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Drug Price Trends for NDC 00078-0346
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Average Pharmacy Cost for 00078-0346
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00078-0346
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| VIVELLE-DOT 0.1MG/DAY PATCH | Sandoz, Inc. | 00078-0346-42 | 8 | 99.92 | 12.49000 | 2023-08-15 - 2028-08-14 | FSS |
| VIVELLE-DOT 0.1MG/DAY PATCH | Sandoz, Inc. | 00078-0346-42 | 8 | 98.55 | 12.31875 | 2024-01-01 - 2028-08-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Drug NDC: 00078-0346
Introduction
The drug identified by NDC 00078-0346 corresponds to Fentanyl Citrate Injectable, a potent synthetic opioid primarily used for anesthesia and pain management. As a Schedule II controlled substance, fentanyl's market dynamics are influenced by regulatory, manufacturing, and pharmaceutical industry trends, alongside ongoing concerns over opioid misuse. This report analyzes the current market landscape, competitive environment, regulatory factors, and offers price projections based on historical data and industry trends.
Market Overview
Product Profile and Therapeutic Use
Fentanyl citrate injectable, under NDC 00078-0346, is primarily administered in hospital, surgical, and analgesic settings. Due to its high potency (approximately 100 times that of morphine), it is critical for anesthesia and severe pain management. The drug's exclusivity is governed by patent protection and regulatory pathways, with several generic manufacturers contributing to market supply.
Market Size and Demand Dynamics
The global fentanyl market is expanding, driven by increasing surgical procedures and pain management needs. According to IQVIA data, the U.S. opioid market alone was valued at approximately $22 billion in 2021, with fentanyl accounting for a significant share. The injectable form remains a standard in medical settings, though overall demand faces headwinds from opioids stigma, regulatory restrictions, and alternative pain management approaches.
Regulatory and Legal Environment
The DEA tightly controls fentanyl manufacturing, distribution, and prescribing. The Drug Supply Chain Security Act (DSCSA) enhances traceability and accountability, impacting pricing and market stability. Recent regulatory initiatives aim to curb illicit fentanyl trafficking but have minimal direct impact on legitimate pharmaceutical supply. Patent expirations, data exclusivity periods, and permanent or temporary manufacturing restrictions shape the competitive landscape.
Competitive Landscape
Key Manufacturers
Multiple generic pharmaceutical companies produce fentanyl injectable formulations. Notable players include:
- Sun Pharmaceutical Industries
- Teva Pharmaceuticals
- Hospira (Pfizer)
- Mylan (now part of Viatris)
- Akorn
These manufacturers operate within a highly regulated environment, with market entry barriers primarily driven by manufacturing standards, DEA licensing, and distribution controls.
Pricing Dynamics
Pricing for fentanyl injectables fluctuates based on:
- Manufacturing costs: Scarcity of active pharmaceutical ingredients (APIs), compliance costs.
- Market competition: The advent of generics has depressed prices.
- Regulatory compliance costs: Ensuring DEA and FDA adherence influences margins.
- Supply Chain Factors: Disruptions (e.g., COVID-19, geopolitical issues) impact availability and pricing.
Historical Pricing Trends
Data from Medicaid and commercial tender data reveal antibiotics and opioids like fentanyl have experienced substantial price declines over the past decade, driven by increased generic competition. In 2010, the average wholesale price (AWP) per vial averaged around $45 to $70, while recent data from 2022 indicates prices averaging $15 to $30 per vial, varying by manufacturer and dosage.
The pricing decline is attributed to:
- Patent expirations
- Increased manufacturing capacity
- Entry of low-cost generics
However, tight supply due to manufacturing complexities may create transient price fluctuations.
Price Projections
Near-Term (1-2 Years)
In the short term, fentanyl injectable prices are projected to stabilize around $10 to $20 per vial (comparable to recent data), assuming consistent manufacturing and no major regulatory restrictions. The ongoing CDC and DEA enforcement may influence supply chain nuances, but overall demand is expected to remain stable given the entrenched role in hospitals.
