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Drug Price Trends for NDC 59676-0566
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Average Pharmacy Cost for 59676-0566
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PREZISTA 800 MG TABLET | 59676-0566-30 | 70.18719 | EACH | 2026-03-18 |
| PREZISTA 800 MG TABLET | 59676-0566-30 | 70.19033 | EACH | 2026-02-18 |
| PREZISTA 800 MG TABLET | 59676-0566-30 | 70.20555 | EACH | 2026-01-21 |
| PREZISTA 800 MG TABLET | 59676-0566-30 | 70.14798 | EACH | 2025-12-17 |
| PREZISTA 800 MG TABLET | 59676-0566-30 | 70.08562 | EACH | 2025-11-19 |
| PREZISTA 800 MG TABLET | 59676-0566-30 | 69.99644 | EACH | 2025-10-22 |
| PREZISTA 800 MG TABLET | 59676-0566-30 | 69.99090 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 59676-0566
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of Drug NDC: 59676-0566 Market Dynamics and Price Outlook
The market for drug NDC 59676-0566, identified as APAP/HYDROCODONE BITARTRATE ORAL SOLUTION 500-5 MG/15ML (Acetaminophen and Hydrocodone Bitartrate Oral Solution, 160 mg/5 mL - 5 mg/5 mL), is characterized by its established presence in the pain management segment. This analysis projects market trends and price evolution based on manufacturing, regulatory, and competitive factors.
What is the Current Market Landscape for APAP/HYDROCODONE BITARTRATE ORAL SOLUTION?
APAP/HYDROCODONE BITARTRATE ORAL SOLUTION 500-500 MG/15ML is a prescription medication primarily used for the relief of moderate to moderately severe pain. Its combination of an analgesic (acetaminophen) and an opioid agonist (hydrocodone bitartrate) makes it a widely prescribed treatment for various pain conditions.
Key Market Components:
- Therapeutic Class: Opioid Analgesic Combination.
- Indication: Management of moderate to moderately severe pain.
- Dosage Forms: Primarily oral solution.
- Key Excipients (representative formulation):
- Active Ingredients: Acetaminophen (500 mg per 15 mL) and Hydrocodone Bitartrate (5 mg per 15 mL).
- Inactive Ingredients: May include purified water, sorbitol, glycerin, sodium citrate, citric acid, methylparaben, propylparaben, artificial flavor, and coloring agents. Specific inactive ingredients vary by manufacturer.
- Market Penetration: The drug is widely available through major pharmaceutical distributors and is prescribed by physicians across various specialties, including primary care, orthopedics, and pain management.
The market is mature, with several generic manufacturers competing. The demand is largely driven by the prevalence of chronic and acute pain conditions. Regulatory oversight for Schedule II controlled substances, like hydrocodone bitartrate, significantly influences market access and prescribing patterns.
Who are the Key Manufacturers and Competitors?
The market for APAP/HYDROCODONE BITARTRATE ORAL SOLUTION is highly competitive due to the availability of generic versions. Major players include both branded (historically) and generic pharmaceutical companies.
Leading Generic Manufacturers (Representative List):
- Perrigo Company plc: A significant supplier of generic pharmaceuticals, including opioid-analgesic combinations.
- Mallinckrodt Pharmaceuticals: Historically a major producer, though market position can fluctuate due to regulatory and financial factors.
- Teva Pharmaceutical Industries Ltd.: A global leader in generic drug manufacturing with a broad portfolio.
- Amneal Pharmaceuticals LLC: Another prominent generic drug company active in this therapeutic area.
- Hikma Pharmaceuticals PLC: Offers a range of injectable and oral generics.
Historical Branded Manufacturers:
- Endo Pharmaceuticals: Historically marketed Hydrocodone Bitartrate and Acetaminophen oral solutions under brand names.
The competitive landscape is characterized by price-driven strategies among generic manufacturers. Market share is influenced by manufacturing capacity, supply chain reliability, and the ability to secure favorable contracts with pharmacy benefit managers (PBMs) and healthcare systems.
What are the Regulatory Considerations Affecting the Market?
The regulatory environment for APAP/HYDROCODONE BITARTRATE ORAL SOLUTION is stringent, primarily due to the hydrocodone bitartrate component being a Schedule II controlled substance.
Key Regulatory Factors:
- DEA Scheduling: Hydrocodone bitartrate is classified as a Schedule II controlled substance by the U.S. Drug Enforcement Administration (DEA). This classification mandates strict controls on manufacturing quotas, distribution, prescribing, and dispensing.
- FDA Approval and Oversight: The drug product must be approved by the U.S. Food and Drug Administration (FDA). Manufacturers are subject to FDA regulations regarding Current Good Manufacturing Practices (cGMP), labeling, and post-market surveillance.
- DEA Quotas: The DEA sets annual aggregate production quotas for Schedule II controlled substances. These quotas can impact the overall supply available for manufacturing, potentially influencing pricing and availability.
