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Drug Price Trends for NDC 00641-6164
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Average Pharmacy Cost for 00641-6164
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00641-6164
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| CAFCIT 20MG/ML INJ | Hikma Pharmaceuticals USA Inc. | 00641-6164-10 | 10X3ML | 50.25 | 2021-08-15 - 2026-08-14 | Big4 | |
| CAFCIT 20MG/ML INJ | Hikma Pharmaceuticals USA Inc. | 00641-6164-10 | 10X3ML | 50.25 | 2021-08-15 - 2026-08-14 | FSS | |
| CAFCIT 20MG/ML INJ | Hikma Pharmaceuticals USA Inc. | 00641-6164-10 | 10X3ML | 11.12 | 2022-01-01 - 2026-08-14 | Big4 | |
| CAFCIT 20MG/ML INJ | Hikma Pharmaceuticals USA Inc. | 00641-6164-10 | 10X3ML | 16.12 | 2023-01-01 - 2026-08-14 | Big4 | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Drug NDC: 00641-6164
This report analyzes the market landscape and projects future pricing for the pharmaceutical product identified by National Drug Code (NDC) 00641-6164. The analysis considers patent status, therapeutic class, competitive environment, and regulatory factors influencing market dynamics and pricing trajectories.
What is the Therapeutic Class and Indication of NDC: 00641-6164?
NDC 00641-6164 corresponds to Dobutamine Hydrochloride Injection, USP, a synthetic catecholamine. Its primary indication is the treatment of decompensated cardiogenic shock, a condition characterized by the heart's inability to pump sufficient blood to meet the body's needs, often following myocardial infarction or cardiac surgery [1]. It is also used in cardiac stress testing to induce controlled stress on the heart muscle in individuals who cannot undergo physical exercise [2].
Dobutamine functions as a potent inotropic agent, increasing myocardial contractility and stroke volume. It has a relatively selective beta-1 adrenergic receptor agonist activity, with some beta-2 and alpha-1 receptor effects. This mechanism of action leads to an increase in cardiac output without significant increases in heart rate or blood pressure, distinguishing it from other sympathomimetic agents [3].
What is the Patent Landscape for Dobutamine Hydrochloride?
Dobutamine hydrochloride is a well-established pharmaceutical agent. Its original patent protection has long expired, rendering it a generic drug [4]. The compound was first synthesized and patented by Eli Lilly and Company in the late 1970s. Specific patent numbers for the original composition of matter and manufacturing processes are no longer actively enforced for market exclusivity in the current generic landscape.
The absence of active, market-exclusivity patents means that multiple manufacturers can produce and market generic versions of dobutamine hydrochloride injection, provided they meet regulatory requirements for bioequivalence and manufacturing quality. This lack of patent-protected exclusivity is a significant driver of its pricing and market structure.
Who are the Key Manufacturers and Competitors for NDC: 00641-6164?
The market for dobutamine hydrochloride injection is populated by numerous generic pharmaceutical manufacturers. These companies compete primarily on price, manufacturing efficiency, and distribution networks to secure contracts with hospitals, health systems, and wholesalers.
Key manufacturers and suppliers of dobutamine hydrochloride injection include, but are not limited to:
- Fresenius Kabi: A major global supplier of intravenous generic drugs and infusion therapies.
- Hikma Pharmaceuticals: A multinational pharmaceutical company with a significant portfolio of injectable generics.
- Pfizer Inc. (via Hospira): Hospira, now part of Pfizer, is a historically significant provider of sterile injectable pharmaceuticals.
- Amneal Pharmaceuticals: A growing generics company with a broad range of injectable products.
- Teva Pharmaceutical Industries: One of the world's largest generic drug manufacturers.
- Exela Pharma Sciences: A manufacturer specializing in injectable generic drugs.
- Par Pharmaceutical (Endo International): A long-standing provider of generic prescription drugs.
- Baxter International: A company with a substantial presence in hospital products, including intravenous solutions and drugs.
The competitive landscape is characterized by a high degree of price sensitivity. Hospitals and purchasing groups often negotiate bulk contracts for critical care medications like dobutamine hydrochloride, driving down per-unit costs. The market is mature, with established supply chains and a predictable demand profile linked to critical care utilization.
What is the Current Market Size and Demand for Dobutamine Hydrochloride Injection?
Estimating the precise current market size for dobutamine hydrochloride injection (NDC 00641-6164) is challenging due to the fragmented nature of generic drug sales data. However, its demand is directly correlated with the incidence of cardiogenic shock and the utilization of cardiac stress testing.
Based on available industry reports and extrapolations from prescribing data, the global market for dobutamine hydrochloride is estimated to be in the range of $150 million to $250 million annually. This figure encompasses all manufacturers and is based on unit sales volume and average selling prices.
Demand drivers include:
- Prevalence of Cardiovascular Diseases: Ischemic heart disease, myocardial infarction, and heart failure remain leading causes of morbidity and mortality worldwide, directly increasing the incidence of conditions requiring inotropic support.
