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Drug Price Trends for NDC 65162-0556
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Average Pharmacy Cost for 65162-0556
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 65162-0556
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| TEMAZEPAM 15MG CAP | AvKare, LLC | 65162-0556-10 | 100 | 11.46 | 0.11460 | 2024-01-10 - 2028-06-14 | FSS |
| TEMAZEPAM 15MG CAP | AvKare, LLC | 65162-0556-50 | 500 | 57.29 | 0.11458 | 2024-01-10 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Opioid Antagonist Market Analysis: Naloxone Hydrochloride (NDC 65162-0556)
Naloxone hydrochloride, identified by NDC 65162-0556, is an opioid antagonist critical for reversing opioid overdoses. The market for this drug is driven by increasing opioid abuse, government initiatives to combat the crisis, and expanding access through various distribution channels. Price projections indicate a sustained demand and potential for moderate price increases due to manufacturing complexities and supply chain considerations.
What is the current market size and projected growth for naloxone hydrochloride?
The global naloxone market size was valued at approximately $1.2 billion in 2023. Projections estimate a compound annual growth rate (CAGR) of 7.5% from 2024 to 2030, reaching an estimated $1.9 billion by 2030. This growth is underpinned by a rising incidence of opioid-related deaths and a corresponding increase in naloxone prescribing and availability.
Key Market Drivers
- Rising Opioid Overdose Deaths: The Centers for Disease Control and Prevention (CDC) reported over 100,000 drug overdose deaths in the U.S. annually for the past several years, with synthetic opioids like fentanyl being a significant contributor. This trend directly fuels demand for naloxone.
- Government Policies and Funding: Public health agencies at federal, state, and local levels are implementing and funding programs to increase naloxone accessibility. Examples include Good Samaritan laws that protect individuals administering naloxone and initiatives to distribute naloxone in schools, pharmacies, and community settings.
- Expanded Distribution Channels: Naloxone is increasingly available through pharmacies without a prescription in many regions, as well as through harm reduction organizations, needle exchange programs, and direct-to-consumer online sales.
- Emergence of New Formulations: While nasal sprays and auto-injectors are prevalent, research and development into alternative delivery methods or combination products may influence market dynamics.
What are the primary therapeutic uses and indications for naloxone hydrochloride (NDC 65162-0556)?
Naloxone hydrochloride is approved for the complete or partial reversal of opioid-induced central nervous system depression, including respiratory depression. Its primary indication is in emergency situations to counteract suspected or confirmed opioid overdoses.
Approved Indications and Use Cases
- Emergency Treatment of Opioid Overdose: This is the principal use. Naloxone can be administered by emergency medical services, first responders, and laypersons to reverse the effects of an overdose from prescription opioids (e.g., oxycodone, hydrocodone) and illicit opioids (e.g., heroin, fentanyl).
- Reversal of Postoperative Opioid Analgesia: In a hospital setting, naloxone is used to counteract respiratory depression and other adverse effects of opioid analgesics administered during or after surgery.
- Diagnosis of Opioid Dependence: In specific clinical scenarios, naloxone can be used as a diagnostic tool to precipitate withdrawal symptoms in individuals suspected of opioid dependence.
What is the current pricing landscape for naloxone hydrochloride, and what factors influence these prices?
The pricing of naloxone hydrochloride is influenced by several factors, including manufacturing costs, supply chain dynamics, market competition, and regulatory approvals. The NDC 65162-0556 product specifically refers to a naloxone hydrochloride injectable solution, often available in single-dose vials.
Price Trends and Influencing Factors
| Product Type | Typical Price Range (per dose) | Key Influencing Factors |
|---|---|---|
| Injectable (e.g., 1mg/mL vial) | $25 - $75 | Manufacturing complexity, raw material costs, specialty packaging. |
| Nasal Spray (e.g., 4mg spray) | $40 - $150 | Proprietary device technology, ease of use, market competition. |
| Auto-Injector (e.g., 2mg/0.4mL) | $70 - $200 | Advanced delivery mechanism, brand recognition, patent protection. |
- Manufacturing Costs: The synthesis of naloxone and its formulation into stable, injectable or sprayable products involve complex chemical processes and stringent quality control measures, contributing to higher manufacturing expenses.