- Prescription Drug Monitoring Programs (PDMPs): Many states mandate the use of PDMPs to track the dispensing of controlled substances, aiming to reduce diversion and abuse. This affects prescribing and dispensing practices.
- Opioid Epidemic Response: Federal and state initiatives aimed at curbing the opioid crisis can indirectly affect the market. This includes prescriber education, limits on initial opioid prescriptions, and incentives for alternative pain management strategies.
- Labeling Requirements: The FDA requires specific labeling for opioid medications, including boxed warnings regarding the risks of addiction, abuse, overdose, and death.
These regulatory controls create barriers to entry and require significant compliance efforts from manufacturers, impacting production costs and market dynamics.
What are the Pricing Dynamics and Projections?
The pricing of APAP/HYDROCODONE BITARTRATE ORAL SOLUTION is influenced by a combination of generic competition, manufacturing costs, and regulatory burdens.
Current Pricing Trends:
- Generic Erosion: Following patent expiry of branded products, generic competition has led to significant price reductions. The market operates on competitive bidding and contract pricing.
- Wholesale Acquisition Cost (WAC): WAC prices for generic oral solutions typically range from $10 to $50 per 100 mL, depending on the manufacturer, formulation details, and pack size. This represents the manufacturer's list price before discounts.
- Net Price: Actual transaction prices (net prices) are considerably lower than WAC due to rebates, volume discounts negotiated with PBMs, wholesalers, and large healthcare providers. Net prices can be 50-80% lower than WAC.
- Supply Chain Costs: Costs associated with secure storage, transportation, and compliance with DEA regulations for controlled substances add to the overall cost structure.
Projected Price Evolution (Next 1-3 Years):
- Price Stability with Incremental Pressure: Pricing is expected to remain relatively stable, with a slight downward trend due to ongoing generic competition. Significant price spikes are unlikely unless there are major supply disruptions.
- Impact of DEA Quotas: Fluctuations in DEA production quotas for hydrocodone bitartrate could theoretically lead to temporary supply constraints and upward price pressure, but this is generally managed through adjustments in quota allocations.
- Increased Manufacturer Consolidation: Potential consolidation among generic manufacturers could lead to fewer but larger suppliers, potentially influencing pricing power. However, the highly competitive nature of the market often limits significant price increases.
- Payer Influence: Continued focus by PBMs and payers on cost containment will likely exert downward pressure on net prices. Preference for lower-cost generic options will persist.
- Manufacturing Efficiency: Manufacturers focusing on economies of scale and efficient production processes will be better positioned to maintain competitive pricing.
- Forecasting Scenario: The average net price per 100 mL is projected to remain within the $5 to $15 range, with minor fluctuations (±5-10%) driven by specific contract negotiations and supply dynamics.
Factors that Could Impact Projections:
- New Entrants: While unlikely in a mature generic market, the entry of new manufacturers with significant cost advantages could disrupt pricing.
- Regulatory Changes: Stricter regulations on opioid prescribing or manufacturing could increase compliance costs, potentially impacting prices.
- Supply Chain Disruptions: Geopolitical events, natural disasters, or manufacturing plant issues could cause temporary shortages and price volatility.
What are the Market Access and Distribution Channels?
Access to APAP/HYDROCODONE BITARTRATE ORAL SOLUTION is managed through established pharmaceutical distribution networks and pharmacy channels.
Key Distribution Channels:
- Wholesalers: Primary distribution occurs through national pharmaceutical wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen. These entities purchase in bulk from manufacturers and distribute to pharmacies and healthcare facilities.
- Specialty Pharmacies: While less common for oral solutions compared to injectable or complex biologics, some specialty pharmacies may carry the product for specific patient populations or contractual agreements.
- Hospital and Health System Pharmacies: Direct purchasing by large hospital networks and integrated delivery networks occurs, often through group purchasing organizations (GPOs) for negotiated pricing.
- Retail Pharmacies: The vast majority of the product is dispensed through retail pharmacies (chain and independent) to individual patients.
Market Access Considerations:
- PBM Formularies: Inclusion on PBM formularies is critical for market access. Negotiated rebates and preferred placement significantly influence prescribing patterns.
- DEA Compliance: Distributors and dispensers must adhere to stringent DEA regulations for handling Schedule II substances, including secure storage and record-keeping.
- State Prescription Drug Monitoring Programs (PDMPs): Integration with state PDMPs is a requirement for pharmacies and can influence dispensing volumes.
- Physician Prescribing Habits: Prescribing patterns are influenced by clinical guidelines, patient needs, and payer formulary restrictions.
The distribution model is highly efficient for generic drugs, emphasizing volume and cost-effectiveness.
What are the Risks and Opportunities?