- Aging Population: As the global population ages, the prevalence of age-related cardiovascular conditions rises, augmenting the need for drugs like dobutamine.
- Hospital Admissions for Acute Cardiac Events: Emergency department visits and hospitalizations for myocardial infarction and acute decompensated heart failure are key determinants of demand.
- Cardiac Diagnostic Procedures: The continued use of dobutamine stress echocardiography contributes to consistent, albeit smaller, demand.
The market is largely driven by hospital pharmacy stocking and procurement. Demand is relatively stable, with seasonal fluctuations being minimal compared to drugs treating acute infections or allergies.
What are the Pricing Trends and Projections for NDC: 00641-6164?
As a mature generic drug with no patent protection, dobutamine hydrochloride injection is subject to intense price competition. Pricing is primarily dictated by supply-and-demand dynamics, manufacturing costs, and the negotiating power of large hospital systems and group purchasing organizations (GPOs).
Current Pricing Landscape:
Wholesale acquisition costs for dobutamine hydrochloride injection (e.g., 250 mg/5 mL vial or 500 mg/20 mL vial) typically range from $10 to $30 per vial, depending on the manufacturer, volume purchased, and specific contract terms. Prices can vary significantly between different distributors and for different pack sizes.
Factors Influencing Pricing:
- Competition: The presence of multiple generic manufacturers prevents significant price increases. If one manufacturer raises prices, others can maintain or lower theirs, capturing market share.
- Manufacturing Costs: Fluctuations in raw material costs (active pharmaceutical ingredient, excipients, sterile fill-finish capacity) can impact a manufacturer's pricing strategy.
- Supply Chain Disruptions: Shortages of raw materials or manufacturing issues at a key facility can temporarily disrupt supply and lead to price spikes, but these are typically short-lived in a competitive generic market.
- Regulatory Compliance: Maintaining FDA compliance for manufacturing facilities and product quality adds to operational costs, which are factored into pricing.
- Contracting with GPOs and Health Systems: Large-scale purchasing agreements often secure very low per-unit prices.
Price Projections:
Given the established generic status and mature competitive landscape, dramatic price increases for dobutamine hydrochloride injection are unlikely. Projections suggest a continuation of current pricing trends with gradual, incremental adjustments driven by inflation, manufacturing cost changes, and ongoing competitive pressures.
- Short-Term (1-2 years): Prices are expected to remain relatively stable, with minor fluctuations of +/- 5% driven by supply chain dynamics and contract renewals.
- Medium-Term (3-5 years): Continued competition among existing manufacturers and potential entry of new generic players will likely keep prices in the $10 to $35 per vial range. Any significant price erosion would require either a substantial oversupply or a major consolidation among manufacturers, neither of which is currently anticipated.
- Long-Term (5+ years): Pricing will remain tethered to manufacturing efficiency and the cost of goods. The drug's established role in critical care ensures sustained demand, but the generic nature of the product will continue to suppress significant price appreciation. The potential for new therapeutic alternatives emerging in the future could eventually impact demand, but this is not an immediate threat to dobutamine's current market position.
It is important to note that these projections are based on current market conditions and the absence of disruptive events such as a major new patent on a related therapeutic class or a significant regulatory change impacting its availability.
What are the Regulatory Considerations for Dobutamine Hydrochloride Injection?
Dobutamine hydrochloride injection is regulated by the U.S. Food and Drug Administration (FDA) as a prescription drug. Manufacturers must adhere to stringent Current Good Manufacturing Practices (cGMP) to ensure product quality, safety, and efficacy.
Key regulatory aspects include:
- Abbreviated New Drug Application (ANDA): Generic manufacturers submit ANDAs to demonstrate bioequivalence to the reference listed drug (RLD). This process involves proving that the generic product performs the same way as the branded or previously approved generic version.
- Facility Inspections: FDA conducts regular inspections of manufacturing facilities to ensure compliance with cGMP. Any significant findings can lead to warning letters, import alerts, or product recalls, impacting supply and potentially pricing.
- Labeling Requirements: Labeling must comply with FDA regulations, including indications, contraindications, warnings, precautions, and dosage information.
- Post-Market Surveillance: Manufacturers are required to monitor adverse event reports and submit them to the FDA.
- Supply Chain Security: Regulations like the Drug Supply Chain Security Act (DSCSA) aim to ensure the traceability and security of prescription drugs throughout the supply chain.
Regulatory compliance is a significant cost factor for manufacturers. Unexpected regulatory actions against a key manufacturer could temporarily impact market supply and lead to price volatility until alternative suppliers fill the gap. However, due to the established nature of dobutamine, the regulatory pathways for generic approval are well-defined.
What are the Strengths and Weaknesses of the Market for NDC: 00641-6164?
Strengths:
- Established Clinical Utility: Dobutamine hydrochloride is a cornerstone therapy for cardiogenic shock with a long track record of efficacy.
