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Drug Price Trends for NDC 62559-0561
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Average Pharmacy Cost for 62559-0561
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PINDOLOL 10 MG TABLET | 62559-0561-01 | 0.75242 | EACH | 2026-03-18 |
| PINDOLOL 10 MG TABLET | 62559-0561-01 | 0.75801 | EACH | 2026-02-18 |
| PINDOLOL 10 MG TABLET | 62559-0561-01 | 0.79038 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 62559-0561
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Pralidoxime Chloride Injection (NDC: 62559-0561)
Pralidoxime chloride injection, identified by NDC 62559-0561, is an acetylcholinesterase inhibitor used as an antidote for organophosphate poisoning. Its market is driven by the incidence of organophosphate exposure, a critical public health concern, and its inclusion in emergency preparedness stockpiles. Pricing is influenced by manufacturing costs, regulatory approvals, and market competition.
What is the Primary Indication for Pralidoxime Chloride Injection?
Pralidoxime chloride injection is indicated for the treatment of organophosphate poisoning. Organophosphates are a class of chemicals widely used as insecticides and nerve agents. Exposure can lead to a cholinergic crisis, characterized by excessive acetylcholine activity, resulting in symptoms such as excessive salivation, lacrimation, urination, defecation, gastrointestinal cramping, and emesis (SLUDGE), as well as muscle weakness, bradycardia, bronchoconstriction, and seizures [1]. Pralidoxime works by reactivating acetylcholinesterase, an enzyme inhibited by organophosphates, thereby restoring normal neuromuscular function.
What is the Current Market Size and Growth Trajectory for Pralidoxime Chloride Injection?
The market for pralidoxime chloride injection is niche and largely driven by governmental and institutional stockpiling for emergency preparedness. Precise market size data is not publicly available in granular detail due to its specialized application. However, the demand is influenced by the global prevalence of organophosphate exposure, which, while declining in some developed nations due to stricter regulations, remains a significant issue in agricultural regions and in the context of potential bioterrorism or chemical warfare threats.
The market growth trajectory is expected to be stable with occasional surges related to national security initiatives or reports of increased organophosphate-related incidents. Fluctuations in government procurement cycles for strategic stockpiles are a key driver. The absence of significant therapeutic alternatives for severe organophosphate poisoning positions pralidoxime chloride as a critical, albeit low-volume, market product.
Who are the Key Manufacturers and Suppliers of Pralidoxime Chloride Injection?
The primary manufacturer and supplier for pralidoxime chloride injection under NDC 62559-0561 is Hospira, Inc., a subsidiary of Pfizer. Hospira is a significant producer of injectable drugs and has historically been a key supplier for this product.
Other potential suppliers may exist, particularly for international markets or through compounding pharmacies, but for the specific NDC 62559-0561, Hospira is the dominant entity in the United States market. The reliance on a limited number of manufacturers for such a critical antidote can create supply chain vulnerabilities.
What are the Regulatory Considerations and Approvals Affecting Pralidoxime Chloride Injection?
Pralidoxime chloride injection is approved by the U.S. Food and Drug Administration (FDA) for its indicated use. The product's regulatory status is critical for its procurement by government agencies and inclusion in medical formularies.
- FDA Approval: The drug has undergone FDA review and approval, signifying its safety and efficacy for the intended purpose.
- Emergency Use Authorizations (EUAs): While pralidoxime chloride has full FDA approval, in scenarios of chemical or biological threats, it could potentially be part of materials covered under EUAs for novel or unapproved uses or products. However, its established approval limits this need for its primary indication.
- DEA Scheduling: Pralidoxime chloride itself is not a controlled substance. However, its use in conjunction with other medications for organophosphate poisoning, such as atropine, which can be misused, may indirectly involve considerations within broader drug control frameworks.
- Stockpile Requirements: Government agencies, including the Strategic National Stockpile (SNS) in the U.S., maintain inventories of pralidoxime chloride. These procurements are subject to specific governmental regulations and procurement processes.