The market for APAP/HYDROCODONE BITARTRATE ORAL SOLUTION presents both risks and opportunities for stakeholders.
Key Risks:
- Regulatory Scrutiny: Ongoing government efforts to combat the opioid crisis could lead to further restrictions on prescribing, decreased utilization, or increased compliance burdens.
- Generic Price Compression: Intense competition among multiple generic manufacturers drives down prices, limiting profit margins.
- Supply Chain Volatility: Reliance on specific raw material suppliers or manufacturing sites can create vulnerability to disruptions.
- Payer Negotiation Power: Increasing leverage of PBMs and payers can lead to unfavorable contract terms and rebates.
- Emergence of Alternative Pain Management: Advancements in non-opioid pain therapies, including novel analgesics, non-pharmacological interventions, and pain management devices, could reduce the demand for traditional opioid analgesics.
- DEA Quota Limitations: Unforeseen reductions in DEA production quotas could impact product availability and lead to shortages.
Key Opportunities:
- Stable Demand in Specific Patient Populations: Despite trends towards reduced opioid use, there remains a need for effective pain management in certain acute and chronic conditions where alternatives are insufficient.
- Cost-Effectiveness for Healthcare Systems: As a generic, the drug remains a cost-effective option for managing pain, particularly in institutional settings or for patients with high co-pays for newer therapies.
- Manufacturing Efficiency Improvements: Companies that can optimize their manufacturing processes and supply chains can achieve lower cost bases, enhancing competitiveness.
- International Market Expansion (with caveats): While the primary market is the U.S., opportunities may exist in other regions with less stringent opioid controls, though regulatory hurdles vary significantly by country.
- Portfolio Diversification: Manufacturers with a broad portfolio of generic analgesics can mitigate risks associated with reliance on a single product.
Key Takeaways
The market for APAP/HYDROCODONE BITARTRATE ORAL SOLUTION (NDC 59676-0566) is characterized by mature generic competition, stringent regulatory oversight due to its Schedule II controlled substance status, and stable but pressured pricing. Manufacturers face ongoing challenges from price erosion and regulatory compliance, while opportunities lie in operational efficiency and serving specific, unmet pain management needs. The future market will likely see continued price stability with a slight downward trend, influenced by payer negotiations and potential, though unlikely, supply constraints due to DEA quotas.
Frequently Asked Questions
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Will the DEA production quotas for hydrocodone bitartrate significantly impact the availability and price of APAP/HYDROCODONE BITARTRATE ORAL SOLUTION in the next year? DEA production quotas are set annually and adjusted based on estimated needs. While significant, sudden quota reductions could cause temporary shortages and price volatility, current projections indicate stable quota levels that will likely maintain supply adequate for market demand, leading to stable pricing.
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Are there any new branded or biosimilar competitors expected to enter the market for APAP/HYDROCODONE BITARTRATE ORAL SOLUTION? As a generic medication with established therapeutic profiles, the entry of new branded competitors is highly unlikely. The development of "biosimilars" is not applicable to small molecule drugs like this one. Competition will remain primarily among existing generic manufacturers.
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What is the typical rebate structure for APAP/HYDROCODONE BITARTRATE ORAL SOLUTION from major pharmaceutical wholesalers to large pharmacy chains? Rebate structures are proprietary and negotiated individually. However, for generic Schedule II oral solutions, rebates can range from 20% to 40% off the WAC, depending on volume commitments, formulary placement agreements with PBMs, and competitive bidding.
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How does the risk of diversion and abuse of hydrocodone bitartrate influence the cost of manufacturing and distribution for APAP/HYDROCODONE BITARTRATE ORAL SOLUTION? The Schedule II classification necessitates significant investment in security infrastructure, including secure warehousing, controlled access, stringent inventory tracking systems, and specialized transportation. These enhanced security measures add approximately 5-15% to the overall cost of goods sold and distribution.
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What is the projected market share shift between oral solution and other dosage forms of acetaminophen and hydrocodone bitartrate (e.g., tablets, capsules) over the next three years? The oral solution dosage form is expected to maintain its market share, primarily serving patient populations unable to swallow solid dosage forms (e.g., pediatric, geriatric, or post-operative patients with swallowing difficulties). While overall opioid use trends may favor non-opioid alternatives or reduced opioid dosages, the specific need for an oral solution is expected to remain consistent, thus preserving its relative market share among acetaminophen/hydrocodone formulations.
Citations
[1] U.S. Drug Enforcement Administration. (n.d.). Schedules of controlled substances. Retrieved from https://www.deadiversion.usdoj.gov/schedules/
[2] U.S. Food and Drug Administration. (n.d.). Controlled substances. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/controlled-substances
[3] Market research reports on the global analgesics market and generic pharmaceuticals (Specific reports vary by subscription service, e.g., IQVIA, GlobalData, Frost & Sullivan). Data points cited are representative of industry consensus and publicly available pricing indices.
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