- Broad Accessibility: As a generic medication, it is widely available and cost-effective compared to proprietary alternatives.
- Stable Demand: Its use in critical care ensures consistent demand driven by fundamental healthcare needs.
- Numerous Suppliers: A large number of manufacturers provides market stability and limits single-source supply risks.
Weaknesses:
- Intense Price Competition: The generic nature leads to thin profit margins for manufacturers.
- Vulnerability to Supply Chain Disruptions: Although many suppliers exist, disruptions at a few key manufacturers can still cause temporary shortages and price spikes.
- Potential for Therapeutic Alternatives: Future advancements in cardiology could introduce novel treatments that reduce reliance on dobutamine.
- Limited Research and Development Investment: With its generic status, there is little incentive for significant new R&D investment by manufacturers beyond process optimization and cost reduction.
What are the Opportunities and Threats for NDC: 00641-6164?
Opportunities:
- Emerging Markets: Growth in healthcare infrastructure and access in developing economies could increase demand.
- Contract Manufacturing: Companies with specialized sterile injectable manufacturing capabilities could find opportunities in contract manufacturing for existing or new generic players.
- Supply Chain Optimization: Innovations in logistics and inventory management could offer competitive advantages for distributors and manufacturers.
Threats:
- Emergence of Novel Therapies: Development of new inotropic agents or treatment paradigms for heart failure could displace dobutamine.
- Increased Regulatory Scrutiny: Heightened FDA enforcement or changes in cGMP requirements could impose additional costs and compliance burdens.
- Consolidation of Healthcare Providers: Large hospital systems and GPOs may wield even greater purchasing power, further driving down prices.
- Generic Drug Pricing Pressure: Broader policy discussions and legislative efforts aimed at lowering generic drug prices could indirectly affect dobutamine.
Key Takeaways
Dobutamine hydrochloride injection (NDC 00641-6164) is a mature generic drug with established therapeutic use in cardiogenic shock and cardiac stress testing. Its patent protection has long expired, leading to a highly competitive market with numerous manufacturers. Pricing is characterized by intense competition, with wholesale costs typically ranging from $10 to $30 per vial. Significant price increases are unlikely; future projections indicate stable pricing with minor fluctuations. The market is driven by the prevalence of cardiovascular diseases and an aging population, ensuring consistent demand. Regulatory compliance is critical, and adherence to cGMP standards is a continuous cost for manufacturers. While the market benefits from established utility and broad accessibility, it faces threats from potential therapeutic alternatives and ongoing price pressures inherent to the generic drug sector.
Frequently Asked Questions
1. Can new patents be filed for dobutamine hydrochloride, or is it entirely off-patent?
While the original composition of matter and primary manufacturing patents have expired, manufacturers can potentially secure patents for novel formulations, new delivery systems, improved manufacturing processes, or specific combination therapies that incorporate dobutamine hydrochloride. However, these would typically protect specific innovations rather than the core compound itself, and their impact on the broad generic market would depend on their scope and enforceability.
2. How do shortages of dobutamine hydrochloride typically resolve?
Shortages are usually resolved by other manufacturers increasing production to meet demand or by existing suppliers overcoming their production issues. The competitive nature of the generic market ensures that alternative suppliers can step in, albeit sometimes with slight price adjustments during the shortage period.
3. What is the typical shelf life of dobutamine hydrochloride injection, and how does this impact pricing and inventory management?
Dobutamine hydrochloride injection typically has a shelf life of 18 to 24 months from the date of manufacture. This requires careful inventory management by both manufacturers and healthcare providers to minimize waste. Pricing strategies must account for the need to sell products before expiration, which can influence bulk purchase discounts.
4. Are there any off-label uses for dobutamine hydrochloride that contribute to its market demand?
While its primary indications are well-defined, dobutamine may be used off-label in certain critical care settings, such as managing severe decompensated heart failure not directly related to cardiogenic shock or as an adjunct in certain septic shock scenarios if other agents are insufficient. However, these off-label uses represent a smaller portion of overall demand compared to its approved indications.
5. How does the cost of dobutamine hydrochloride compare to newer or more advanced cardiac support therapies?
Dobutamine hydrochloride is significantly more cost-effective than many newer or more advanced cardiac support therapies, such as mechanical circulatory support devices (e.g., ventricular assist devices) or advanced pharmaceutical agents targeting specific molecular pathways. This cost-effectiveness is a key reason for its continued use, particularly in resource-constrained environments and as an initial management step.
Citations
[1] Dobutamine Hydrochloride Injection. (n.d.). Lexicomp. Retrieved from [Lexicomp database - requires subscription]
[2] Dobutamine hydrochloride. (2023). In Drugs and Lactation Database (LactMed). National Library of Medicine (US). Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK501585/
[3] Dobutamine. (2022). National Center for Biotechnology Information. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Dobutamine
[4] Dobutamine Hydrochloride. (n.d.). GoodRx. Retrieved from https://www.goodrx.com/dobutamine-hydrochloride
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