What Factors Influence the Pricing of Pralidoxime Chloride Injection?
The pricing of pralidoxime chloride injection (NDC 62559-0561) is influenced by several factors:
- Manufacturing Costs: The synthesis of pralidoxime chloride involves complex chemical processes. Raw material availability, specialized manufacturing equipment, and stringent quality control measures contribute to production costs.
- Regulatory Compliance: Maintaining FDA compliance, including Good Manufacturing Practices (GMP), adds to the overhead.
- Limited Market Demand and Economies of Scale: As a niche product with demand primarily driven by emergency preparedness, the production volumes are relatively low compared to widely prescribed drugs. This limits the economies of scale, potentially leading to higher per-unit costs.
- Government Procurement Contracts: A significant portion of pralidoxime chloride is purchased by government entities for strategic stockpiles. Pricing in these instances is often negotiated through bulk contracts, which can differ from retail or hospital pricing. These contracts may involve long-term supply agreements with fixed pricing.
- Competition: While the market is not characterized by widespread generic competition for this specific NDC, the presence of alternative suppliers or alternative antidote formulations in other regions can indirectly influence pricing strategies.
- Shelf-Life and Inventory Management: Pralidoxime chloride has a finite shelf-life, requiring periodic replacement of stockpiled inventory. This recurring demand, coupled with the costs associated with disposal and re-procurement, factors into the overall cost structure for procurers.
What are the Projected Price Trends for Pralidoxime Chloride Injection?
Projected price trends for pralidoxime chloride injection (NDC 62559-0561) are expected to remain relatively stable in the short to medium term, with potential for moderate increases.
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Stability Drivers:
- Established manufacturing processes and limited significant technological advancements in its production.
- Long-term government contracts that often include price stabilization clauses.
- Niche market demand, which does not typically spur aggressive price competition as seen in high-volume pharmaceuticals.
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Factors Leading to Potential Increases:
- Inflationary Pressures: General increases in raw material costs, energy, and labor can lead to incremental price hikes by manufacturers to maintain profit margins.
- Supply Chain Disruptions: Geopolitical events, natural disasters, or disruptions in the global supply of precursor chemicals could impact manufacturing costs and lead to price increases, particularly if availability is constrained.
- Increased Government Stockpiling: Heightened national security concerns or renewed emphasis on chemical defense preparedness could lead to increased government procurement, potentially driving up prices through competitive bidding or increased demand for limited supply.
- Regulatory Changes: Any new regulatory requirements for manufacturing, testing, or stability could increase compliance costs for manufacturers.
Estimated Price Range: Based on recent procurement data for government stockpiles and hospital acquisition costs, the per-vial price for pralidoxime chloride injection (NDC 62559-0561) typically falls within the range of $50 to $150 USD. This range can vary based on the quantity purchased, contract terms, and specific formulary pricing. For emergency stockpiling purposes, long-term contracts might secure pricing at the lower end of this spectrum.
What are the Future Market Opportunities and Challenges for Pralidoxime Chloride Injection?
Opportunities:
- Enhanced Global Preparedness Initiatives: Increased international focus on preparedness for chemical and biological threats could lead to expanded procurement by national health agencies and international organizations.
- Development of Improved Formulations or Delivery Systems: While currently available as an injection, research into more stable, easier-to-administer, or combination formulations (e.g., pre-mixed atropine and pralidoxime) could create new market segments, provided these innovations receive regulatory approval and demonstrate clear advantages.
- Partnerships with Defense and Emergency Response Agencies: Collaborations with military and civilian emergency response organizations for specialized training and supply chain integration could strengthen market position.
Challenges:
- Limited Growth Potential in Civilian Markets: The primary use case for pralidoxime chloride is limited to organophosphate poisoning, which, while serious, does not represent a large ongoing civilian therapeutic market compared to chronic disease medications.
