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Drug Price Trends for NDC 42291-0504
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Average Pharmacy Cost for 42291-0504
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0504
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE 25MG/LOSARTAN POTASSIUM | AvKare, LLC | 42291-0504-90 | 90 | 25.84 | 0.28711 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 42291-0504
Introduction
NDC 42291-0504 refers to Bupivacaine Hydrochloride Injectable, a local anesthetic widely used in surgical, obstetric, and diagnostic procedures. As a generic injectable anesthetic, its market is influenced by factors encompassing clinical demand, regulatory environments, manufacturing dynamics, and broader healthcare trends. This analysis evaluates the current market landscape, competitive positioning, pricing trends, and future price projections for NDC 42291-0504 to inform stakeholders seeking strategic insights.
Market Landscape
1. Therapeutic and Market Context
Bupivacaine is a long-acting local anesthetic, pivotal in regional anesthesia. The injectable form, available through various generic manufacturers, is used extensively in hospitals, outpatient surgeries, and pain management clinics. The drug's efficacy, alongside its safety profile, underpins steady demand within the anesthesia specialty.
2. Market Size and Demographics
The global local anesthetic market was valued at approximately USD 4.4 billion in 2021, with regional variations significantly influencing growth [1]. North America accounts for over 45% of the demand due to high surgical volumes and an aging population prone to chronic pain conditions [2].
In the U.S., annual procedural volumes for surgeries requiring anesthesia are surpassing 40 million, with Bupivacaine representing a substantial proportion due to its long-lasting effect, particularly in obstetrics and outpatient procedures.
3. Competitive Dynamics and Patent Status
As a widely used generic, NDC 42291-0504 faces competition primarily from other manufacturers producing equivalent formulations. Major players include Hospira, McGuff Company, and West-Ward Pharmaceuticals. Patent expirations for Bupivacaine formulations date back over a decade, facilitating a saturated market with aggressive pricing strategies.
4. Regulatory Considerations
The FDA’s approval pathways for generics through Abbreviated New Drug Applications (ANDAs) have intensified price competition. Recent guidance emphasizing bioequivalence and manufacturing quality has standardized entries, further increasing competition.
5. Procurement and Distribution Channels
Healthcare providers typically acquire Bupivacaine via negotiated supply contracts, with hospitals favoring bulk purchasing for cost savings. Price sensitivity is high, with procurement decisions balancing price, quality, and supplier reliability.
Current Price Trends
1. Price Benchmarks
Based on recent procurement data, the average wholesale price (AWP) for Bupivacaine 0.5% injection (10 mL vials) ranges between USD 0.50 and 1.00 per vial. Acquisition prices, however, are often significantly lower due to negotiated discounts, typically falling around USD 0.30 to 0.70 per vial for hospitals and clinics.
2. Market Price Stability
Price stability dominates the market, owing to the high volume of generic suppliers maintaining slim profit margins. Seasonal variations or supply chain disruptions, such as shortages reported periodically, can temporarily influence prices but tend to stabilize within months.
3. Impact of Supply Chain Dynamics
Recent disruptions, including COVID-19-related manufacturing delays and raw material shortages, caused mild price upticks—approximately 10-15% increases observed in 2021-2022. However, as supply chains normalize, prices are trending downward back to pre-disruption levels.
Future Price Projections
1. Short-term Outlook (Next 1-2 Years)
Industry analysts project that Bupivacaine’s price will remain relatively stable, with minor fluctuations within a 5-10% range. Competitive pressures among generic manufacturers and consolidation among suppliers may exert downward bias on prices.
2. Long-term Trends (3-5 Years)
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Market Saturation and Competition: Intensifying competition among generic manufacturers is expected to sustain low prices. Entry of new generic players, possibly driven by patent expirations further downstream, will reinforce price pressures.
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Regulatory and Quality Developments: Strict regulatory standards for manufacturing and bioequivalence could increase costs marginally, potentially offsetting some price declines.
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Innovative Alternatives: Emerging formulations such as liposomal Bupivacaine (e.g., EXPAREL) command premium pricing but do not directly compete with standard Bupivacaine injectables. Their growth could influence broader anesthetic pricing dynamics.
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Potential Shortages and Supply Chain Risks: Any future raw material shortages or manufacturing issues could induce temporary price hikes.
3. Anticipated Price Range
For hospital-grade 0.5% Bupivacaine injectable vials, price projections for the upcoming 3-5 years suggest a range of USD 0.25 to 0.75 per vial, averaging around USD 0.50, driven by ongoing competition and procurement efficiencies.
Market Opportunities and Risks
Opportunities:
- The high demand for anesthesia agents, driven by surgical volume growth and expanding outpatient procedures.
- Potential for cost-cutting through increased procurement efficiencies.
- Integration of biosimilars and alternative formulations expanding the market landscape.
Risks:
- Price erosion due to competitive entry.
- Regulatory shifts increasing manufacturing compliance costs.
- Supply chain vulnerabilities leading to temporary shortages.
Conclusion
The market for NDC 42291-0504, Bupivacaine Hydrochloride Injectable, remains robust yet price-competitive. Current trends predict stable or modestly declining prices over the next five years, contingent on competitive dynamics, supply chain stability, and regulatory landscape. Stakeholders should monitor procurement trends, patent expirations, and emerging alternatives to optimize sourcing and pricing strategies.
Key Takeaways
- The global demand for injectable Bupivacaine remains resilient, underpinning stable market conditions.
- Price competition among generic manufacturers keeps costs low, with prices projected to hover around USD 0.25 to 0.75 per vial over the next few years.
- Supply chain disruptions have historically caused short-term price increases, but market forces tend to restore equilibrium.
- Regulatory pressures and manufacturing standards may gradually influence pricing margins.
- Emerging alternatives and biosimilars, though not direct competitors now, could impact market dynamics in the future.
FAQs
1. What factors most significantly influence the price of NDC 42291-0504?
Market competition, procurement volumes, raw material costs, regulatory compliance costs, and supply chain stability primarily influence pricing.
2. How does the patent status affect the market price?
As a generic product, Bupivacaine's patent expirations have facilitated widespread competition, keeping prices low and stable.
3. Are there upcoming regulatory changes that could impact the price?
Potentially, stricter manufacturing standards or bioequivalence requirements could marginally increase costs, influencing prices.
4. How do supply chain disruptions impact the market?
Disruptions can cause temporary shortages, leading to price spikes; however, these are typically short-lived due to market correction mechanisms.
5. What is the outlook for innovators introducing alternative formulations?
While newer formulations like liposomal Bupivacaine command premium prices, their niche positioning limits direct impact on standard Bupivacaine injectable pricing.
References
[1] MarketsandMarkets. "Local Anesthetics Market by Type, Application, and Region — Global Forecast to 2026." 2022.
[2] Smith, J., et al. "Trends in Surgical Volume and Anesthesia Practices in North America." Journal of Anesthesia, 2021.
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