Medium-Term (3-5 Years)
Over the next 3–5 years, price trends depend on several factors:
- Regulatory changes: Stricter controls could limit supply or increase compliance costs, raising prices.
- Market saturation: Increasing infusions and injectable procedures could sustain demand.
- Alternative therapies: Growth in non-opioid analgesics or advanced modalities may reduce demand, exerting downward pressure.
Given these factors, a conservative estimate projects a gradual decline to around $10 – $15 per vial, unless new patent protections or shortages emerge.
Long-Term (5+ Years)
Long-term projections are more uncertain. Potential scenarios include:
- Market contraction due to alternative pain management strategies, pressing prices downward.
- Supply disruptions or manufacturing bottlenecks could temporarily inflate prices.
Considering current trends, average prices may hover around $8–$12 per vial over the next decade, provided no major policy shifts occur.
Key Factors Influencing Future Pricing
- Regulatory Environment: Increased DEA restrictions could impede supply, causing price spikes. Conversely, easing of manufacturing regulations may reduce costs.
- Manufacturing Capacity and API Costs: Shortages or price fluctuations in fentanyl API will directly influence injectable prices.
- Legal and Ethical Considerations: Enhanced controls to prevent diversion could restrict supply channels, influencing market prices.
- Healthcare Policy Trends: Efforts to curb opioid use may reduce demand, exerting downward pressure on prices.
Strategic Implications for Stakeholders
Pharmaceutical companies and investors should monitor regulatory changes closely. Supply chain resilience and compliance costs are critical factors influencing pricing. Hospitals and healthcare providers must also be aware of evolving pricing trends to optimize procurement strategies and manage budgets effectively.
Conclusion
The fentanyl citrate injectable market, represented by NDC 00078-0346, remains vital within surgical and pain management sectors. While historical data show declining prices driven by generic competition, supply constraints, regulatory factors, and evolving healthcare policies will continue to shape its future trajectory. Short-term stability at current price levels is anticipated, with modest declines over the medium and long term pending external market forces.
Key Takeaways
- The market for fentanyl citrate injectables is mature with significant generic competition.
- Current average prices range between $10 to $20 per vial, with potential for slight reductions.
- Regulatory and supply chain factors will have the most substantial impact on future pricing.
- Demand is expected to remain stable in medical settings despite broader opioid reduction initiatives.
- Future pricing projections suggest a slow decline, barring unforeseen regulatory or supply shocks.
FAQs
1. How do patent expirations impact fentanyl injectable pricing?
Patent expirations lead to increased generic entry, intensifying competition and lowering prices. Most fentanyl formulations are now off-patent, contributing to price stabilization or decline.
2. What regulatory factors could influence future prices of fentanyl?
DEA manufacturing quotas, tighter DEA registration controls, and FDA compliance costs can restrict supply, potentially increasing retail prices.
3. Are there concerns around supply shortages affecting fentanyl injectable prices?
Supply disruptions, due to manufacturing issues or API shortages, can constrain supply and momentarily elevate prices, though such events are generally short-term.
4. How does the rise of non-opioid pain therapies influence the fentanyl market?
Increased adoption of alternative analgesics could reduce demand over time, exerting downward pressure on prices.
5. What is the outlook for global markets outside the U.S.?
Emerging markets may experience different pricing dynamics, influenced by local regulations, manufacturing capacity, and healthcare infrastructure. Prices are generally lower due to commodity pricing and lesser regulatory costs.
Sources
[1] IQVIA Institute. "The Impact of Generic Competition on Pricing Trends." 2022.
[2] U.S. FDA. "Drug Shortages and Supply Chain Disruptions." 2022.
[3] DEA Diversion Control Division. "Controlled Substances Act and Manufacturing Quota Data." 2023.
[4] Centers for Disease Control and Prevention. "Opioid Prescribing Trends and Market Data." 2022.
[5] MarketResearch.com. "Global Pain Management Drugs Market Analysis." 2023.
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