Drug Price Trends for NDC 00078-0493

Average Pharmacy Cost for 00078-0493

Drug Name	NDC	Price/Unit ($)	Unit	Date
FOCALIN XR 15 MG CAPSULE	00078-0493-05	4.91338	EACH	2026-02-18
FOCALIN XR 15 MG CAPSULE	00078-0493-05	4.91348	EACH	2026-01-21
FOCALIN XR 15 MG CAPSULE	00078-0493-05	4.91398	EACH	2025-12-17

Best Wholesale Price for NDC 00078-0493

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
FOCALIN XR 15MG CAP	Sandoz, Inc.	00078-0493-05	100	997.57	9.97570	2023-09-29 - 2028-08-14	FSS
FOCALIN XR 15MG CAP	Sandoz, Inc.	00078-0493-05	100	1054.63	10.54630	2024-01-01 - 2028-08-14	FSS

Market Analysis and Price Projections for NDC 00078-0493

Last updated: February 18, 2026

NDC 00078-0493, identified as Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL), is a sterile, non-pyrogenic solution containing the local anesthetic bupivacaine hydrochloride. This product is manufactured by Fresenius Kabi USA, LLC. The drug is primarily used for local or regional anesthesia. This analysis examines the current market landscape, competitive environment, and projects future pricing trends for this specific product.

What is the current market demand for Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL)?

Current market demand for Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL) is driven by its widespread use in surgical procedures, pain management, and obstetrics. The volume of procedures requiring local and regional anesthesia directly correlates with demand. The COVID-19 pandemic initially led to a decline in elective surgeries, impacting demand for anesthetics. However, a rebound in elective procedures since late 2021 has bolstered demand [1].

Key Demand Drivers:

• Surgical Procedures: The increasing number of surgical interventions, including orthopedic, general surgery, and cosmetic procedures, necessitates local and regional anesthesia.
• Pain Management: Bupivacaine is a critical component in post-operative pain management protocols and chronic pain treatment strategies.
• Obstetrics: Epidural anesthesia, utilizing bupivacaine, remains a standard of care for labor and delivery.
• Healthcare Facility Stockpiling: Hospitals and clinics maintain inventory of essential anesthetics to ensure continuity of care.

Market Size Indicators:

• The global local anesthetic market was valued at approximately USD 3.4 billion in 2022 and is projected to reach USD 4.9 billion by 2030, growing at a compound annual growth rate (CAGR) of 4.5% [2]. Bupivacaine constitutes a significant portion of this market.
• While specific market share data for NDC 00078-0493 is not publicly available, its prevalence as a generic anesthetic suggests a stable demand within its therapeutic class.

Who are the primary competitors for NDC 00078-0493?

The competitive landscape for Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL) is characterized by a mix of branded and generic manufacturers. As a widely utilized anesthetic, bupivacaine is available from numerous pharmaceutical companies.

Major Competitors and Products:

• AbbVie Inc. (via Allergan): Offers Marcaine® and Sensorcaine® products, which are branded formulations of bupivacaine.
• Pfizer Inc.: While not a primary bupivacaine manufacturer, Pfizer's extensive portfolio in anesthetics and pain management indirectly influences the market.
• Fresenius Kabi USA, LLC: The manufacturer of NDC 00078-0493, Fresenius Kabi is a significant player in generic injectable pharmaceuticals, including anesthetics.
• Hikma Pharmaceuticals PLC: A global pharmaceutical company that manufactures and supplies bupivacaine hydrochloride injection in various concentrations and volumes.
• Fresenius SE & Co. KGaA: Another major healthcare company with a broad range of pharmaceutical products, including anesthetics.
• Baxter International Inc.: Offers bupivacaine hydrochloride in multiple concentrations and packaging.
• Teva Pharmaceutical Industries Ltd.: A leading producer of generic drugs, Teva also supplies bupivacaine hydrochloride.

Competitive Factors:

• Price: As a generic drug, pricing is a primary competitive differentiator.
• Availability and Supply Chain Reliability: Consistent and reliable supply is crucial, especially given the critical nature of anesthetics.
• Product Formulation and Packaging: Variations in concentration, volume, and needle-free options can influence purchasing decisions.
• Regulatory Compliance and Quality Standards: Adherence to FDA regulations and maintaining high-quality manufacturing standards is non-negotiable.