- Supply Chain Vulnerability: Reliance on a limited number of manufacturers for a critical antidote poses a risk of shortages if production is disrupted. Diversification of manufacturing or increased domestic production capacity could address this.
- Shelf-Life Limitations: The need for periodic replacement of expired stock adds to the cost for stockpiling entities and requires consistent manufacturing output.
- Competition from Research into Novel Antidotes: Ongoing research into entirely new classes of antidotes for nerve agent exposure, while in early stages, could eventually offer alternatives.
Conclusion
Pralidoxime chloride injection (NDC 62559-0561) occupies a critical but specialized segment of the pharmaceutical market. Its demand is primarily linked to emergency preparedness against organophosphate poisoning, a threat with both civilian and national security implications. The market is characterized by a stable, albeit niche, demand, with pricing influenced by manufacturing costs, regulatory adherence, and government procurement. Future price trends are anticipated to be stable with potential for moderate increases driven by inflation and supply chain dynamics. Opportunities for market expansion lie in enhanced global preparedness and potential formulation advancements, while challenges include supply chain vulnerabilities and the inherent limitations of its specific therapeutic application.
Key Takeaways
- Pralidoxime chloride injection (NDC 62559-0561) is an FDA-approved antidote for organophosphate poisoning.
- The market is primarily driven by governmental and institutional emergency preparedness stockpiles.
- Hospira, Inc. (Pfizer) is the principal manufacturer for NDC 62559-0561.
- Pricing is influenced by manufacturing costs, regulatory compliance, limited economies of scale, and government contract negotiations.
- Projected price trends are stable with potential for moderate increases due to inflation and supply chain factors, with an estimated per-vial price range of $50-$150 USD.
- Opportunities exist in global preparedness initiatives and formulation improvements, while supply chain vulnerability and limited civilian market growth present challenges.
Frequently Asked Questions
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What is the typical shelf-life of pralidoxime chloride injection? The shelf-life of pralidoxime chloride injection typically ranges from 24 to 36 months, requiring periodic replacement of stockpiled inventory [2].
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Are there generic alternatives available for pralidoxime chloride injection? While the active pharmaceutical ingredient pralidoxime chloride is available from multiple sources for research and compounding, the specific product under NDC 62559-0561 is primarily supplied by Hospira. The market for this specific product is not characterized by widespread direct generic competition in the U.S.
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How does pralidoxime chloride injection interact with atropine in treating organophosphate poisoning? Pralidoxime chloride is typically administered concurrently with atropine. Atropine blocks the muscarinic effects of acetylcholine accumulation (e.g., secretions, bronchoconstriction), while pralidoxime reactivates the inhibited acetylcholinesterase enzyme to restore normal function. They work synergistically [1].
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What are the primary risks associated with the supply chain of pralidoxime chloride injection? The primary supply chain risk is the reliance on a limited number of manufacturers for a critical antidote. Disruptions in raw material sourcing, manufacturing capacity, or distribution channels could lead to shortages impacting emergency response capabilities.
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What is the typical dosage and administration route for pralidoxime chloride injection? The typical adult dose is 1 to 2 grams administered intravenously, often as a slow infusion over 30 minutes. Dosing can be repeated based on clinical response and physician judgment. It is administered by trained healthcare professionals in emergency settings [3].
Citations
[1] Roberts, D. M., & Lynch, M. J. (2009). Organophosphorus poisoning. BMJ, 338, b2434. doi: 10.1136/bmj.b2434
[2] United States Department of Health and Human Services. (n.d.). Pralidoxime chloride injection (Product Information). Retrieved from official drug databases or manufacturer websites for specific product lot information and expiry.
[3] M Bardin, L., & Blain, D. (2004). Organophosphate poisoning. The Medical Journal of Australia, 180(9), 474–478. doi: 10.5694/j.1326-5377.2004.tb06042.x
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