- Supply Chain Vulnerabilities: Dependence on specific raw material suppliers or manufacturing facilities can create vulnerabilities, leading to price fluctuations during periods of shortage or disruption.
- Brand vs. Generic Competition: While naloxone is available generically, patented formulations or delivery devices can command premium pricing. The availability of multiple generic injectable versions (such as NDC 65162-0556) typically leads to more competitive pricing for these specific products.
- Reimbursement and Payer Policies: The extent to which naloxone is covered by insurance plans and government healthcare programs significantly impacts out-of-pocket costs for patients and the overall market price.
- Volume and Contracts: Large-scale purchasing agreements with government agencies or healthcare systems can result in lower per-unit prices due to bulk discounts.
What is the competitive landscape for naloxone hydrochloride, and who are the key manufacturers?
The naloxone hydrochloride market is characterized by a mix of generic and branded products, with several key manufacturers vying for market share. Competition is increasing as demand rises and public health initiatives promote broader access.
Major Market Participants
- Teva Pharmaceuticals: A significant provider of generic naloxone hydrochloride injectable solutions.
- Amneal Pharmaceuticals: Another major player in the generic naloxone market.
- Hikma Pharmaceuticals: Offers naloxone hydrochloride for injection.
- Kaleo Pharmaceuticals: Known for its Evzio auto-injector, a branded naloxone product.
- Aptar Pharma: While not a direct drug manufacturer, Aptal is a key supplier of nasal spray devices used by pharmaceutical companies to deliver naloxone.
- Naloxone manufacturers utilizing nasal spray devices: These include various pharmaceutical companies that license or develop naloxone nasal spray products.
The presence of multiple generic manufacturers for injectable naloxone (NDC 65162-0556) implies a competitive pricing environment for this specific formulation. Branded products with novel delivery systems or enhanced features may face less direct price competition.
What are the regulatory considerations and patent landscape impacting naloxone hydrochloride?
Regulatory approvals from bodies like the U.S. Food and Drug Administration (FDA) are critical for market entry and continued sales of naloxone hydrochloride. The patent landscape, while less characterized by novel drug patents for naloxone itself (as it is an older molecule), can still impact branded formulations and delivery devices.
Regulatory and Patent Dynamics
- FDA Approval: All naloxone products must undergo rigorous FDA review and approval processes to ensure safety and efficacy. This includes New Drug Applications (NDAs) for new formulations and Abbreviated New Drug Applications (ANDAs) for generic versions.
- Over-the-Counter (OTC) Status: In recent years, the FDA has approved naloxone nasal spray products for Over-the-Counter sales, expanding accessibility beyond prescription channels. This move significantly impacts the market by reducing barriers to access for consumers.
- Patent Protection: While the basic naloxone molecule is off-patent, patents can exist for specific drug delivery systems (e.g., auto-injectors, unique nasal devices), manufacturing processes, or combination therapies involving naloxone. These patents can grant market exclusivity for branded products.
- Exclusivity Periods: Generic drug manufacturers must navigate patent expirations and potential litigation to enter the market. Approved generic versions typically benefit from market exclusivity periods after patent challenges are resolved.
- Good Manufacturing Practices (GMP): Manufacturers must adhere to strict GMP regulations to ensure product quality and consistency, impacting production costs and market compliance.
The regulatory pathway for OTC naloxone nasal spray has broadened access, potentially influencing the demand for prescription and injectable forms. For NDC 65162-0556, which is typically an injectable formulation, the focus remains on generic competition and efficient manufacturing.
What are the future market projections and potential disruptions for naloxone hydrochloride?
The future market for naloxone hydrochloride is expected to continue its upward trajectory, driven by persistent opioid crisis trends and evolving public health strategies. Potential disruptions could arise from changes in government policy, advancements in addiction treatment, or the emergence of novel overdose reversal agents.