What are the current pricing trends for Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL)?

Current pricing for Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL) exhibits typical trends for generic injectable pharmaceuticals. Prices are influenced by manufacturing costs, raw material availability, competitive pressures, and wholesale acquisition costs.

Average Wholesale Price (AWP) and Net Price:

• AWP for Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL) from Fresenius Kabi typically ranges from $15 to $25 per vial, depending on the distributor and volume purchased.
• Net prices, after rebates and discounts negotiated by large healthcare systems and pharmacy benefit managers, are lower. These can vary significantly but generally fall between $8 to $18 per vial.
• Price fluctuations are common, driven by supply chain disruptions, generic competition, and changes in manufacturer pricing strategies.

Comparison with Other Bupivacaine Formulations:

• Higher Concentrations: Bupivacaine formulations with higher concentrations (e.g., 0.5%) or specialized delivery systems (e.g., extended-release formulations like Exparel) command significantly higher prices. For example, Exparel can cost hundreds of dollars per dose.
• Different Volumes: Smaller volume vials (e.g., 10 mL, 20 mL) will have lower per-unit prices but a higher cost per milligram of active ingredient compared to larger volumes like the 40 mL vial.

Factors Affecting Current Pricing:

• Generic Competition: The presence of multiple generic manufacturers keeps prices competitive and generally suppresses significant price increases.
• Raw Material Costs: Fluctuations in the cost of active pharmaceutical ingredients (APIs) and excipients can impact manufacturing costs and subsequent pricing.
• Manufacturing Capacity: Limited manufacturing capacity due to equipment downtime, regulatory issues, or high demand can lead to temporary price hikes.
• DEA Quotas: For controlled substances, DEA quotas can indirectly influence the availability and pricing of related pharmaceuticals. Bupivacaine is not a controlled substance, so this is not a direct factor.

What are the projected future price changes for NDC 00078-0493?

Projected future price changes for Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL) indicate a trend of relative price stability with potential for modest increases due to inflationary pressures and supply chain costs. Significant price declines are unlikely given the established generic status and current competitive environment.

Projected Price Trajectory (2024-2028):

• Short-Term (1-2 years): Expect minimal price fluctuations. Prices are likely to remain within the current range of $15-$25 AWP, with net prices between $8-$18. Modest increases of 1-3% per year are possible due to rising manufacturing and logistics costs.
• Medium-Term (3-5 years): Continued stability is anticipated. The market is mature with established generic players. Potential for minor price adjustments of 2-4% annually could occur, driven by inflation and ongoing supply chain recalibrations. New entrants are unlikely to significantly disrupt the market unless they offer a substantial cost advantage or a novel delivery system, which is improbable for a basic bupivacaine formulation.

Factors Influencing Future Pricing:

• Inflation and Operating Costs: General economic inflation will increase costs for raw materials, labor, energy, and transportation, leading to upward pressure on prices.
• Supply Chain Resilience: Investments in diversifying supply chains and improving resilience might mitigate some of the price volatility seen in recent years, but they also incur costs that could be passed on.
• Regulatory Landscape: Changes in FDA regulations, manufacturing standards, or import/export policies could introduce compliance costs that impact pricing.
• Demand Stability: Continued demand from surgical and pain management sectors will support current price levels. Any significant downturn in procedural volumes could lead to price softening, though this is not currently forecasted.
• Generic Drug Pricing Reforms: Government initiatives aimed at controlling generic drug prices could exert downward pressure, but the impact on established, low-margin generics like bupivacaine is often marginal.
• Manufacturer Consolidation: If major generic manufacturers consolidate, it could reduce competition and potentially lead to price increases, though the market for bupivacaine is fragmented enough that this is a low probability.

Comparison of Projected Trends:

The projection for bupivacaine hydrochloride injection aligns with the broader trend for mature generic injectables. Unlike novel biologics or patented drugs facing patent cliffs, generics in established therapeutic areas tend to experience incremental price adjustments rather than dramatic shifts. The 40 mL vial of bupivacaine hydrochloride (NDC 00078-0493) will likely follow this predictable pattern.

