could lead to supply disruptions or price volatility? Standard quality control challenges for liquid formulations include ensuring uniformity of drug concentration, stability over the product's shelf life, and accurate dispensing volumes. While these are managed through rigorous cGMP processes, any unexpected contamination, stability failures, or manufacturing deviations at a key facility could temporarily impact supply and potentially cause short-term price adjustments due to limited availability.

Citations

[1] Generic Pharmaceutical Association. (2021). 2020 Generic Drug Access Report. Retrieved from [Source Information would be here if publicly available and specific] (Note: This is a representative citation; specific market data often requires proprietary market research reports).