Future Outlook and Potential Disruptions
- Sustained Demand Growth: The ongoing opioid epidemic, particularly driven by fentanyl, ensures continued high demand for naloxone. Public health efforts to embed naloxone in community settings will further solidify this demand.
- Increased Generic Penetration: As patents expire for branded formulations or delivery devices, expect further growth in generic competition, potentially driving down prices for certain product types.
- Technological Advancements in Delivery: Innovation in easier-to-use, more stable, or combination delivery devices could shift market preferences. This includes improved nasal sprays or more affordable auto-injectors.
- Policy Shifts: Changes in government funding for addiction services, naloxone distribution programs, or prescribing mandates could impact market volume.
- Emergence of Novel Therapies: While naloxone is the current gold standard, research into longer-acting opioid antagonists or alternative overdose reversal mechanisms could eventually disrupt the market, though this is a long-term prospect.
- Supply Chain Resilience: Increased focus on diversifying manufacturing and supply chains will be crucial to mitigate future shortages and price volatility.
The market for NDC 65162-0556, as a specific injectable formulation, is likely to see continued demand from institutional buyers and healthcare providers who prefer or require this administration route. Its pricing will remain sensitive to generic competition and manufacturing efficiency.
Key Takeaways
The naloxone hydrochloride market, including NDC 65162-0556, is poised for steady growth, propelled by the unabated opioid crisis and supportive public health policies. While the generic injectable market faces competitive pricing, overall demand remains robust due to critical overdose reversal needs. Manufacturers must navigate evolving regulatory landscapes and supply chain dynamics to capitalize on future market opportunities.
Frequently Asked Questions
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What is the primary difference in availability between naloxone nasal spray and injectable formulations like NDC 65162-0556? Nasal spray formulations have seen a significant shift towards Over-the-Counter (OTC) availability in many regions, reducing the need for a prescription. Injectable formulations like NDC 65162-0556 are generally available via prescription, though they are also supplied to emergency medical services and public health programs.
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How do manufacturing costs for injectable naloxone hydrochloride compare to nasal spray devices? Injectable naloxone hydrochloride manufacturing involves standard pharmaceutical chemical synthesis and sterile filling processes. Nasal spray devices, conversely, incorporate proprietary drug delivery mechanisms, which can add to the overall manufacturing and assembly complexity and cost compared to a simple vial and syringe.
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Are there any specific patent protections that would differentiate NDC 65162-0556 from other injectable naloxone products? NDC 65162-0556 typically represents a generic formulation of naloxone hydrochloride for injection. Generic products do not have their own unique active ingredient patents but rely on the expiration of patents held by originator products, particularly regarding formulation, manufacturing processes, or specific delivery methods if applicable. The primary differentiator for generic injectables is usually manufacturing efficiency and cost.
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What is the typical shelf life for naloxone hydrochloride injectable solutions (NDC 65162-0556)? The shelf life for naloxone hydrochloride injectable solutions typically ranges from 18 to 36 months, depending on the specific manufacturer and product formulation. Proper storage conditions, as specified by the manufacturer, are essential to maintain efficacy.
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How does the pricing of naloxone hydrochloride under government contracts typically compare to retail pricing? Government contracts, often involving large bulk purchases by federal agencies or state health departments, usually secure significantly lower per-unit pricing for naloxone hydrochloride compared to retail or pharmacy prices. These contracts leverage economies of scale and negotiated discounts.
Cited Sources
[1] Centers for Disease Control and Prevention. (2023). Drug Overdose Deaths. Retrieved from [CDC Website]
[2] Grand View Research. (2023). Naloxone Market Size, Share & Trends Analysis Report.
[3] U.S. Food and Drug Administration. (2024). FDA Approves First Over-the-Counter Naloxone Nasal Spray. Retrieved from [FDA Website]
[4] Multiple pharmaceutical company product information and investor reports. (Data compiled from publicly available sources, specific internal company data not accessible).
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