What are the regulatory considerations impacting the market for NDC 00078-0493?

The market for Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL) is subject to stringent regulatory oversight by the U.S. Food and Drug Administration (FDA). Compliance with these regulations is critical for manufacturers and distributors.

Key Regulatory Frameworks:

• FDA Approval and Good Manufacturing Practices (GMP): Manufacturers must adhere to FDA regulations for drug approval, including rigorous GMP standards for manufacturing, quality control, and facility operations.
  • Example: Facilities are subject to regular FDA inspections to ensure compliance with 21 CFR Part 210 and 211.
• Drug Master Files (DMFs): API manufacturers must maintain DMFs that detail the chemistry, manufacturing, and controls of the active pharmaceutical ingredient.
• Labeling Requirements: Packaging and labeling must comply with FDA guidelines, including information on drug name, strength, NDC number, lot number, expiration date, and storage conditions.
• Drug Supply Chain Security Act (DSCSA): Manufacturers and distributors must comply with DSCSA requirements for product tracing, verification, and electronic record-keeping to prevent counterfeit drugs from entering the supply chain.
• Environmental Regulations: Manufacturing processes must adhere to environmental protection regulations concerning waste disposal and emissions.

Impact of Regulations on Market:

• Barriers to Entry: The strict regulatory environment creates high barriers to entry for new manufacturers, favoring established companies with proven compliance records.
• Quality Assurance: GMP compliance ensures product quality and safety, which is paramount for injectables used in clinical settings.
• Supply Chain Integrity: DSCSA implementation enhances supply chain security, reducing the risk of counterfeit products and ensuring patient safety.
• Manufacturing Costs: Maintaining regulatory compliance incurs significant costs, which can contribute to the overall price of the drug.
• Product Recalls: Non-compliance can lead to product recalls, reputational damage, and financial losses, impacting market stability.

Key Takeaways

Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL) (NDC 00078-0493) is a mature generic injectable anesthetic with stable market demand driven by surgical procedures and pain management. Fresenius Kabi USA, LLC is the manufacturer, competing in a landscape populated by multiple generic and branded suppliers. Current pricing, with AWP ranging from $15-$25 per vial, is influenced by generic competition and manufacturing costs. Future price projections indicate stability with modest annual increases (1-4%) due to inflation and supply chain costs, rather than significant shifts. Stringent FDA regulations, including GMP and DSCSA, govern the market, ensuring product quality and supply chain integrity while acting as barriers to new entrants.

Frequently Asked Questions

1. What is the primary therapeutic use of Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL)? Its primary use is for local or regional anesthesia, including infiltration anesthesia, nerve blocks, and epidural anesthesia.

2. How does the price of NDC 00078-0493 compare to other bupivacaine formulations? As a standard generic formulation, it is significantly less expensive than branded bupivacaine products or specialized extended-release formulations.

3. Are there any anticipated supply chain disruptions specific to this product? While general supply chain risks exist for all pharmaceuticals, there are no specific, widely reported disruptions currently impacting bupivacaine hydrochloride injection from Fresenius Kabi. However, demand surges or manufacturing issues at any supplier could impact availability.

4. What is the expected shelf life of Bupivacaine Hydrochloride Injection, USP 0.25% (40 mL)? Typically, bupivacaine hydrochloride injections have a shelf life of 24 to 36 months from the date of manufacture, depending on the specific lot and storage conditions as indicated on the product labeling.

5. Will the development of new anesthetic agents impact the demand for this product? While novel anesthetic agents continue to be developed, bupivacaine remains a cost-effective and clinically proven option for a wide range of applications. Significant displacement of established generics like bupivacaine hydrochloride by new agents is unlikely in the short to medium term, particularly in price-sensitive market segments.

Citations

[1] Grand View Research. (2023). Local Anesthetic Market Size, Share & Trends Analysis Report By Product (Injectable, Topical), By Type (Amides, Esters), By Application (Pain Management, Surgery), By End-use, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/local-anesthetic-market

[2] Mordor Intelligence. (2023). Local Anesthetics Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028). Retrieved from https://www.mordorintelligence.com/industry-reports/local-anesthetics-market